Feasibility Study of a Digital Interactive Life-style Platform for Individuals After Rehabilitation (Feas Platf)
The goal of this clinical trial is to evaluate the feasibility and usability of a digital lifestyle platform designed to support patients after discharge from inpatient rehabilitation. It will also assess patient engagement and the potential of the platform to support long-term self-management and healthy lifestyle behaviors in an outpatient setting.
The main questions it aims to answer are:
Is the platform feasible and acceptable for patients after rehabilitation? Do patients engage with and regularly use the platform over time? Can personalized digital recommendations support adherence to healthy behaviors and self-management?
Researchers will evaluate a telemedicine platform that delivers individualized suggestions, including lifestyle applications, educational content, and advice from healthcare professionals. The content is tailored to patient needs and continuously adapted based on patient feedback.
Participants will:
Use the digital platform after discharge from inpatient rehabilitation for a defined follow-up period Receive personalized recommendations through the platform Rate the usefulness of recommendations to enable continuous adaptation Attend study visits or remote assessments to evaluate usability, engagement, and outcomes Continue standard outpatient care alongside the intervention
연구 개요
상태
상세 설명
The number of patients in need of inpatient rehabilitation programs is constantly rising due to demographic changes, increasing prevalence of cardiovascular, respiratory, neurological, and musculoskeletal disorders, and multimorbidity. The patient journey typically starts with acute care (Phase I), followed by either in- or outpatient rehabilitation (Phase II), and then ambulatory long-term care in the community (Phase III). Phase II inpatient rehabilitation is usually of short duration, and outpatient rehabilitation is often difficult to access and time-consuming for healthcare professionals (HCPs). No structured health support exists in Phase III, and patients often fall off the "rehabilitation cliff," meaning that rehabilitation stops abruptly after discharge. As a result, patients often struggle in the long term to adhere to therapies, to self-manage their clinical condition, and to maintain healthy habits, ultimately leading to relapses. Patient support through the internet, mobile communication, and other online platforms-also known as telemedicine-has the potential to prevent disease progression and re-hospitalization by promoting healthy lifestyle behaviors. In addition, telemedicine interventions may reduce costs for the healthcare system compared to traditional care. Nevertheless, despite these potential benefits, their implementation in clinical practice remains challenging.
The stupy is embedded in the project "Co-creation and evaluation of a sensor-based closed-loop telecare programme for multimorbid patients after inpatient rehabilitation." funded by the SF-Board of the University of Bern, Switzerland. One of the main aims of COPAIN is to co-create and evaluate a telemedicine-based solution to enhance patients' health literacy, self-management skills, and monitoring of their health status in Phase III. To achieve this, a digital lifestyle platform was developed. The platform has two interfaces: one for healthcare professionals and one for patients. Healthcare professionals provide patients with personalized suggestions tailored to their individual health needs. These suggestions may include existing lifestyle applications, educational content such as videos or articles, and direct advice from healthcare professionals. The list of suggestions is regularly reviewed and updated to ensure suitability. After using a suggestion, patients are asked to rate it, allowing healthcare professionals to adapt future recommendations accordingly. At present, it is unknown how well this platform will be received by patients discharged from cardiopulmonary, neurological, or musculoskeletal rehabilitation.
The primary objective of the present project is to evaluate the feasibility of implementing the platform in the patient journey following discharge from Phase II inpatient rehabilitation. The secondary objective is to explore its overall effectiveness. To achieve these aims, 240 participants will be recruited prior to discharge and assigned either to the platform group or to a control group receiving standard care. The study will include participants across four clinical cohorts: acute coronary syndrome or ischemic heart failure, chronic obstructive pulmonary disease, fragility fractures, and minor stroke, with 60 participants in each group. This project has the potential to support future research aimed at improving care for patient populations that currently receive limited support after rehabilitation.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Branislav Savic, PhD
- 전화번호: +41784043583
- 이메일: branislav.savic@insel.ch
연구 연락처 백업
- 이름: Matthias Wilhelm, Prof. Dr. med.
- 전화번호: +41 632 89 86
- 이메일: matthias.wilhelm@insel.ch
연구 장소
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Canton of Bern
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Bern, Canton of Bern, 스위스, 3010
- 모병
- University Hospital Inselspital
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연락하다:
- Branislav Savic, PhD
- 전화번호: +41784043583
- 이메일: branislav.savic@insel.ch
-
연락하다:
- Matthias Wilhelm, Prof. Dr. med.
- 전화번호: +41 632 89 86
- 이메일: matthias.wilhelm@insel.ch
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Heiligenschwendi
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Schwendi, Heiligenschwendi, 스위스, 3625
- 모병
- Center for Rehabilitation & Sports Medicine, Berner Reha Zentrum
-
연락하다:
- Matthias Wilhelm, Prof. Dr. med.
- 전화번호: +41 632 89 86
- 이메일: matthias.wilhelm@insel.ch
-
연락하다:
- Thimo Marcin, PhD
- 이메일: thimo.marcin@insel.ch
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adults (≥18 years)
- 10 or less days before discharge from inpatient rehabilitation at the Bern Rehab Center in Heiligenschwendi or the Insel Hospital (both belonging to the Insel Group)
- Belonging to one of the following clinical cohorts: acute coronary syndrome or ischemic heart failure; chronic obstructive pulmonary disease (COPD) - clinically diagnosed and confirmed by pulmonary specialist; fragility fracture - e.g., hip fracture or other low-energy fractures; minor stroke, clinically confirmed ischemic or hemorrhagic stroke with mild neurological deficits.
