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2. A pragmatic randomised controlled trial of the Welsh National Exercise Referral Scheme: protocol for trial and integrated economic and process evaluation

Author

Hale Janine, Ud Din Nafees, Williams Nefyn, Linck Pat, Edwards Rhiannon, Moore Graham, Raisanen Larry, Murphy Simon, Roberts Chris, McNaish Elaine, and Moore Laurence

Subjects
Public aspects of medicine, RA1-1270
Abstract

Abstract Background The benefits to health of a physically active lifestyle are well established and there is evidence that a sedentary lifestyle plays a significant role in the onset and progression of chronic disease. Despite a recognised need for effective public health interventions encouraging sedentary people with a medical condition to become more active, there are few rigorous evaluations of their effectiveness. Following NICE guidance, the Welsh national exercise referral scheme was implemented within the context of a pragmatic randomised controlled trial. Methods/Design The randomised controlled trial, with nested economic and process evaluations, recruited 2,104 inactive men and women aged 16+ with coronary heart disease (CHD) risk factors and/or mild to moderate depression, anxiety or stress. Participants were recruited from 12 local health boards in Wales and referred directly by health professionals working in a range of health care settings. Consenting participants were randomised to either a 16 week tailored exercise programme run by qualified exercise professionals at community sports centres (intervention), or received an information booklet on physical activity (control). A range of validated measures assessing physical activity, mental health, psycho-social processes and health economics were administered at 6 and 12 months, with the primary 12 month outcome measure being 7 day Physical Activity Recall. The process evaluation explored factors determining the effectiveness or otherwise of the scheme, whilst the economic evaluation determined the relative cost-effectiveness of the scheme in terms of public spending. Discussion Evaluation of such a large scale national public health intervention presents methodological challenges in terms of trial design and implementation. This study was facilitated by early collaboration with social research and policy colleagues to develop a rigorous design which included an innovative approach to patient referral and trial recruitment, a comprehensive process evaluation examining intervention delivery and an integrated economic evaluation. This will allow a unique insight into the feasibility, effectiveness and cost effectiveness of a national exercise referral scheme for participants with CHD risk factors or mild to moderate anxiety, depression, or stress and provides a potential model for future policy evaluations. Trial registration Current Controlled Trials ISRCTN47680448

Published
2010
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3. Mixed methods process evaluation of an enhanced community-based rehabilitation intervention for elderly patients with hip fracture.

Author

Roberts, Jessica Louise, Pritchard, Aaron W., Williams, Michelle, Totton, Nikki, Morrison, Val, Ud Din, Nafees, and Williams, Nefyn H.

Abstract

Objectives To describe the implementation of an enhanced rehabilitation programme for elderly hip fracture patients with mental capacity, in a randomised feasibility study compared with usual rehabilitation. To compare processes between the two and to collect the views of patients, carers and therapy staff about trial participation. Design Mixed methods process evaluation in a randomised feasibility study. Setting Patient participants were recruited on orthopaedic and rehabilitation wards; the intervention was delivered in the community following hospital discharge. Participants Sixty-one older adults (aged =65 years) recovering from surgical treatment (replacement arthroplasty or internal fixation) following hip fracture, who were living independently prior to fracture and had mental capacity and 31 of their carers. Interventions Usual care (control) or usual care plus an enhanced rehabilitation package (intervention). The enhanced rehabilitation consisted of a patient-held information workbook, goal-setting diary and up to six additional therapy sessions. Process evaluation components Recruitment of sites and rehabilitation teams, response of rehabilitation teams, recruitment and reach in patient and carer participants, intervention delivery, delivery to individuals, response of individual patients to the enhanced intervention or usual rehabilitation, response of carer participants, unintended consequences and testing intervention theory and context. Results Usual rehabilitation care was very variable. The enhanced rehabilitation group received a mean of five additional therapy sessions. All of the returned goalsetting diaries had inputs from the therapy team, and half had written comments by the patients and carers. Focus group themes: variation of usual care and its impact on delivering the intervention; the importance of goal setting; the role of the therapist in providing reassurance about safe physical activities; and acceptability of the extra therapy sessions. Conclusions Lessons learnt for a future definitive RCT include how to enhance recruitment and improve training materials, the workbook, delivery of the extra therapy sessions and recording of usual rehabilitation care. [ABSTRACT FROM AUTHOR]

Published
2018
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5. A pragmatic randomised controlled trial of the Welsh National Exercise Referral Scheme: protocol for trial and integrated economic and process evaluation

Author

Murphy, Simon, primary, Raisanen, Larry, additional, Moore, Graham, additional, Edwards, Rhiannon Tudor, additional, Linck, Pat, additional, Williams, Nefyn, additional, Ud Din, Nafees, additional, Hale, Janine, additional, Roberts, Chris, additional, McNaish, Elaine, additional, and Moore, Laurence, additional

Published
2010
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6. Mixed-method process evaluation of the Welsh National Exercise Referral Scheme.

