Feasibility Study of a Digital Interactive Life-style Platform for Individuals After Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Implementation measure - Feasibility
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.).
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Digital Lifestyle Platform (Behavioral)
Usual Care group
Patients follow their usual post-rehabilitation care program without the access to the platform.
干预措施: Usual Care (Standard Post-Rehabilitation Care) (Behavioral)
结局指标
主要结局
Implementation measure - Feasibility
时间窗: Collected once a month for the whole six months.
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.
Implementation measure - Acceptability
时间窗: Collected once a month for the whole six months.
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.
Implementation measure - Appropriateness
时间窗: Collected once a month for the whole six months.
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.
Implementation measure - Fidelity
时间窗: Continuosly for the whole six months.
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.
次要结局
- Global health-related quality of life(Collected at three time points namely (T0) at discharge, (T1) three months after discharge, and (T2) six months after discharge.)
- Global functioning(Collected at three time points namely (T0) at discharge, (T1) three months after discharge, and (T2) six months after discharge.)
- Steps per day(Collected continuously for six months)
- Users' perceived usability(PPSQ will be collected at (T1) three months after discharge and (T2) six months after discharge, respectively.)
- Users' acceptance of telehealth or digital health technologies(SUTAQ will be collected at (T1) three months after discharge and (T2) six months after discharge, respectively.)
研究者
Matthias Wilhelm, MD
Prof. Dr. med.
Insel Gruppe AG, University Hospital Bern