Dataset Information

Effectiveness of an eHealth self-management tool for older adults with multimorbidity (KeepWell): protocol for a hybrid effectiveness-implementation randomised controlled trial.

ABSTRACT:

Introduction

In response to the burden of chronic disease among older adults, different chronic disease self-management tools have been created to optimise disease management. However, these seldom consider all aspects of disease management are not usually developed specifically for seniors or created for sustained use and are primarily focused on a single disease. We created an eHealth self-management application called 'KeepWell' that supports seniors with complex care needs in their homes. It incorporates the care for two or more chronic conditions from among the most prevalent high-burden chronic diseases.

Methods and analysis

We will evaluate the effectiveness, cost and uptake of KeepWell in a 6-month, pragmatic, hybrid effectiveness-implementation randomised controlled trial. Older adults age ?65 years with one or more chronic conditions who are English speaking are able to consent and have access to a computer or tablet device, internet and an email address will be eligible. All consenting participants will be randomly assigned to KeepWell or control. The allocation sequence will be determined using a random number generator.Primary outcome is perceived self-efficacy at 6 months. Secondary outcomes include quality of life, health background/status, lifestyle (nutrition, physical activity, caffeine, alcohol, smoking and bladder health), social engagement and connections, eHealth literacy; all collected via a Health Risk Questionnaire embedded within KeepWell (intervention) or a survey platform (control). Implementation outcomes will include reach, effectiveness, adoption, fidelity, implementation cost and sustainability.

Ethics and dissemination

Ethics approval has been received from the North York General Hospital Research and Ethics Board. The study is funded by the Canadian Institutes of Health Research and the Ontario Ministry of Health. We will work with our team to develop a dissemination strategy which will include publications, presentations, plain language summaries and an end-of-grant meeting.

Trial registration number

NCT04437238.

SUBMITTER: Kastner M

PROVIDER: S-EPMC7893667 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Publications

Effectiveness of an eHealth self-management tool for older adults with multimorbidity (KeepWell): protocol for a hybrid effectiveness-implementation randomised controlled trial.

Kastner Monika M Makarski Julie J Hayden Leigh L Hamid Jemila S JS Holroyd-Leduc Jayna J Twohig Margo M Macfarlane Charlie C Hynes Mary Trapani MT Prasaud Leela L Sklar Barb B Honsberger Joan J Wang Marilyn M Kramer Gloria G Hobden Gerry G Armson Heather H Ivers Noah N Leung Fok-Han FH Liu Barbara B Marr Sharon S Greiver Michelle M Desroches Sophie S Sibley Kathryn K Saunders Hailey H Isaranuwatchai Wanrudee W McArthur Eric E Harvey Sarah S Manawadu Kithara K Petricca Kadia K Straus Sharon E SE

BMJ open 20210217 2

<h4>Introduction</h4>In response to the burden of chronic disease among older adults, different chronic disease self-management tools have been created to optimise disease management. However, these seldom consider all aspects of disease management are not usually developed specifically for seniors or created for sustained use and are primarily focused on a single disease. We created an eHealth self-management application called 'KeepWell' that supports seniors with complex care needs in their h ...[more]