Author

Moore, Graham F., Raisanen, Lawrence, Moore, Laurence, Ud Din, Nafees, and Murphy, Simon

Subjects
EXERCISE & psychology, EXERCISE, HEALTH behavior, HEALTH promotion, INTERVIEWING, RESEARCH methodology, SCIENTIFIC observation, HEALTH outcome assessment, PATIENT compliance, PATIENT education, PRIMARY health care, QUESTIONNAIRES, RESEARCH funding, SELF-perception, LOGISTIC regression analysis, RANDOMIZED controlled trials, EVALUATION of human services programs, DATA analysis software, PATIENTS' attitudes
Abstract

Purpose - Primary-care referral to community-based exercise specialists (exercise referral) is common in the UK despite limited evidence of effectiveness. A recent pragmatic randomised trial of the Welsh National Exercise Referral Scheme (NERS), demonstrated promising impacts upon physical activity and mental health. This paper presents a mixed-method process evaluation exploring how outcomes were achieved. Design/methodology/approach - Structured observation, implementer interviews and routine data assessed the extent to which NERS was implemented as intended. Baseline trial data were combined with routine monitoring data for the purposes of profiling uptake and adherence. Semistructured patient interviews explored processes of change and the emergence of social patterning in responses to the scheme. Findings - NERS offered patients a programme of supervised, group-based discounted exercise. However, motivational interviewing, goal-setting and patient follow-up protocols were delivered poorly. The high degree of professional support was perceived as helping patients to build confidence and assimilate into exercise environments. Patient-only classes provided social contacts, a supportive context and realistic models. Patterning in uptake emerged from access issues, with uptake lower among non-car owners. Adherence was poorer among mental health patients, younger patients and those who were least active prior to referral to NERS. Originality/value - In practice, although the NERS RCT demonstrated positive impacts on physical activity and mental health, process evaluation data indicate that the intervention was not entirely delivered as intended. Mixed-method process evaluation served crucial functions in understanding implementation and functioning, offering insights into the roles of professional support and exercise classes in promoting activity and mental health, and the emergence of social patterning in responses to an ERS. [ABSTRACT FROM AUTHOR]

Published
2013
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7. Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR): study protocol for a phase II randomised feasibility study of a multidisciplinary rehabilitation package following hip fracture

Author

Williams, Nefyn H., Roberts, Jessica L., Ud Din, Nafees, Totton, Nicola, Charles, Joanna M., Hawkes, Claire A., Morrison, Val, Zoe, Hoare, Williams, Michelle, Pritchard, Aaron W., Alexander, Swapna, Lemmey, Andrew, Woods, Robert T., Sackley, Catherine Mary, Logan, Phillipa A., Edwards, Rhiannon T., Wilkinson, Clare, Williams, Nefyn H., Roberts, Jessica L., Ud Din, Nafees, Totton, Nicola, Charles, Joanna M., Hawkes, Claire A., Morrison, Val, Zoe, Hoare, Williams, Michelle, Pritchard, Aaron W., Alexander, Swapna, Lemmey, Andrew, Woods, Robert T., Sackley, Catherine Mary, Logan, Phillipa A., Edwards, Rhiannon T., and Wilkinson, Clare

Abstract

Objective: To conduct a rigorous feasibility study for a future definitive parallel-group randomised controlled trial (RCT) and economic evaluation of an enhanced rehabilitation package for hip fracture. Setting: Recruitment from 3 acute hospitals in North Wales. Intervention delivery in the community. Participants: Older adults (aged ≥65) who received surgical treatment for hip fracture, lived independently prior to fracture, had mental capacity (assessed by clinical team) and received rehabilitation in the North Wales area. Intervention: Remote randomisation to usual care (control) or usual care+enhanced rehabilitation package (intervention), including six additional home-based physiotherapy sessions delivered by a physiotherapist or technical instructor, novel information workbook and goal-setting diary. Primary and secondary outcome measures: Primary: Barthel Activities of Daily Living (BADL). Secondary measures included Nottingham Extended Activities of Daily Living scale (NEADL), EQ-5D, ICECAP capability, a suite of self-efficacy, psychosocial and service-use measures and costs. Outcome measures were assessed at baseline and 3-month follow-up by blinded researchers. Results: 62 participants were recruited, 61 randomised (control 32; intervention 29) and 49 (79%) completed 3-month follow-up. Minimal differences occurred between the 2 groups for most outcomes, including BADL (adjusted mean difference 0.5). The intervention group showed a medium-sized improvement in the NEADL relative to the control group, with an adjusted mean difference between groups of 3.0 (Cohen's d 0.63), and a trend for greater improvement in self-efficacy and mental health, but with small effect sizes. The mean cost of delivering the intervention was £231 per patient. There was a small relative improvement in quality-adjusted life year in the intervention group. No serious adverse events relating to the intervention were reported. Conclusions: The trial methods were feasible in terms of e

