21 results on '"Tanara Vieira Sousa"'
Search Results
2. The HOMESIDE Study—A Research Project to Support People Living With Dementia and Their Family Caregivers: Preliminary Report on Reading Intervention
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Agnieszka Smrokowska-Reichmann PhD, Edyta Janus PhD, Jeanette Tamplin PhD, Helen Odell-Miller PhD, Karette Stensæth PhD, Jennifer Wenborn PhD, Rønnaug Modell Viken, Thomas Wosch PhD, Anna A. Bukowska PhD, Tanara Vieira Sousa PhD, and Felicity Anne Baker PhD
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Geriatrics ,RC952-954.6 - Abstract
The behavioral and psychological symptoms of dementia (BPSD) can be challenging for family caregivers to cope with, leading to distress and fatigue. It is therefore important to offer effective strategies to reduce the impact of BPSD. The HOMESIDE randomized controlled trial (RCT) was testing purposefully developed interventions to improve the quality of life and wellbeing of dyads of people with dementia and family caregivers as a result of reduction of BPSD. HOMESIDE RCT was conducted in Australia, Germany, Norway, Poland and the United Kingdom between 2019 and 2022. The study design was a three-arm parallel-group single-blinded, pragmatic RCT with a sample size of 432 dyads. Dyads were randomly allocated to one of three treatment conditions: Music Intervention plus Standard Care; or Reading Intervention plus Standard Care; or Standard Care only. The Reading Intervention (RI) within the HOMESIDE RCT aimed to evoke shared discussion, reminiscence, meaningful shared experiences and consequently enrich everyday life, interaction and the emotional connection between the caregiver (CG) and carereceiver (CR); as well as to enhance activities of daily living and to promote relaxation or stimulation as appropriate. This paper describes the underlying conceptual framework, the content, and delivery of the Reading Intervention within the HOMESIDE RCT.
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- 2024
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3. Statistical analysis plan for HOMESIDE: a randomised controlled trial for home-based family caregiver-delivered music and reading interventions for people living with dementia
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Vanessa Pac Soo, Felicity A. Baker, Tanara Vieira Sousa, Helen Odell-Miller, Karette Stensæth, Thomas Wosch, Anna A. Bukowska, Jeanette Tamplin, Nicola Lautenschlager, Sabine Braat, and Karen E. Lamb
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Dementia ,Music therapy ,Statistical analysis plan ,Randomised controlled trial ,Medicine (General) ,R5-920 - Abstract
Abstract Background Most people with dementia live in the community, not in residential care. Therefore, quality informal care for them is critical for managing behavioural and psychological symptoms of dementia (BPSD). Music therapy has been shown to reduce BPSD. However, no randomised controlled trial has examined the effects of music interventions delivered by caregivers in home settings. The HOME-based caregiver-delivered music intervention for people living with dementia (HOMESIDE) trial aims to evaluate the effectiveness of a 12-week music intervention in addition to standard care for BPSD. This article describes the statistical analysis plan. Methods and analysis HOMESIDE is a large, pragmatic international three-arm parallel-group randomised controlled trial. Dyads (persons with dementia and caregiver) in Australia, Germany, the UK, Poland and Norway were randomised to receive music and standard care, reading and standard care or standard care alone. The primary outcome is BPSD (proxy) of the person living with dementia, measured using the Neuropsychiatric Inventory-Questionnaire (NPI-Q) at 90 and 180 days post-randomisation. Longitudinal analysis will compare NPI-Q severity between music and standard care versus standard care alone. Secondary outcomes include quality of life and depression (both person with dementia and caregiver), cognition (person with dementia only), distress, resilience, competence and caregiver-patient relationship (caregiver only). Treatment effects will be obtained at 90 and 180 days post-randomisation, where applicable. Safety outcomes (adverse events, hospitalisations, deaths) will be summarised. Discussion This statistical analysis plan provides a detailed methodology for the analysis of HOMESIDE and will improve the validity of the study and reduce the potential for bias. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12618001799246. Registered on November 05, 2018. ClinicalTrials.gov NCT03907748. Registered on April 09, 2019.
