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
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.
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.
Parallel
Digital Lifestyle Platform
BehavioralPatients are going to use the Digital Lifestyle Platform for six months.
Usual Care (Standard Post-Rehabilitation Care)
BehavioralPatients are going to follow their post-rehabilitation care plan without access to the platform
Implementation measure - Feasibility
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
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
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
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.
Global health-related quality of life
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.
Global functioning
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.
Steps per day
Measured with a step counting device of patient's choice after a shared decision making (Fitbit wearable, Omron pedometer).
Users' perceived usability
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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Matthias Wilhelm, MD
Lead sponsor
Insel Gruppe AG, University Hospital Bern
Sponsor institution
