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Introduction: Postoperative patients with ostomies experience significant changes in their lives as a result of the device implantation. Self-care is important to improve their health outcomes. Telehealth provides an opportunity to expand access to self-care education. Aim: This is a multicenter, non-inferiority randomized, open-label, controlled trial to evaluate the non-inferiority of a telehealth intervention to the standard in-person approach in improving self-care behaviors. Methods and analysis: Three hundred and eighty-four patients aged ≥ 18 years, with a recently placed ostomy, no stomal/peristomal complications, and documented cognitive integrity will be randomly assigned (1:1) to receive either a telehealth intervention (four remote educational sessions) or a standard educational approach (four in-person sessions) delivered in outpatient settings. Every session (remote and in-person) will occur on Days 25, 32, 40, and 60 after discharge. Follow-ups will occur 1, 3, and 6 months after the last intervention session. Primary outcome is self-care maintenance measured using the Ostomy Self-care Index (OSCI). Secondary outcomes include self-care monitoring, self-care management, self-efficacy (OSCI), quality of life (Stoma specific quality of Life), depression (Patient Health Questionnaire-9), adjustment (Ostomy Adjustment Inventory-23), stomal and peristomal complication rates, healthcare services utilization, mobility, and number of working days lost. Analyses will be performed per intention-to-treat and per protocol. Ethics and dissemination: This study has been approved by the Institutional Review Board of the main center (registration number: 119/22). Following completion of the trial, dissemination meetings will be held to share the results of the study with the participants and the health-care team. Adoption of telehealth technologies for ostomy patients can improve service organization by ensuring better integration and continuity of care. If the remote intervention produces comparable effects to the in-person intervention, it would be wise to make telehealth education an alternative treatment for addressing the educational needs of uncomplicated postoperative ostomy patients. Trial registration: ClinicalTrials.gov (identifier number: NCT05796544). [ABSTRACT FROM AUTHOR]

Aim: Patients with heart failure experience multiple co-occurring symptoms that lower their quality of life and increase hospitalization and mortality rates. So far, no heart failure symptom cluster study recruited patients from community settings or focused on symptoms predicting most clinical outcomes. Considering physical and psychological symptoms together allows understanding how they burden patients in different combinations. Moreover, studies predicting symptom cluster membership using variables other than symptoms are lacking. We aimed to (a) cluster heart failure patients based on physical and psychological symptoms and (b) predict symptom cluster membership using sociodemographic/clinical variables. Design: Secondary analysis of MOTIVATE-HF trial, which recruited 510 heart failure patients from a hospital, an outpatient and a community setting in Italy. Methods: Cluster analysis was performed based on the two scores of the Hospital Anxiety-Depression scale and two scores of the Heart-Failure Somatic Perception Scale predicting most clinical outcomes. ANOVA and chi-square test were used to compare patients' characteristics among clusters. For the predictive analysis, we split the data into a training set and a test set and trained three classification models on the former to predict patients' symptom cluster membership based on 11 clinical/ sociodemographic variables. Permutation analysis investigated which variables best predicted cluster membership. Results: Four clusters were identified based on the intensity and combination of psychological and physical symptoms: mixed distress (high psychological, low physical symptoms), high distress, low distress and moderate distress. Clinical and sociodemographic differences were found among clusters. NYHA-class (New York Heart Association) and sleep quality were the most important variables in predicting symptom cluster membership. Conclusions: These results can support the development of tailored symptom management intervention and the investigation of symptom clusters' effect on patient outcomes. The promising results of the predictive analysis suggest that such benefits may be obtained even when direct access to symptoms-related data is absent. Implications: These results may be particularly useful to clinicians, patients and researchers because they highlight the importance of addressing clusters of symptoms, instead of individual symptoms, to facilitate symptom detection and management. Knowing which variables best predict symptom cluster membership can allow to obtain such benefits even when direct access to symptoms-data is absent. Impact: Four clusters of heart failure patients characterized by different intensity and combination of psychological and physical symptoms were identified. NYHA class and sleep quality appeared important variables in predicting symptom cluster membership. Reporting Method: The authors have adhered to the EQUATOR guidelines STROBE to report observational cross-sectional studies. [ABSTRACT FROM AUTHOR]