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- 2023
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4. Home-based family caregiver-delivered music and reading interventions for people living with dementia (HOMESIDE trial): an international randomised controlled trialResearch in context
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Felicity Anne Baker, Vanessa Pac Soo, Jodie Bloska, Laura Blauth, Anna A. Bukowska, Libby Flynn, Ming Hung Hsu, Edyta Janus, Kjersti Johansson, Tone Kvamme, Nicola Lautenschlager, Hayley Miller, Jonathan Pool, Agnieszka Smrokowska-Reichmann, Karette Stensæth, Kate Teggelove, Sven Warnke, Thomas Wosch, Helen Odell-Miller, Karen Lamb, Sabine Braat, Tanara Vieira Sousa, and Jeanette Tamplin
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Dementia ,Family caregivers ,Music interventions ,Randomised controlled trial ,Behavioural and psychological symptoms of dementia ,Alzheimer's disease ,Medicine (General) ,R5-920 - Abstract
Summary: Background: Music interventions provided by qualified therapists within residential aged care are effective at attenuating behavioural and psychological symptoms (BPSD) of people with dementia (PwD). The impact of music interventions on dementia symptom management when provided by family caregivers is unclear. Methods: We implemented a community-based, large, pragmatic, international, superiority, single-masked randomised controlled trial to evaluate if caregiver-delivered music was superior to usual care alone (UC) on reducing BPSD of PwD measured by the Neuropsychiatric Inventory-Questionnaire (NPI-Q). The study included an active control (reading). People with dementia (NPI-Q score ≥6) and their caregiver (dyads) from one of five countries were randomly allocated to caregiver-delivered music, reading, or UC with a 1:1:1 allocation stratified by site. Caregivers received three online protocolised music or reading training sessions delivered by therapists and were recommended to provide five 30-min reading or music activities per week (minimum twice weekly) over 90-days. The NPI-Q severity assessment of PwD was completed online by masked assessors at baseline, 90- (primary) and 180-days post-randomisation and analysed on an intention-to-treat basis using a likelihood-based longitudinal data analysis model. ACTRN12618001799246; ClinicalTrials.gov NCT03907748. Findings: Between 27th November 2019 and 7th July 2022, we randomised 432 eligible of 805 screened dyads (music n = 143, reading n = 144, UC n = 145). There was no statistical or clinically important difference in the change from baseline BPSD between caregiver-delivered music (−0.15, 95% CI −1.41 to 1.10, p = 0.81) or reading (−1.12, 95% CI −2.38 to 0.14, p = 0.082) and UC alone at 90-days. No related adverse events occurred. Interpretation: Our findings suggested that music interventions and reading interventions delivered by trained caregivers in community contexts do not decrease enduring BPSD symptoms. Funding: Our funding was provided by National Health and Medical Research Council, Australia; The Research Council of Norway; Federal Ministry of Education and Research, Germany; National Centre for Research and Development, Poland; Alzheimer’s Society, UK, as part of the Joint Programme for Neurodegenerative Diseases consortia scheme.
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- 2023
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5. Content development and validation for a mobile application designed to train family caregivers in the use of music to support care of people living with dementia
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Zara Thompson, Jeanette Tamplin, Tanara Vieira Sousa, Romina Carrasco, Libby Flynn, Karen E. Lamb, Amit Lampit, Nicola T. Lautenschlager, Kate McMahon, Jenny Waycott, Adam P. Vogel, Robyn Woodward-Kron, Phoebe A. Stretton-Smith, and Felicity A. Baker
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dementia ,technology ,music therapy ,eHealth ,caregiver ,Medicine (General) ,R5-920 - Abstract
BackgroundMusic therapy is increasingly recognized as an effective support for people living with dementia. However, with incidences of dementia increasing, and limited availability of music therapists, there is a need for affordable and accessible ways that caregivers can learn to use music-therapy based strategies to support the people they care for. The MATCH project aims to address this by creating a mobile application that can train family caregivers in the use of music to support people living with dementia.MethodsThis study details the development and validation of training material for the MATCH mobile application. Training modules developed based on existing research were assessed by 10 experienced music therapist clinician-researchers, and seven family caregivers who had previously completed personalized training in music therapy strategies via the HOMESIDE project. Participants reviewed the content and scored each training module based on content (music therapists) and face (caregivers) validity scales. Descriptive statistics were used to calculate scores on the scales, while thematic analysis was used to analyze short-answer feedback.ResultsParticipants scored the content as valid and relevant, however, they provided additional suggestions for improvement via short-answer feedback.ConclusionThe content developed for the MATCH application is valid and will be trailed by family caregivers and people living with dementia in a future study.
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- 2023
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6. Comparing health gains, costs and cost-effectiveness of 100s of interventions in Australia and New Zealand: an online interactive league table
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Natalie Carvalho, Tanara Vieira Sousa, Anja Mizdrak, Amanda Jones, Nick Wilson, and Tony Blakely
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Cost-effectiveness ,League table ,Priority-setting ,Costs ,Health gains ,Computer applications to medicine. Medical informatics ,R858-859.7 ,Public aspects of medicine ,RA1-1270 - Abstract
Abstract Background This study compares the health gains, costs, and cost-effectiveness of hundreds of Australian and New Zealand (NZ) health interventions conducted with comparable methods in an online interactive league table designed to inform policy. Methods A literature review was conducted to identify peer-reviewed evaluations (2010 to 2018) arising from the Australia Cost-Effectiveness research and NZ Burden of Disease Epidemiology, Equity and Cost-Effectiveness Programmes, or using similar methodology, with: health gains quantified as health-adjusted life years (HALYs); net health system costs and/or incremental cost-effectiveness ratio; time horizon of at least 10 years; and 3% to 5% discount rates. Results We identified 384 evaluations that met the inclusion criteria, covering 14 intervention domains: alcohol; cancer; cannabis; communicable disease; cardiovascular disease; diabetes; diet; injury; mental illness; other non-communicable diseases; overweight and obesity; physical inactivity; salt; and tobacco. There were large variations in health gain across evaluations: 33.9% gained less than 0.1 HALYs per 1000 people in the total population over the remainder of their lifespan, through to 13.0% gaining > 10 HALYs per 1000 people. Over a third (38.8%) of evaluations were cost-saving. Conclusions League tables of comparably conducted evaluations illustrate the large health gain (and cost) variations per capita between interventions, in addition to cost-effectiveness. Further work can test the utility of this league table with policy-makers and researchers.
