Telerehabilitation After Stroke Using Readily Available Technology: A Randomized Controlled Trial.
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ABSTRACT: Background
The number of people living with stroke has increased demand for rehabilitation. A potential solution is telerehabilitation for health care delivery to promote self-management. One such approach is the Augmented Community Telerehabilitation Intervention (ACTIV). This structured 6-month program uses limited face-to-face sessions, telephone contact, and text messages to augment stroke rehabilitation.Objective
To investigate whether ACTIV improved physical function compared with usual care.Methods
This 2-arm, parallel randomized controlled trial was conducted in 4 New Zealand centers. Inclusion criteria were patients with first-ever stroke, age >20 years, and discharged home. A blinded assessor completed outcome measurement in participants' homes at baseline, postintervention, and 6 months postintervention. Stratified block randomization occurred after baseline assessment, with participants allocated to ACTIV or usual care control.Results
A total of 95 people were recruited (ACTIV: n = 47; control: n = 48). Postintervention intention-to-treat analysis found a nonsignificant difference between the groups in scores (4·51; P = .07) for physical function (measured by the physical subcomponent of the Stroke Impact Scale). The planned per-protocol analysis (ACTIV: n = 43; control: n = 48) found a significant difference in physical function between the groups (5·28; P = .04). Improvements in physical function were not maintained at the 12-month follow-up.Conclusions
ACTIV was not effective in improving physical function in the ACTIV group compared with the usual care group. The per-protocol analysis raises the possibility that for those who receive more than 50% of the intervention, ACTIV may be effective in preventing deterioration or even improving physical function in people with stroke, in the period immediately following discharge from hospital.
SUBMITTER: Saywell NL
PROVIDER: S-EPMC7739128 | biostudies-literature | 2021 Jan
REPOSITORIES: biostudies-literature
Publications
Telerehabilitation After Stroke Using Readily Available Technology: A Randomized Controlled Trial.
Saywell Nicola L NL Vandal Alain C AC Mudge Suzie S Hale Leigh L Brown Paul P Feigin Valery V Hanger Carl C Taylor Denise D
Neurorehabilitation and neural repair 20201116 1
<h4>Background</h4>The number of people living with stroke has increased demand for rehabilitation. A potential solution is telerehabilitation for health care delivery to promote self-management. One such approach is the Augmented Community Telerehabilitation Intervention (ACTIV). This structured 6-month program uses limited face-to-face sessions, telephone contact, and text messages to augment stroke rehabilitation.<h4>Objective</h4>To investigate whether ACTIV improved physical function compar ...[more]
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Project description:BACKGROUND:Accurate safety monitoring in HIV vaccine trials is vital to eventual licensure and consequent uptake of products. Current practice in preventive vaccine trials, under the HIV Vaccine Trials Network (HVTN), is to capture related side effects in a hardcopy tool. The reconciliation of this tool, 2 weeks after vaccination at the safety visit, is time consuming, laborious, and fraught with error. Unstructured Supplementary Service Data (USSD), commonly used to purchase airtime, has been suggested for collection of safety data in vaccine trials. With saturated access to mobile phones in South Africa, this cheap, accessible tool may improve accuracy and completeness of collected data and prove feasible and acceptable over the hardcopy tool. OBJECTIVE:The objective of our study is to develop and implement a USSD tool for real-time safety data collection that is feasible and acceptable to participants and staff, allowing for a comparison with the hardcopy tool in terms of completeness and accuracy. METHODS:This feasibility study is being conducted at a single study site, the Centre for the AIDS Programme of Research in South Africa eThekwini Clinical Research site, in South Africa. The feasibility study is nested within a parent phase 1/2a preventive HIV vaccine trial (HVTN 108) as an open-label, randomized controlled trial, open to all consenting parent trial participants. Participants are randomly assigned in a 1:1 ratio to the hardcopy or USSD tool, with data collection targeted to the third and fourth injection time points in the parent trial. Online feasibility and acceptability surveys will be completed by staff and participants at the safety visit. We will itemize and compare error rates between the hardcopy tool and the USSD printout and associated source documentation. We hypothesize that the USSD tool will be shown to be feasible and acceptable to staff and participants and to have superior quality and completion rates to the hardcopy tool. RESULTS:The study has received regulatory approval. We have designed and developed the USSD tool to include all the data fields required for reactogenicity reporting. Online feasibility and accessibility surveys in both English and isiZulu have been successfully installed on a tablet. Data collection is complete, but analysis is pending. CONCLUSIONS:Several HIV preventive vaccine trials are active in Southern Africa, making tools to improve efficiencies and minimize error necessary. Our results will help to determine whether the USSD tool can be used in future vaccine studies and can eventually be rolled out. TRIAL REGISTRATION:ClincalTrials.gov NCT02915016; https://clinicaltrials.gov/ct2/show/NCT02915016 (Archived by WebCite at http://www.webcitation.org/71h0cztDM). REGISTERED REPORT IDENTIFIER:RR1-10.2196/9396.
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Project description:BACKGROUND:Cardiovascular disease is the leading cause of mortality worldwide, accounting for 13%-15% of all deaths. Cardiac rehabilitation has poor compliance and adherence. Telerehabilitation has been introduced to increase patients' participation, access, and adherence with the help of digital technologies. The target group is patients with heart failure. A telerehabilitation program called "Future Patient" has been developed and consists of three phases: (1) titration of medicine (0-3 months), (2) implementation of the telerehabilitation protocols (3 months), and (3) follow-up with rehabilitation in everyday life (6 months). Patients in the Future Patient program measure their blood pressure, pulse, weight, number of steps taken, sleep, and respiration and answer questions online regarding their well-being. All data are transmitted and accessed in the HeartPortal by patients and health care professionals. OBJECTIVE:The aim of this paper is to describe the research design, outcome measures, and data collection techniques in the clinical test of the Future Patient Telerehabilitation Program for patients with heart failure. METHODS:A randomized controlled study will be performed. The intervention group will follow the Future Patient Telerehabilitation program, and the control group will follow the traditional cardiac rehabilitation program. The primary outcome is quality of life measured by the Kansas City Cardiomyopathy Questionnaire. Secondary outcomes are development of clinical data; illness perception; motivation; anxiety and depression; health and electronic health literacy; qualitative exploration of patients', spouses', and health care professionals' experiences of participating in the telerehabilitation program; and a health economy evaluation of the program. Outcomes were assessed using questionnaires and through the data generated by digital technologies. RESULTS:Data collection began in December 2016 and will be completed in October 2019. The study results will be published in peer-reviewed journals and presented at international conferences. Results from the Future Patient Telerehabilitation program are expected to be published by the spring of 2020. CONCLUSIONS:The expected outcomes are increased quality of life, increased motivation and illness perception, reduced anxiety and depressions, improved electronic health literacy, and health economics benefits. We expect the study to have a clinical impact for future telerehabilitation of patients with heart failure. TRIAL REGISTRATION:ClinicalTrials.gov NCT03388918; https://clinicaltrials.gov/ct2/show/NCT03388918. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/14517.
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