Introduction: The COVID-19 pandemic has had a considerable impact on the psychological and psychopathological status of the population and health care workers in terms of insomnia, anxiety, depression, and post-traumatic stress disorder. The primary aim of this study was to describe and evaluate the impact of the pandemic on insomnia levels of a cohort of Italian nurses, particularly those involved in the care of COVID-19 patients. The secondary aim was to identify the interaction between insomnia and hardiness, anxiety, and sleep disturbances. Materials and Methods: A descriptive–exploratory study was conducted using an online survey during the first wave of the COVID-19 pandemic (March to July 2020). The questionnaire consisted of multiple-choice, open-ended, closed, and semi-closed questions. The psychometric tools administered were the Dispositional Resilience Scale (DRS-15), the State–Trait Anxiety Inventory (STAI-Y), and the Insomnia Severity Index (ISI). Results: a cohort of 1167 nurses fully completed the questionnaire (86.2% of total respondents). The insomnia scale survey showed an increase in post-pandemic scores compared to those before the pandemic, implying that insomnia levels increased after the first pandemic wave. Insomnia scores were directly correlated with anxiety levels (r = 0.571; p ≤ 0.05) and inversely correlated with hardiness levels (r = −0.324; p < 0.001). Multivariate analysis revealed the following protective factors: not having worked in COVID-19 wards, high levels of hardiness (commitment), and the presence of high pre-pandemic insomnia disorder. The main risk factor for insomnia reported in the analysis was a high anxiety score. Discussion and Conclusion: Anxiety represented the main risk factor for insomnia severity in our sample, while hardiness was confirmed as a protective factor. Thus, it is necessary to design further studies to identify additional risk factors for poor sleep quality and to develop educational courses and strategies aimed at enhancing rest and sleep quality, especially for frontline nurses. [ABSTRACT FROM AUTHOR]

Aims: The aim of the study was to develop and psychometrically test the Nurse–Patient Mutuality in Chronic Illness (NPM‐CI) scale in two versions, one for nurses and one for patients. Method: A multiphase methodological study was conducted. In the first phase, a qualitative investigation was conducted through interviews and an analysis of the content; inductively, the items of two instruments were generated, one for nurses and one for patients. In the second phase, the content and face validity were assessed through the expert consensus method. In the third phase, exploratory factor analysis (EFA), Cronbach's alpha test, intraclass correlation and Pearson correlation coefficients were conducted to estimate construct, criterion validity and instrument reliability. For each phase, the sample included nurses and patients recruited from a large hospital in Northern Italy. Data collection was conducted between June and September 2021. Results: Nurse and patient versions of the NPM‐CI scale were developed. Two rounds of consensus reduced the items from 39 to 20; content validity index ranged between 0.78 and 1, content validity ratio was 0.94. Face validity indicated clarity and comprehensibility of the items. EFA identified three latent factors for both the scales. Internal consistency was satisfactory, with Cronbach's alphas ranging between.80 and.90. Test–retest stability was suggested, with an intraclass correlation coefficient of.96 (nurse scale) and.97 (patient scale). Predictive validity was established, with a Pearson correlation coefficient of.43 (nurse scale) and 0.55 (patient scale) between the mutuality scales and satisfaction in providing and receiving care. Conclusion: The results suggest that the NPM‐CI scales are sufficiently valid and reliable for the clinical practice among chronic illness patients and the nurses caring for them. A more in‐depth exploration of this construct in the context of nursing and patient outcomes is warranted. Patient or Public Contribution: Patients were involved in all study phases. Impact: Mutuality is fundamental in the relationship between nurse and patient, based on trust, equality, reciprocity, and mutual respect. The NPM‐CI scale was developed and psychometric estimated through a multiphase study in both nurse and patient versions. The NPM‐CI scale measures the factors of 'developing and going beyond', 'being the point of reference' and 'deciding and sharing care'. The NPM‐CI scale allows us to measure mutuality in clinical practice and research. Expected outcomes and influencing factors for patients and nurses could be associated. [ABSTRACT FROM AUTHOR]