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- 2022
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7. Recruitment approaches and profiles of consenting family caregivers and people living with dementia: A recruitment study within a trial
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Felicity A. Baker, Laura Blauth, Jodie Bloska, Anna A. Bukowska, Libby Flynn, Ming-Hung Hsu, Edyta Janus, Kjersti Johansson, Helen Odell-Miller, Hayley Miller, Carina Petrowitz, Jonathan Pool, Karette Stensæth, Jeanette Tamplin, Kate Teggelove, Thomas Wosch, and Tanara Vieira Sousa
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Recruitment ,Clinical trial ,Dementia ,Caregiver ,Study enrolment ,Medicine (General) ,R5-920 - Abstract
Background: While studies have identified strategies that are useful for recruiting people living with dementia, none have focused on psychosocial interventions involving arts therapies, or have examined the profiles of older people living in the community who consent or decline participation, particularly during a global pandemic. We aimed to identify the most effective recruitment strategies according to participant characteristics and transnational differences and develop a profile of consenting and non-consenting participants. Methods: Recruitment teams in Australia, Norway, Germany, Poland, and the United Kingdom, recorded participants' source of study awareness and characteristics of consenting and non-consenting participants. Distributions of participants ‘consenting to participate’ were compared and logistic regressions were used to estimate the odds ratios. Results: Consenting female caregivers were disproportionally represented. Study awareness differed between countries but overall, most expressions of interest to participate were derived from referrals from professionals or organisations, or from databases of people wanting to participate in research. Troughs in recruitment rates occurred during Northern Hemisphere summer vacation periods, and during Christmas periods. Conclusions: This study found that recruiting for a trial with community-dwelling family caregivers and people living with dementia is challenging, especially during a global pandemic. While spousal caregivers comprised the highest proportion of dyads recruited, overall spousal caregivers were more reluctant to consent to participate than adult child caregivers. More targeted recruitment strategies designed for minority groups are also needed to ensure broader representation in dementia treatment studies.
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- 2023
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8. Promoting Independence Through quality dementia Care at Home (PITCH): a research protocol for a stepped-wedge cluster-randomised controlled trial
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Steven Savvas, Anita M. Y. Goh, Frances Batchelor, Colleen Doyle, Erica Wise, Esther Tan, Anita Panayiotou, Sue Malta, Margaret Winbolt, Phillip Clarke, Jason Burton, Lee-Fay Low, Samantha M. Loi, Anne Fairhall, Meg Polacsek, Jay Stiles, Fenny Muliadi, Nadia Chau, Samuel Scherer, David Ames, Tanara Vieira Sousa, and Briony Dow
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Home care ,Aged care ,Dementia ,Home care worker ,HCW ,Aged care staff ,Medicine (General) ,R5-920 - Abstract
Abstract Background Home care service providers are increasingly supporting clients living with dementia. Targeted and comprehensive dementia-specific training for home care staff is necessary to meet this need. This study evaluates a training programme delivered to care staff (paid personal carers) of clients living with dementia at home. Methods This study is a pragmatic stepped-wedge cluster-randomised controlled trial (SW-CRT). Home care workers (HCWs) from seven home care service providers are grouped into 18 geographical clusters. Clusters are randomly assigned to intervention or control groups. The intervention group receives 7 h of a dementia education and upskilling programme (Promoting Independence Through quality dementia Care at Home [PITCH]) after baseline measures. The control group receives PITCH training 6 months after baseline measures. This approach will ensure that all participants are offered the program. Home care clients living with dementia are also invited to participate, as well as their family carers. The primary outcome measure is HCWs’ sense of competence in dementia care provision. Discussion Upskilling home care staff is needed to support the increasing numbers of people living with dementia who choose to remain at home. This study uses a stepped-wedge cluster-randomised trial to evaluate a training programme (PITCH) for dementia care that is delivered to front-line HCWs. Trial registration anzctr.org.au ; ACTRN12619000251123. Registered on 20 February 2019.