PMID: 33597147

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Project description:BackgroundWhile effectiveness outcomes of eHealth-facilitated integrated care models (eICMs) in transplant and oncological populations are promising, implementing and sustaining them in real-world settings remain challenging. Allogeneic stem cell transplant (alloSCT) patients could benefit from an eICM to enhance health outcomes. To combat health deterioration, integrating chronic illness management, including continuous symptom and health behaviour monitoring, can shorten reaction times. We will test the 1st-year post-alloSCT effectiveness and evaluate bundled implementation strategies to support the implementation of a newly developed and adapted eICM in allogeneic stem cell transplantation facilitated by eHealth (SMILe-ICM). SMILe-ICM has been designed by combining implementation, behavioural, and computer science methods. Adaptions were guided by FRAME and FRAME-IS. It consists of four modules: 1) monitoring & follow-up; 2) infection prevention; 3) physical activity; and 4) medication adherence, delivered via eHealth and a care coordinator (an Advanced Practice Nurse). The implementation was supported by contextually adapted implementation strategies (e.g., creating new clinical teams, informing local opinion leaders).MethodsUsing a hybrid effectiveness-implementation randomised controlled trial, we will include a consecutive sample of 80 adult alloSCT patients who were transplanted and followed by University Hospital Basel (Switzerland). Inclusion criteria are basic German proficiency; elementary computer literacy; internet access; and written informed consent. Patients will be excluded if their condition prevents the use of technology, or if they are followed up only at external centres. Patient-level (1:1) stratified randomisation into a usual care group and a SMILe-ICM group will take place 10 days pre-transplantation. To gauge the SMILe-ICM's effectiveness primary outcome (re-hospitalisation rate), secondary outcomes (healthcare utilization costs; length of inpatient re-hospitalizations, medication adherence; treatment and self-management burden; HRQoL; Graft-versus-Host Disease rate; survival; overall survival rate) and implementation outcomes (acceptability, appropriateness, feasibility, fidelity), we will use multi-method, multi-informant assessment (via questionnaires, interviews, electronic health record data, cost capture methods).DiscussionThe SMILe-ICM has major innovative potential for reengineering alloSCT follow-up care, particularly regarding short- and medium-term outcomes. Our dual focus on implementation and effectiveness will both inform optimization of the SMILe-ICM and provide insights regarding implementation strategies and pathway, understudied in eHealth-facilitated ICMs in chronically ill populations.Trial registrationClinicalTrials.gov. Identifier: NCT04789863 . Registered April 01, 2021.

Project description:IntroductionGout is increasing despite effective therapies to lower serum urate concentrations to 0.36 mmol/L or less, which, if sustained, significantly reduces acute attacks of gout. Adherence to urate-lowering therapy (ULT) is poor, with rates of less than 50% 1 year after initiation of ULT. Attempts to increase adherence in gout patients have been disappointing. We aim to evaluate the effectiveness of use of a personal, self-management, 'smartphone' application (app) to achieve target serum urate concentrations in people with gout. We hypothesise that personalised feedback of serum urate concentrations will improve adherence to ULT.Methods and analysisSetting and designPrimary care. A prospective, cluster randomised (by general practitioner (GP) practices), controlled trial.ParticipantsGP practices will be randomised to either intervention or control clusters with their patients allocated to the same cluster.InterventionThe intervention group will have access to the Healthy.me app tailored for the self-management of gout. The control group patients will have access to the same app modified to remove all functions except the Gout Attack Diary.Primary and secondary outcomesThe proportion of patients whose serum urate concentrations are less than or equal to 0.36 mmol/L after 6 months. Secondary outcomes will be proportions of patients achieving target urate concentrations at 12 months, ULT adherence rates, serum urate concentrations at 6 and 12 months, rates of attacks of gout, quality of life estimations and process and economic evaluations. The study is designed to detect a ≥30% improvement in the intervention group above the expected 50% achievement of target serum urate at 6 months in the control group: power 0.80, significance level 0.05, assumed 'dropout' rate 20%.Ethics and disseminationThis study has been approved by the University of New South Wales Human Research Ethics Committee. Study findings will be disseminated in international conferences and peer-reviewed journal.Trial registration numberACTRN12616000455460.