- Able to provide informed consent.
- Access to and ability to use a device that has internet access (e.g., tablet, smartphone, laptop, etc.).
Exclusion Criteria:
- Cognitive or psychiatric condition interfering with consent or use of the app.
- Physical disability preventing digital device use without support.
- Heavy language production or comprehension impairments.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Platform group
In the Platform group, participants will use a digital lifestyle platform for six months after discharge, accessible via personal devices (e.g., smartphone, tablet, laptop).
Based on a baseline assessment at discharge, trained study personnel identify relevant impaired domains and select tailored recommendations from a predefined list, which are delivered via the platform.
Content includes lifestyle applications, educational materials (e.g., videos, articles), and healthcare professional advice, provided in accessible visual formats.
Participants can organize suggestions into daily or weekly plans.
After each use, participants rate the recommendations, allowing iterative adaptation by the study team.
All content is reviewed for quality and suitability.
A chat function enables communication with study personnel.
The platform is continuously refined based on user feedback.
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Patients are going to use the Digital Lifestyle Platform for six months.
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활성 비교기: Usual Care group
Patients follow their usual post-rehabilitation care program without the access to the platform.
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Patients are going to follow their post-rehabilitation care plan without access to the platform
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Implementation measure - Feasibility
기간: Collected once a month for the whole six months.
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Feasibility refers to the extent to which the intervention can be successfully implemented in a given setting and will be measured using the Feasibility of Intervention Measure (FIM).
Higher scores indicate greater perceived feasibility of the intervention.
Minimum score = 4; Maximum score = 20.
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Collected once a month for the whole six months.
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Implementation measure - Acceptability
기간: Collected once a month for the whole six months.
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Acceptability reflects how satisfactory or agreeable the intervention is perceived by patients and will be assessed with the Acceptability of Intervention Measure (AIM).
Higher scores indicate greater perceived acceptability of the intervention.
Minimum score = 4; Maximum score = 20.
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Collected once a month for the whole six months.
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Implementation measure - Appropriateness
기간: Collected once a month for the whole six months.
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Appropriateness refers to the perceived fit, relevance, and compatibility of the intervention for patients' post-discharge context and will be measured using the Intervention Appropriateness Measure (IAM).
Higher scores indicate greater perceived appropriateness of the intervention.
Minimum score = 4; Maximum score = 20.
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Collected once a month for the whole six months.
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Implementation measure - Fidelity
기간: Continuosly for the whole six months.
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Fidelity refers to the extent to which the intervention is used as intended and will be assessed based on platform usage over time.
Minimum and maximum scores = N/A.
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Continuosly for the whole six months.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Global health-related quality of life
기간: Collected at three time points namely (T0) at discharge, (T1) three months after discharge, and (T2) six months after discharge.
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Measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health 10 (PROMIS-10).
Higher scores indicate better global health / better health-related quality of life.
The raw scores are converted to T-score.
Thus, minimum and maximum scores vary.
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Collected at three time points namely (T0) at discharge, (T1) three months after discharge, and (T2) six months after discharge.
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Global functioning
기간: Collected at three time points namely (T0) at discharge, (T1) three months after discharge, and (T2) six months after discharge.
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Measured with a speech-based instrument.
Specifically, the transcribed, de-identified speech recordings are analyzed by an existing Large Language Model (LLM) that recognizes which domain/s according to the International Classification of Functioning, Disability and Health (ICF) is/are impaired.
The LLM is developed within the COPAIN project as well but outside of the present feasibility study.
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Collected at three time points namely (T0) at discharge, (T1) three months after discharge, and (T2) six months after discharge.
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Steps per day
기간: Collected continuously for six months
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Measured with a step counting device of patient's choice after a shared decision making (Fitbit wearable, Omron pedometer).
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Collected continuously for six months
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Users' perceived usability
기간: PPSQ will be collected at (T1) three months after discharge and (T2) six months after discharge, respectively.
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Only the patients randomized in the Platform group, will be asked to complete the Post Study System Usability Questionnaire (PSSUQ), The PSSUQ is a standardized questionnaire developed to assess users' perceived usability of a technological system, including system usefulness, information quality, and interface quality.
Lower scores indicate better perceived usability and user satisfaction (i.e., less difficulty using the system).
Minimum score = 16; Maximum score = 112.
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PPSQ will be collected at (T1) three months after discharge and (T2) six months after discharge, respectively.
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Users' acceptance of telehealth or digital health technologies
기간: SUTAQ will be collected at (T1) three months after discharge and (T2) six months after discharge, respectively.
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Only the patients randomized in the Platform group, will be asked to complete the Service User Technology Acceptability Questionnaire (SUTAQ).
The SUTAQ evaluates users' acceptance of telehealth or digital health technologies, including perceived benefit, privacy concerns, accessibility, and satisfaction.
Higher scores generally indicate greater acceptability of the technology.
Minimum score = 22; Maximum score = 132.
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SUTAQ will be collected at (T1) three months after discharge and (T2) six months after discharge, respectively.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Matthias Wilhelm, Prof. Dr. med., Center for Rehabilitation & Sports Medicine, Berner Reha Zentrum and Inselspital, Bern University Hospital, University of Bern
- 수석 연구원: Thimo Marcin, PhD, Center for Rehabilitation & Sports Medicine, Berner Reha Zentrum and Inselspital, Bern University Hospital, University of Bern
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2026-00073
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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