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- 2021
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9. Care plus study: a multi-site implementation of early palliative care in routine practice to improve health outcomes and reduce hospital admissions for people with advanced cancer: a study protocol
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Jennifer Philip, Roslyn Le Gautier, Anna Collins, Anna K. Nowak, Brian Le, Gregory B. Crawford, Nicole Rankin, Meinir Krishnasamy, Geoff Mitchell, Sue-Anne McLachlan, Maarten IJzerman, Robyn Hudson, Danny Rischin, Tanara Vieira Sousa, and Vijaya Sundararajan
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Palliative care ,Integrated care ,Implementation ,Health services ,Public aspects of medicine ,RA1-1270 - Abstract
Abstract Background Current international consensus is that ‘early’ referral to palliative care services improves cancer patient and family carer outcomes. In practice, however, these referrals are not routine. An approach which directly addresses identified barriers to early integration of palliative care is required. This protocol details a trial of a standardized model of early palliative care (Care Plus) introduced at key defined, disease-specific times or transition points in the illness for people with cancer. Introduced as a ‘whole of system’ practice change for identified advanced cancers, the key outcomes of interest are population health service use change. The aims of the study are to examine the effect of Care Plus implementation on (1) acute hospitalisation days in the last 3 months of life; (2) timeliness of access to palliative care; (3) quality and (4) costs of end of life care; and (5) the acceptability of services for people with advanced cancer. Methods Multi-site stepped wedge implementation trial testing usual care (control) versus Care Plus (practice change). The design stipulates ‘control’ periods when usual care is observed, and the process of implementing Care Plus which includes phases of planning, engagement, practice change and evaluation. During the practice change phase, all patients with targeted advanced cancers reaching the transition point will, by default, receive Care Plus. Health service utilization and unit costs before and after implementation will be collated from hospital records, and state and national health service administrative datasets. Qualitative data from patients, consumers and clinicians before and after practice change will be gathered through interviews and focus groups. Discussion The study outcomes will detail the impact and acceptability of the standardized integration of palliative care as a practice change, including recommendations for ongoing sustainability and broader implementation. Trial registration Australian New Zealand Clinical Trials Registry ACTRN 12619001703190 . Registered 04 December 2019.
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- 2021
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10. Resource assessment in trials undertaken in residential care homes: Experiences from the Australian MIDDEL cluster randomised controlled trial research team
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Felicity A. Baker, Phoebe A. Stretton-Smith, Tanara Vieira Sousa, Imogen Clark, Alice Cotton, Christian Gold, and Young-Eun C. Lee
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Dementia ,Residential aged care ,Nursing homes ,Resource assessment ,Recruitment ,Music therapy ,Medicine (General) ,R5-920 - Abstract
Background: The resources involved in delivering a clinical trial in residential aged care facilities (RACFs) are significant and the success of a trial is dependent upon adequate planning, including appropriate timelines for each component of the study and the required budget. This paper describes process and resource assessment during recruitment, collection of outcome measures and intervention delivery, and presents learnings and considerations for conducting trials in RACFs with people living with dementia. Methods: Data were collected across 24 clusters in 12 RACFs over 18 months during a cluster randomised controlled trial which was testing the effectiveness of music interventions in people living with dementia. Data were collected on resources required for recruitment and assessment of baseline data, as well as reasons for participant non-attendance at the interventions. Results: Time between contacting next of kin and receiving formal consent often exceeded 45 days. The ratio of time between direct and indirect research activity was approximately 1:2. Participant intervention adherence is at risk from unplanned RACF lockdowns and reasons for non-attendance include those both related directly to the participant and to staff resources, scheduling or other practical considerations. Conclusions: Research planning should focus on building relationships with RACF staff and resident families, factor in adequate time for recruitment in the study timeline and consider budgeting for backfill of RACF staff during data collection phases to expedite the process and ensure adherence to study protocol timelines. Trial registration Australian and New Zealand Clinical Trial Registry: ANZCTR12618000156280, 1/02/2018, http://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12618000156280: A
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- 2020
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11. The Influence of Home-Based Music Therapy Interventions on Relationship Quality in Couples Living with Dementia—An Adapted Convergent Mixed Methods Study
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Kristi Stedje, Tone Sæther Kvamme, Kjersti Johansson, Tanara Vieira Sousa, Helen Odell-Miller, Karette Annie Stensæth, Anna A. Bukowska, Jeanette Tamplin, Thomas Wosch, and Felicity Anne Baker
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couples ,Health, Toxicology and Mutagenesis ,music therapy ,Public Health, Environmental and Occupational Health ,couplehood ,relationship quality ,music therapy interventions ,dementia - Abstract
Relationship quality is important for well-being and quality of life in couples living with dementia. Home-based music therapy interventions may be conducted with the aim of enhancing relationship quality. However, the effects or influences of such interventions are only briefly investigated in previous studies. This study’s aim was to identify how a 12-week home-based music therapy intervention may influence relationship quality in couples living with dementia, through an adapted convergent mixed methods design. In this case, 68 participating couples from the HOMESIDE RCT study, and four individually recruited couples, received the music therapy intervention. Relationship quality for all participants was measured by the standardized Quality of Caregiver-Patient Relationship scale, and qualitative interviews were conducted with the four individually recruited participants at baseline and post intervention. Quantitative analysis indicated no statistically significant intervention effect. However, relationship quality remained stable over the intervention period. The qualitative analysis identified that the music therapy interventions primarily led to positive emotions, closeness, intimacy, and communication between the persons with dementia and their care partners. Intervention influences could also be ambiguous, as sharing music experiences might involve a risk of evoking vulnerabilities or negative emotional responses.