Project description:BackgroundHeart failure (HF) is a common clinical syndrome associated with substantial morbidity, a heavy economic burden, and high risk of readmission. eHealth self-management interventions may be an effective way to improve HF clinical outcomes.ObjectiveThe aim of this study was to systematically review the evidence for the effectiveness of eHealth self-management in patients with HF.MethodsThis study included only randomized controlled trials (RCTs) that compared the effects of eHealth interventions with usual care in adult patients with HF using searches of the EMBASE, PubMed, CENTRAL (Cochrane Central Register of Controlled Trials), and CINAHL databases from January 1, 2011, to July 12, 2022. The Cochrane Risk of Bias tool (RoB 2) was used to assess the risk of bias for each study. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) criteria were used to rate the certainty of the evidence for each outcome of interest. Meta-analyses were performed using Review Manager (RevMan v.5.4) and R (v.4.1.0 x64) software.ResultsIn total, 24 RCTs with 9634 participants met the inclusion criteria. Compared with the usual-care group, eHealth self-management interventions could significantly reduce all-cause mortality (odds ratio [OR] 0.83, 95% CI 0.71-0.98, P=.03; GRADE: low quality) and cardiovascular mortality (OR 0.74, 95% CI 0.59-0.92, P=.008; GRADE: moderate quality), as well as all-cause readmissions (OR 0.82, 95% CI 0.73-0.93, P=.002; GRADE: low quality) and HF-related readmissions (OR 0.77, 95% CI 0.66-0.90, P<.001; GRADE: moderate quality). The meta-analyses also showed that eHealth interventions could increase patients' knowledge of HF and improve their quality of life, but there were no statistically significant effects. However, eHealth interventions could significantly increase medication adherence (OR 1.82, 95% CI 1.42-2.34, P<.001; GRADE: low quality) and improve self-care behaviors (standardized mean difference -1.34, 95% CI -2.46 to -0.22, P=.02; GRADE: very low quality). A subgroup analysis of primary outcomes regarding the enrolled population setting found that eHealth interventions were more effective in patients with HF after discharge compared with those in the ambulatory clinic setting.ConclusionseHealth self-management interventions could benefit the health of patients with HF in various ways. However, the clinical effects of eHealth interventions in patients with HF are affected by multiple aspects, and more high-quality studies are needed to demonstrate effectiveness.

Project description:BackgroundAtrial fibrillation (AF) is the most common heart rhythm disorder and poses a growing disease burden worldwide because of an aging population. A multidisciplinary approach with an emphasis on patient education and self-management has been demonstrated to improve outcomes for AF through the engagement of patients in their own care. Although electronic tools (e-tools) such as apps have been proposed to provide patient education and facilitate self-management, there have been few studies to guide the development of these tools for patients with AF.ObjectiveThis study aims to explore the perceptions of patients and health care providers (HCPs) and their attitudes toward the use of e-tools for the self-management of AF. It also seeks to elicit the factors that contribute to these attitudes.MethodsSemistructured qualitative interviews with HCPs and patients were conducted to understand the interpretations and expectations of an e-tool that would be used for the self-management of AF. Interview data were analyzed using an exploratory thematic analysis approach to uncover emergent themes and infer ideas of preferred features in a device. A modified technology acceptance model was developed as a framework to help interpret these findings. Data from the HCPs and patients were compared and contrasted.ResultsBoth patients and HCPs thought that an e-tool would be useful in the self-management of AF. Although both groups favored educational content and monitoring of blood pressure, patients expressed more passivity toward self-care and an ambivalence toward the use of technology to monitor their medical condition. This appears to be related to factors such as a patient's age, social support, and their attitudes toward technology. Instead, they favored using the app to contact their HCPs.ConclusionsThis study provides insights into significant differences in the attitudes of patients and HCPs toward the use of e-tools for self-care against their priorities. Understanding patients' motivations and their needs are key to ensuring higher acceptance of such tools.