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8. Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR): study protocol for a phase II randomised feasibility study of a multidisciplinary rehabilitation package following hip fracture

Author

Williams, Nefyn H., Roberts, Jessica L., Ud Din, Nafees, Totton, Nicola, Charles, Joanna M., Hawkes, Claire A., Morrison, Val, Zoe, Hoare, Williams, Michelle, Pritchard, Aaron W., Alexander, Swapna, Lemmey, Andrew, Woods, Robert T., Sackley, Catherine Mary, Logan, Phillipa A., Edwards, Rhiannon T., Wilkinson, Clare, Williams, Nefyn H., Roberts, Jessica L., Ud Din, Nafees, Totton, Nicola, Charles, Joanna M., Hawkes, Claire A., Morrison, Val, Zoe, Hoare, Williams, Michelle, Pritchard, Aaron W., Alexander, Swapna, Lemmey, Andrew, Woods, Robert T., Sackley, Catherine Mary, Logan, Phillipa A., Edwards, Rhiannon T., and Wilkinson, Clare

Abstract

Objective: To conduct a rigorous feasibility study for a future definitive parallel-group randomised controlled trial (RCT) and economic evaluation of an enhanced rehabilitation package for hip fracture. Setting: Recruitment from 3 acute hospitals in North Wales. Intervention delivery in the community. Participants: Older adults (aged ≥65) who received surgical treatment for hip fracture, lived independently prior to fracture, had mental capacity (assessed by clinical team) and received rehabilitation in the North Wales area. Intervention: Remote randomisation to usual care (control) or usual care+enhanced rehabilitation package (intervention), including six additional home-based physiotherapy sessions delivered by a physiotherapist or technical instructor, novel information workbook and goal-setting diary. Primary and secondary outcome measures: Primary: Barthel Activities of Daily Living (BADL). Secondary measures included Nottingham Extended Activities of Daily Living scale (NEADL), EQ-5D, ICECAP capability, a suite of self-efficacy, psychosocial and service-use measures and costs. Outcome measures were assessed at baseline and 3-month follow-up by blinded researchers. Results: 62 participants were recruited, 61 randomised (control 32; intervention 29) and 49 (79%) completed 3-month follow-up. Minimal differences occurred between the 2 groups for most outcomes, including BADL (adjusted mean difference 0.5). The intervention group showed a medium-sized improvement in the NEADL relative to the control group, with an adjusted mean difference between groups of 3.0 (Cohen's d 0.63), and a trend for greater improvement in self-efficacy and mental health, but with small effect sizes. The mean cost of delivering the intervention was £231 per patient. There was a small relative improvement in quality-adjusted life year in the intervention group. No serious adverse events relating to the intervention were reported. Conclusions: The trial methods were feasible in terms of e

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9. Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR): study protocol for a phase II randomised feasibility study of a multidisciplinary rehabilitation package following hip fracture

Author

Williams, Nefyn H., Roberts, Jessica L., Ud Din, Nafees, Totton, Nicola, Charles, Joanna M., Hawkes, Claire A., Morrison, Val, Zoe, Hoare, Williams, Michelle, Pritchard, Aaron W., Alexander, Swapna, Lemmey, Andrew, Woods, Robert T., Sackley, Catherine Mary, Logan, Phillipa A., Edwards, Rhiannon T., Wilkinson, Clare, Williams, Nefyn H., Roberts, Jessica L., Ud Din, Nafees, Totton, Nicola, Charles, Joanna M., Hawkes, Claire A., Morrison, Val, Zoe, Hoare, Williams, Michelle, Pritchard, Aaron W., Alexander, Swapna, Lemmey, Andrew, Woods, Robert T., Sackley, Catherine Mary, Logan, Phillipa A., Edwards, Rhiannon T., and Wilkinson, Clare