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- 2023
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12. Understanding survey data available for researchers working in ageing: the CEPAR Metadata Database on Ageing
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Josh Knight, Libby Brooke, Jeromey Temple, Jay A. Stiles, Ruth F. G. Williams, and Tanara Vieira Sousa
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Metadata ,Computer science ,Survey data collection ,General Medicine ,Data science - Abstract
Background For researchers working in gerontology or the demography of ageing, knowledge of and access to population-based data, which includes mature age respondents, is critical. The collection of metadata (information describing data) supports researchers in their search for relevant data. Aims This proof-of-concept project seeks to develop a metadata database including metadata on Australian sample surveys relevant to ageing over the period 2010–2018. Data and methods We used a five-stage approach to create the Centre for Excellence in Population Ageing Research (CEPAR) metadata database on ageing: 1) identification of in-scope survey datasets; 2) indexing the in-scope surveys; 3) scraping metadata from publicly available sources; 4) appending metadata to a master database; and 5) creation of a webtool to enable users to search and export metadata and obtain contact details for the relevant data custodian. Results The CEPAR Metadata Database webtool is available from: https://mspgh.unimelb.edu.au/centres-institutes/centre-for-health-policy/research-group/metadata-database. Conclusions Metadata database collections can assist researchers to identify what data has been collected (for their specific research interest in ageing), how it was collected and how to gain access to the data.
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- 2021
13. Care plus study: a multi-site implementation of early palliative care in routine practice to improve health outcomes and reduce hospital admissions for people with advanced cancer: a study protocol
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Meinir Krishnasamy, Danny Rischin, Gregory B Crawford, Brian Le, Jennifer Philip, Sue-Anne McLachlan, Roslyn Le Gautier, Anna Collins, Vijaya Sundararajan, Geoff Mitchell, Maarten Joost IJzerman, Anna K. Nowak, Tanara Vieira Sousa, Robyn Hudson, and Nicole Rankin
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Palliative care ,Referral ,Population health ,State Medicine ,Health administration ,03 medical and health sciences ,Study Protocol ,0302 clinical medicine ,Nursing ,Neoplasms ,Health care ,Outcome Assessment, Health Care ,Medicine ,Humans ,030212 general & internal medicine ,Uncategorized ,business.industry ,Health Policy ,Nursing research ,Australia ,Integrated care ,Hospitals ,Health services ,Hospitalization ,030220 oncology & carcinogenesis ,Implementation ,Public aspects of medicine ,RA1-1270 ,business ,End-of-life care - Abstract
Background Current international consensus is that ‘early’ referral to palliative care services improves cancer patient and family carer outcomes. In practice, however, these referrals are not routine. An approach which directly addresses identified barriers to early integration of palliative care is required. This protocol details a trial of a standardized model of early palliative care (Care Plus) introduced at key defined, disease-specific times or transition points in the illness for people with cancer. Introduced as a ‘whole of system’ practice change for identified advanced cancers, the key outcomes of interest are population health service use change. The aims of the study are to examine the effect of Care Plus implementation on (1) acute hospitalisation days in the last 3 months of life; (2) timeliness of access to palliative care; (3) quality and (4) costs of end of life care; and (5) the acceptability of services for people with advanced cancer. Methods Multi-site stepped wedge implementation trial testing usual care (control) versus Care Plus (practice change). The design stipulates ‘control’ periods when usual care is observed, and the process of implementing Care Plus which includes phases of planning, engagement, practice change and evaluation. During the practice change phase, all patients with targeted advanced cancers reaching the transition point will, by default, receive Care Plus. Health service utilization and unit costs before and after implementation will be collated from hospital records, and state and national health service administrative datasets. Qualitative data from patients, consumers and clinicians before and after practice change will be gathered through interviews and focus groups. Discussion The study outcomes will detail the impact and acceptability of the standardized integration of palliative care as a practice change, including recommendations for ongoing sustainability and broader implementation. Trial registration Australian New Zealand Clinical Trials Registry ACTRN 12619001703190. Registered 04 December 2019.
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- 2021
14. Demographic and clinical profile of residents living with dementia and depressive symptoms in Australian private residential aged care: Data from the Music Interventions for Dementia and Depression in ELderly care ( <scp>MIDDEL</scp> ) cluster‐randomised controlled trial
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Young‐Eun C. Lee, Tanara Vieira Sousa, Phoebe A. Stretton‐Smith, Christian Gold, Monika Geretsegger, and Felicity A. Baker
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Community and Home Care ,General Medicine ,Geriatrics and Gerontology - Published
- 2022
15. ParkinSong Online: protocol for a telehealth feasibility study of therapeutic group singing for people with Parkinson's disease
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Jeanette Tamplin, Meg E Morris, Felicity A Baker, Tanara Vieira Sousa, Simon Haines, Stephen Dunn, Victoria Tull, and Adam P Vogel
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Neurology ,Parkinson's disease ,Quality of Life ,complementary medicine ,Feasibility Studies ,Humans ,Singing ,Parkinson Disease ,speech pathology ,General Medicine ,telemedicine - Abstract
IntroductionParkinson’s disease can be associated with speech deterioration and low communication confidence which in turn compromises social interaction. Therapeutic singing is an engaging method for combatting speech decline; however, face-to-face delivery can limit access to group singing. The aim of this study is to test the feasibility and acceptability of an online mode of delivery for a Parkinson’s singing intervention (ParkinSong) as well as remote data collection procedures.Methods and analysisThis ParkinSong Online feasibility trial is a single-arm, pre–post study of online singing delivery and remote data collection for 30 people living with Parkinson’s. The primary outcome measure is feasibility: recruitment, retention, attendance, safety, intervention fidelity, acceptability and associated costs. Secondary outcomes are speech (loudness, intelligibility, quality, communication-related quality of life) and wellbeing (apathy, depression, anxiety, stress, health-related quality of life). This mode of delivery aims to increase the accessibility of singing interventions.Ethics and disseminationEthics approval was obtained from The University of Melbourne Human Research Ethics Committee (2021-14465-16053-3) and the trial has been prospectively registered. Results will be presented at national and international conferences, published in a peer-reviewed journal, and disseminated to the Parkinson’s community, researchers and policymakers.Trial registration numberACTRN12621000940875.