Project description:BackgroundOlder patients suffering from multimorbidity are at high risk of medication nonadherence. It has been well established that self-management support is an effective strategy to enhance medication adherence for patients with chronic conditions. However, little is known about the effect of the medication self-management intervention in older patients with multimorbidity. This paper presents the protocol for a study that aims to evaluate the effectiveness of a nurse-led medication self-management intervention in improving medication adherence and health outcomes for community-dwelling older patients with multimorbidity.MethodsThe study protocol follows the recommendations of the Standard Protocol Items: Recommendations for Interventional Trials 2013 statement. This study is a multicentre, single-blind, two-arm randomised controlled trial. Older patients with multimorbidity will be recruited from three community health centres in Changsha, China. A total of 136 participants will be randomly allocated to receive usual care or usual care plus the medication self-management intervention. The intervention will be delivered by community nurses. The 6-week intervention includes three face-to-face education sessions and two weekly follow-up phone calls. Participants in the control group continue to receive all respects of usual care offered by community healthcare providers, including chronic disease management, drug prescription, referral to hospital specialists, health education and consultations regarding patients' diseases and treatments during centre visits. The primary outcome is medication adherence as measured by the 5-item Medication Adherence Report Scale. Secondary outcomes include medication self-management capacity (medication knowledge, medication beliefs, medication social support, medication skills, and medication self-efficacy), treatment experiences (medication treatment satisfaction and treatment burden), quality of life, and utilisation of healthcare services. All outcomes will be measured at baseline, immediately post-intervention, and at 3-month post-intervention.DiscussionThis study will provide evidence about the effectiveness of a medication self-management intervention, delivered by nurses, for older patients with multimorbidity and adherence problems. It is expected that the results of the study, if proven effective in improving patients' adherence and health outcomes, will provide evidence-based self-management support strategies for healthcare providers in routine chronic disease management in community settings.Trial registrationThe trial is registered at ChiCTR.org.cn ( ChiCTR2000030011 ; date February 19, 2020).

Project description:BackgroundReassuring patient education and exercise therapy are widely recommended interventions for back pain in clinical guidelines. However, many patients are offered non-guideline endorsed options, and strategies for effective implementation of guideline-based care have not yet been developed. This protocol outlines the evaluation of a strategy for nationwide implementation of standardised patient education and exercise therapy for people with persistent or recurrent back pain in a hybrid implementation-effectiveness design. The strategy and the evaluation were planned using the framework of the Behaviour Change Wheel.MethodsThe main activity of the implementation strategy is a two-days course for physiotherapists and chiropractors in delivering patient education and exercise therapy that is aimed at supporting patient self-management. This comes with ready-to-use patient education materials and exercise programs. The clinical intervention is a group-based program consisting of two sessions of patient education and 8 weeks of supervised exercises. The program uses a cognitive-behavioural approach and the aim of the exercise component is to restore the patient's ability and confidence to move freely. The implementation process is evaluated in a dynamic process monitoring the penetration, adoption and fidelity of the clinical intervention. The clinical intervention and potential effect mechanisms will be evaluated at the patient-level using measures of knowledge, skills, beliefs, performance, self-efficacy and success in self-management. The education of clinicians will be evaluated via clinician-level outcomes, including the Pain Attitudes and Beliefs Scale, the Practitioner Confidence Scale, and the Determinants of Implementation Behaviour Questionnaire. Effects at a national level will be investigated via data from national registries of health care utilisation and sick-leave.DiscussionThis implementation-effectiveness study is designed to evaluate the process of implementing an evidence-based intervention for back pain. It will inform the development of strategies for implementing evidence-based care for musculoskeletal pain conditions, it will enhance the understanding of mechanisms for developing patient self-management skills, and it will demonstrate the outcomes that are achievable in everyday clinical practice.Trial registrationClinicalTrials.gov NCT03570463 . Registered 27 June 2018.

Dataset Information

Effectiveness of an eHealth self-management tool for older adults with multimorbidity (KeepWell): protocol for a hybrid effectiveness-implementation randomised controlled trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Effectiveness of an eHealth self-management tool for older adults with multimorbidity (KeepWell): protocol for a hybrid effectiveness-implementation randomised controlled trial.

Similar Datasets

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