NCT07597031

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
May 2026Feb 2027

First Submitted

Initial submission to the registry

April 28, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

9 months

First QC Date

April 28, 2026

Last Update Submit

May 18, 2026

Conditions

Keywords

TelemedicinePhase III rehabilitationLong-term non-communicable diseases

Outcome Measures

Primary Outcomes (4)

  • 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.

    Collected once a month for the whole six months.

  • 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.

    Collected once a month for the whole six months.

  • 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.

    Collected once a month for the whole six months.

  • 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.

    Continuosly for the whole six months.

Secondary Outcomes (5)

  • 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.

Study Arms (2)

Platform group

EXPERIMENTAL

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.

Behavioral: Digital Lifestyle Platform

Usual Care group

ACTIVE COMPARATOR

Patients follow their usual post-rehabilitation care program without the access to the platform.

Behavioral: Usual Care (Standard Post-Rehabilitation Care)

Interventions

Patients are going to use the Digital Lifestyle Platform for six months.

Platform group

Patients are going to follow their post-rehabilitation care plan without access to the platform

Usual Care group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (≥18 years)
  • 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.).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Inselspital

Bern, Canton of Bern, 3010, Switzerland

RECRUITING

Center for Rehabilitation & Sports Medicine, Berner Reha Zentrum

Schwendi, Heiligenschwendi, 3625, Switzerland

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Matthias Wilhelm, Prof. Dr. med.

    Center for Rehabilitation & Sports Medicine, Berner Reha Zentrum and Inselspital, Bern University Hospital, University of Bern

    PRINCIPAL INVESTIGATOR
  • Thimo Marcin, PhD

    Center for Rehabilitation & Sports Medicine, Berner Reha Zentrum and Inselspital, Bern University Hospital, University of Bern

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthias Wilhelm, Prof. Dr. med.

CONTACT

Branislav Savic, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: This study uses a parallel assignment model. Participants are assigned to one of two groups: an intervention group with access to a digital lifestyle platform and a control group receiving usual post-rehabilitation care. Each participant remains in their assigned group throughout the study, allowing comparison of outcomes between the two conditions over time.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

April 28, 2026

First Posted

May 19, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

May 19, 2026

Record last verified: 2026-05

Locations