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- 2021
16. Comparing health gains, costs and cost-effectiveness of 100s of interventions in Australia and New Zealand: an online interactive league table
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Natalie Carvalho, Tanara Vieira Sousa, Anja Mizdrak, Amanda Jones, Nick Wilson, and Tony Blakely
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Epidemiology ,Cost-Benefit Analysis ,Public Health, Environmental and Occupational Health ,Australia ,Humans ,Health Care Costs ,Quality-Adjusted Life Years ,health care economics and organizations ,New Zealand - Abstract
Background This study compares the health gains, costs, and cost-effectiveness of hundreds of Australian and New Zealand (NZ) health interventions conducted with comparable methods in an online interactive league table designed to inform policy. Methods A literature review was conducted to identify peer-reviewed evaluations (2010 to 2018) arising from the Australia Cost-Effectiveness research and NZ Burden of Disease Epidemiology, Equity and Cost-Effectiveness Programmes, or using similar methodology, with: health gains quantified as health-adjusted life years (HALYs); net health system costs and/or incremental cost-effectiveness ratio; time horizon of at least 10 years; and 3% to 5% discount rates. Results We identified 384 evaluations that met the inclusion criteria, covering 14 intervention domains: alcohol; cancer; cannabis; communicable disease; cardiovascular disease; diabetes; diet; injury; mental illness; other non-communicable diseases; overweight and obesity; physical inactivity; salt; and tobacco. There were large variations in health gain across evaluations: 33.9% gained less than 0.1 HALYs per 1000 people in the total population over the remainder of their lifespan, through to 13.0% gaining > 10 HALYs per 1000 people. Over a third (38.8%) of evaluations were cost-saving. Conclusions League tables of comparably conducted evaluations illustrate the large health gain (and cost) variations per capita between interventions, in addition to cost-effectiveness. Further work can test the utility of this league table with policy-makers and researchers.
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- 2021
17. Clinical effectiveness of music interventions for dementia and depression in elderly care (MIDDEL): Australian cohort of an international pragmatic cluster-randomised controlled trial
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Felicity A Baker, Young-Eun C Lee, Tanara Vieira Sousa, Phoebe A Stretton-Smith, Jeanette Tamplin, Vigdis Sveinsdottir, Monika Geretsegger, Jo Dugstad Wake, Jörg Assmus, and Christian Gold
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Health (social science) ,Depression ,Australia ,COVID-19 ,Psychiatry and Mental health ,Treatment Outcome ,Communicable Disease Control ,Humans ,Dementia ,Geriatrics and Gerontology ,Family Practice ,Music Therapy ,Music ,Aged - Abstract
Background Dementia and depression are highly prevalent and comorbid conditions among older adults living in care homes and are associated with individual distress and rising societal costs. Effective, scalable, and feasible interventions are needed. Music interventions have shown promising effects, but the current evidence base is inconclusive. The present study aimed to determine the effectiveness of two different music interventions on the depressive symptoms of people with dementia living in residential aged care. Methods We implemented a 2 × 2 factorial cluster-randomised controlled trial to determine whether group music therapy (GMT) is more effective than no GMT with standard care, or recreational choir singing (RCS) is more effective than no RCS with standard care, for reducing depressive symptoms and other secondary outcomes in people with dementia with mild to severe depressive symptoms living in residential aged care. Care home units with at least ten residents were allocated to GMT, RCS, GMT plus RCS, or standard care, using a computer-generated list with block randomisation (block size four). The protocolised interventions were delivered by music therapists (GMT) and community musicians (RCS). The primary outcome was Montgomery-Åsberg Depression Rating Scale score at 6 months, assessed by a masked assessor and analysed on an intention-to-treat basis using linear mixed-effects models, which examined the effects of GMT versus no-GMT and RCS versus no-RCS, as well as interaction effects of GMT and RCS. We report on the Australian cohort of an international trial. This trial is registered with ClinicalTrials.gov, NCT03496675, and anzctr.org.au, ACTRN12618000156280. Findings Between June 15, 2018, and Feb 18, 2020, we approached 12 RAC facilities with 26 eligible care home units and, excluding six units who could not be enrolled due to COVID-19 lockdowns, we screened 818 residents. Between July 18, 2018, and Nov 26, 2019, 20 care home units were randomised (318 residents). Recruitment ceased on March 17, 2020, due to COVID-19. The primary endpoint, available from 20 care home units (214 residents), suggested beneficial effects of RCS (mean difference –4·25, 95% CI –7·89 to –0·62; p=0·0221) but not GMT (mean difference –0·44, –4·32 to 3·43; p=0·8224). No related serious adverse events occurred. Interpretation Our study supports implementing recreational choir singing as a clinically relevant therapeutic intervention in reducing depressive symptoms for people with dementia in the Australian care home context. publishedVersion