Abstract

Objective: To conduct a rigorous feasibility study for a future definitive parallel-group randomised controlled trial (RCT) and economic evaluation of an enhanced rehabilitation package for hip fracture. Setting: Recruitment from 3 acute hospitals in North Wales. Intervention delivery in the community. Participants: Older adults (aged ≥65) who received surgical treatment for hip fracture, lived independently prior to fracture, had mental capacity (assessed by clinical team) and received rehabilitation in the North Wales area. Intervention: Remote randomisation to usual care (control) or usual care+enhanced rehabilitation package (intervention), including six additional home-based physiotherapy sessions delivered by a physiotherapist or technical instructor, novel information workbook and goal-setting diary. Primary and secondary outcome measures: Primary: Barthel Activities of Daily Living (BADL). Secondary measures included Nottingham Extended Activities of Daily Living scale (NEADL), EQ-5D, ICECAP capability, a suite of self-efficacy, psychosocial and service-use measures and costs. Outcome measures were assessed at baseline and 3-month follow-up by blinded researchers. Results: 62 participants were recruited, 61 randomised (control 32; intervention 29) and 49 (79%) completed 3-month follow-up. Minimal differences occurred between the 2 groups for most outcomes, including BADL (adjusted mean difference 0.5). The intervention group showed a medium-sized improvement in the NEADL relative to the control group, with an adjusted mean difference between groups of 3.0 (Cohen's d 0.63), and a trend for greater improvement in self-efficacy and mental health, but with small effect sizes. The mean cost of delivering the intervention was £231 per patient. There was a small relative improvement in quality-adjusted life year in the intervention group. No serious adverse events relating to the intervention were reported. Conclusions: The trial methods were feasible in terms of e

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10. Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR): study protocol for a phase II randomised feasibility study of a multidisciplinary rehabilitation package following hip fracture

Author

Williams, Nefyn H., Roberts, Jessica L., Ud Din, Nafees, Totton, Nicola, Charles, Joanna M., Hawkes, Claire A., Morrison, Val, Zoe, Hoare, Williams, Michelle, Pritchard, Aaron W., Alexander, Swapna, Lemmey, Andrew, Woods, Robert T., Sackley, Catherine Mary, Logan, Phillipa A., Edwards, Rhiannon T., Wilkinson, Clare, Williams, Nefyn H., Roberts, Jessica L., Ud Din, Nafees, Totton, Nicola, Charles, Joanna M., Hawkes, Claire A., Morrison, Val, Zoe, Hoare, Williams, Michelle, Pritchard, Aaron W., Alexander, Swapna, Lemmey, Andrew, Woods, Robert T., Sackley, Catherine Mary, Logan, Phillipa A., Edwards, Rhiannon T., and Wilkinson, Clare

Abstract

Objective: To conduct a rigorous feasibility study for a future definitive parallel-group randomised controlled trial (RCT) and economic evaluation of an enhanced rehabilitation package for hip fracture. Setting: Recruitment from 3 acute hospitals in North Wales. Intervention delivery in the community. Participants: Older adults (aged ≥65) who received surgical treatment for hip fracture, lived independently prior to fracture, had mental capacity (assessed by clinical team) and received rehabilitation in the North Wales area. Intervention: Remote randomisation to usual care (control) or usual care+enhanced rehabilitation package (intervention), including six additional home-based physiotherapy sessions delivered by a physiotherapist or technical instructor, novel information workbook and goal-setting diary. Primary and secondary outcome measures: Primary: Barthel Activities of Daily Living (BADL). Secondary measures included Nottingham Extended Activities of Daily Living scale (NEADL), EQ-5D, ICECAP capability, a suite of self-efficacy, psychosocial and service-use measures and costs. Outcome measures were assessed at baseline and 3-month follow-up by blinded researchers. Results: 62 participants were recruited, 61 randomised (control 32; intervention 29) and 49 (79%) completed 3-month follow-up. Minimal differences occurred between the 2 groups for most outcomes, including BADL (adjusted mean difference 0.5). The intervention group showed a medium-sized improvement in the NEADL relative to the control group, with an adjusted mean difference between groups of 3.0 (Cohen's d 0.63), and a trend for greater improvement in self-efficacy and mental health, but with small effect sizes. The mean cost of delivering the intervention was £231 per patient. There was a small relative improvement in quality-adjusted life year in the intervention group. No serious adverse events relating to the intervention were reported. Conclusions: The trial methods were feasible in terms of e

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