Objectives: Family is a major source of support for older chronically-ill patients and known to be associated with better self-care. Depression and self-care self-efficacy are associated with healthy behaviors and thus may serve as mechanisms by which family support influences self-care. We explored depression and self-care self-efficacy as mediators of the relationship between perceived family support and self-care. Methods: Five hundred forty-one older adults with multiple chronic illnesses were recruited from outpatients and community settings. Three structural equation models (SEM) were fit on cross-sectional data. We measured perceived family support (subscale of the Multidimensional Scale of Perceived Social Support, scores range 1-7), depression (Patient Health Questionnaire, scores range 0-27), selfcare self-efficacy (Self-Care Self Efficacy Scale, standardized scores range 0-100), and self-care maintenance, monitoring, and management (Self-care of Chronic Illness Inventory, standardized scores range 0-100). Results: Participants (mean age = 76.6±7.3 yrs) were predominantly females (55.6%). In the full sample, depression and self-care self-efficacy mediated the relationship between perceived family support and self-care; in the gender-stratified SEM, men's depression was no longer a significant mediator. Depression and self-care self-efficacy were significant mediators of the relation between perceived family support and self-care. Conclusion: In older chronically-ill patients, interventions addressing perceived family support may facilitate a rapid improvement in self-care self-efficacy and a decrease in depressive symptoms, particularly among women. [ABSTRACT FROM AUTHOR]

In patients with heart failure (HF), self‐care, and caregiver contribution to self‐care (i.e., the daily management of the disease by patients and caregivers) are essential for improving patient outcomes. However, patients and caregivers are often inadequate in their self‐care and contribution to self‐care, respectively, and struggle to perform related tasks. Face‐to‐face motivational interviewing (MI) effectively improves self‐care and caregiver contribution to self‐care, but the evidence on remote MI is scarce and inconclusive. The aims of this randomized controlled trial will be to evaluate whether remote MI performed via video call in patients with HF: (1) is effective at improving self‐care maintenance in patients (primary outcome); (2) is effective for the following secondary outcomes: (a) for patients: self‐care management, self‐care monitoring, and self‐efficacy; HF symptoms; generic and disease‐specific quality of life; anxiety and depression; use of healthcare services; and mortality; and (b) for caregivers: contribution to self‐care, self‐efficacy, and preparedness. We will conduct a two‐arm randomized controlled trial. We will enroll and randomize 432 dyads (patients and their informal caregivers) in Arm 1, in which patients and caregivers will receive MI or, in Arm 2, standard care. MI will be delivered seven times over 12 months. Outcomes will be assessed at baseline and 3 (primary outcome), 6, 9, and 12 months from enrollment. This trial will demonstrate whether an inexpensive and easily deliverable intervention can improve important HF outcomes. With the restrictions on in‐person healthcare professional interventions imposed by the COVID‐19 pandemic, it is essential to evaluate whether MI is also effective remotely. [ABSTRACT FROM AUTHOR]

Aims Provide an overview of remote motivational interviewing (MI) interventions for chronically ill patients, and understand their degree of effectiveness on different health outcomes. Methods and results A systematic review with meta-analysis was conducted using the following databases: PubMed, CINAHL, PsychInfo, and Web of Science. Eligibility criteria included studies that administered remote MI alone or in combination with other remote approaches. A narrative synthesis and two meta-analyses were performed. Fifteen studies met the inclusion criteria. MI administration almost exclusively occurred by telephone and individual sessions. Eight studies reported treatment fidelity aspects, and four declared adopting a theoretical framework. Most targeted outcomes were therapeutic adherence, physical activity, depression, quality of life, and mortality. Risk of bias varied markedly, with the largest source resulting from selection process and intervention performance. The two meta-analyses indicated a significant effect of MI on depression [standardized mean difference = –0.20, 95% confidence interval (CI): –0.34, –0.05, Z = 2.73, P = 0.006, I 2 = 0%], and no effect of MI on glycosylated haemoglobin (mean difference = –0.02, 95% CI: –0.48, 0.45, P = 0.94, I 2 = 84%). Conclusion Remote MI can be a promising approach for improving depression in chronic disease patients. However, studies are inconclusive due to risks of bias, heterogeneity, and lack of reporting of interventionist's training, treatment fidelity, and theoretical frameworks' use. More studies with solid designs are needed to inform clinical decision-making and research. Registration PROSPERO: CRD42021241516. [ABSTRACT FROM AUTHOR]