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- 2021
18. Process and Resource Assessment in Trials Undertaken in Residential Care Homes: Experiences from the Australian MIDDEL Cluster Randomised Controlled Trial Research Team
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Felicity Anne Baker, Phoebe Stretton-Smith, Tanara Vieira Sousa, Imogen Clark, Alice Cotton, Christian Gold, and Young-Eun Claire Lee
- Abstract
Background: The resources involved in delivering a clinical trial in residential aged care facilities (RACFs) are significant and the success of a trial is dependent upon adequate planning, including appropriate timelines for each component of the study and the required budget. The main aim of this paper is to describe process and resource assessment during recruitment, collection of outcome measures and intervention delivery and present learnings and considerations for conducting trials in RACFs with people living with dementia. Methods: We collected data across 24 clusters in 12 RACFs over 18 months during a cluster randomised controlled trial which was testing the effectiveness of music interventions in people living with dementia. Data were collected on resources required for recruitment and assessment of baseline data, as well as data on reasons for participant non-attendance at the interventions. Results: Results show that time between contacting next of kin and receiving formal consent often exceeded 45 days and the ratio of time between direct and indirect research activity is approximately 1:2. Participant intervention adherence is at risk from unplanned RACF lockdowns and reasons for non-attendance include those both related directly to the participant and to staff resources, scheduling or other practical considerations. Conclusions: Researchers planning studies within RACFs should focus on building relationships with RACF staff and resident families, factor in adequate time for recruitment in the study timeline and consider budgeting for backfill of RACF staff during data collection phases to expedite the process and ensure adherence to study protocol timelines. This study provides specific data on resource assessment and intervention adherence that could be beneficial for future researchers planning to conduct trials in RACFs with people with dementia. Trial registration: Australian and New Zealand Clinical Trial Registry: ANZCTR12618000156280, 1/02/2018, http://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12618000156280
- Published
- 2020
19. HOMESIDE: Home-based family caregiver-delivered music and reading interventions for people living with dementia: Protocol of a randomised controlled trial
- Author
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Jodie Bloska, Tanara Vieira Sousa, Young-Eun C Lee, Imogen N. Clark, Nicola T. Lautenschlager, Ming H Hsu, Felicity A. Baker, Sabine Braat, Thomas Wosch, Tone Kvamme, Agnieszka Smrokowska-Reichmann, Jeanette Tamplin, Anna A. Bukowska, Karette Stensæth, and Helen Odell-Miller
- Subjects
Gerontology ,caregivers ,Music therapy ,Home Nursing ,music therapy ,Geriatric Medicine ,Psychological intervention ,MEDLINE ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,Quality of life ,law ,Protocol ,home-based interventions ,Humans ,Multicenter Studies as Topic ,Medicine ,Dementia ,Family ,030212 general & internal medicine ,Competence (human resources) ,Randomized Controlled Trials as Topic ,business.industry ,General Medicine ,medicine.disease ,behavioural and psychological symptoms of dementia ,3. Good health ,Reading ,Quality of Life ,business ,randomised controlled trial ,030217 neurology & neurosurgery ,Neuropsychiatric Inventory Questionnaire - Abstract
IntroductionPharmacological interventions to address behavioural and psychological symptoms of dementia (BPSD) can have undesirable side effects, therefore non-pharmacological approaches to managing symptoms may be preferable. Past studies show that music therapy can reduce BPSD, and other studies have explored how formal caregivers use music in their caring roles. However, no randomised study has examined the effects on BPSD of music interventions delivered by informal caregivers (CGs) in the home setting. Our project aims to address the need for improved informal care by training cohabiting family CGs to implement music interventions that target BPSD, and the quality of life (QoL) and well-being of people with dementia (PwD) and CGs.Methods and analysisA large international three-arm parallel-group randomised controlled trial will recruit a sample of 495 dyads from Australia, Germany, UK, Poland and Norway. Dyads will be randomised equally to standard care (SC), a home-based music programme plus SC, or a home-based reading programme plus SC for 12 weeks. The primary outcome is BPSD of PwD (measured using the Neuropsychiatric Inventory-Questionnaire). Secondary outcomes will examine relationship quality between CG and PwD, depression, resilience, competence, QoL for CG and QoL for PwD. Outcomes will be collected at baseline, at the end of the 12-week intervention and at 6 months post randomisation. Resource Utilisation in Dementia will be used to collect economic data across the life of the intervention and at 6-month follow-up. We hypothesise that the music programme plus SC will generate better results than SC alone (primary comparison) and the reading programme plus SC (secondary comparison).Ethics and disseminationEthical approval has been obtained for all countries. Results will be presented at national and international conferences and published in scientific journals and disseminated to consumer and caregiver representatives and the community.Trial registration numbersACTRN12618001799246p; NCT03907748
- Published
- 2019
20. Resource assessment in trials undertaken in residential care homes: Experiences from the Australian MIDDEL cluster randomised controlled trial research team
- Author
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Imogen N. Clark, Felicity A. Baker, Tanara Vieira Sousa, Phoebe A. Stretton-Smith, Alice Cotton, Young-Eun C Lee, and Christian Gold
- Subjects
Music therapy ,Next of kin ,Psychological intervention ,Nursing homes ,Article ,Resource assessment ,03 medical and health sciences ,Residential aged care ,0302 clinical medicine ,Nursing ,Project management ,Medicine ,030212 general & internal medicine ,Cluster randomised controlled trial ,Pharmacology ,Protocol (science) ,lcsh:R5-920 ,Data collection ,business.industry ,Timeline ,General Medicine ,Clinical trial ,Intervention adherence ,Dementia ,Recruitment ,lcsh:Medicine (General) ,business ,030217 neurology & neurosurgery - Abstract
Background The resources involved in delivering a clinical trial in residential aged care facilities (RACFs) are significant and the success of a trial is dependent upon adequate planning, including appropriate timelines for each component of the study and the required budget. This paper describes process and resource assessment during recruitment, collection of outcome measures and intervention delivery, and presents learnings and considerations for conducting trials in RACFs with people living with dementia. Methods Data were collected across 24 clusters in 12 RACFs over 18 months during a cluster randomised controlled trial which was testing the effectiveness of music interventions in people living with dementia. Data were collected on resources required for recruitment and assessment of baseline data, as well as reasons for participant non-attendance at the interventions. Results Time between contacting next of kin and receiving formal consent often exceeded 45 days. The ratio of time between direct and indirect research activity was approximately 1:2. Participant intervention adherence is at risk from unplanned RACF lockdowns and reasons for non-attendance include those both related directly to the participant and to staff resources, scheduling or other practical considerations. Conclusions Research planning should focus on building relationships with RACF staff and resident families, factor in adequate time for recruitment in the study timeline and consider budgeting for backfill of RACF staff during data collection phases to expedite the process and ensure adherence to study protocol timelines. Trial registration Australian and New Zealand Clinical Trial Registry: ANZCTR12618000156280, 1/02/2018, http://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12618000156280 A
- Published
- 2020
21. Oral Fluid Testing for Cocaine: Analytical Evaluation of Two Point-of-Collection Drug Screening Devices
- Author
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Renata Pereira Limberger, Taís Regina Fiorentin, Flavio Pechansky, Tanara Vieira Sousa, and Juliana Nichterwitz Scherer
- Subjects
Drug ,Narcotics ,Drugs of abuse ,Health, Toxicology and Mutagenesis ,Point-of-care testing ,media_common.quotation_subject ,Poison control ,Toxicology ,Screen test ,01 natural sciences ,Gas Chromatography-Mass Spectrometry ,Analytical Chemistry ,03 medical and health sciences ,0302 clinical medicine ,Cocaine ,Environmental Chemistry ,Cutoff ,030216 legal & forensic medicine ,Saliva ,Reliability (statistics) ,media_common ,Chemical Health and Safety ,business.industry ,010401 analytical chemistry ,Reproducibility of Results ,0104 chemical sciences ,Substance Abuse Detection ,Oral fluid ,Nuclear medicine ,business - Abstract
The use of point-of-collection testing (POCT) devices for drugs of abuse in oral fluid (OF) is an advantageous tool that has been used for different purposes-particularly traffic enforcement. However, even with the widespread report of cocaine consumption, the reliability of POCT devices has been reported in different magnitudes. This study evaluated the reliability of two POCT devices for the detection of cocaine in OF samples of 110 cocaine users: (i) the DDS2™ (cutoff = 30 ng/mL) and (ii) the Multi-Drugs Multi-Line-Twist Screen Test Device™ (MDML) (cutoff = 20 ng/mL). Results of the screening tests were compared with a Liquid Chromatography-Mass Spectrometry (LC-MS) assay. Sensitivity, specificity and accuracy of DDS2™ were 100, 77.77 and 80% when compared with LC-MS with a cutoff of 30 ng/mL, and 88.89, 89.15 and 89.09% with a cutoff of 10 ng/mL. The MDML™ device achieved sensitivity, specificity and accuracy of 100, 65.6 and 70.9% when compared with LC-MS with a cutoff of 20 ng/mL, and 92.6, 71.1 and 76.6% with a cutoff of 10 ng/mL. When compared with a 10 ng/mL cutoff, the DDS2™ achieved reliability parameters higher than 80%. On the other hand, the MDML™ device did not achieve the minimal recommendation of 80% for all parameters at the same time. Taking into consideration the reliability results showed here, the authors believe that the use of these POCT devices seems to be suitable for cocaine detection in forensic tests only if all positive specimens are further confirmed by a validated method.
- Published
- 2016
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