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Chronic Obstructive Pulmonary Disease (COPD)Feas PlatfNCT07597031

Feasibility Study of a Digital Interactive Life-style Platform for Individuals After Rehabilitation

A study testing Digital Lifestyle Platform in people with Chronic Obstructive Pulmonary Disease (COPD) and Acute Coronary Syndrome, run by Matthias Wilhelm, MD at 2 sites in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Digital Lifestyle Platform
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
2 sitesSwitzerland
Study dates
1 May 2026to 1 Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.).

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Matthias Wilhelm, Prof. Dr. med. contact

+41 632 89 86

matthias.wilhelm@insel.ch

Branislav Savic, PhD contact

+41784043583

branislav.savic@insel.ch

Switzerland2 sites, 2 recruiting
  • University Hospital Inselspital

    Bern, Canton of Bern, 3010

    Matthias Wilhelm, Prof. Dr. med., +41 632 89 86, matthias.wilhelm@insel.ch

    Branislav Savic, PhD, +41784043583, branislav.savic@insel.ch

    Recruiting
  • Center for Rehabilitation & Sports Medicine, Berner Reha Zentrum

    Schwendi, Heiligenschwendi, 3625

    Matthias Wilhelm, Prof. Dr. med., +41 632 89 86, matthias.wilhelm@insel.ch

    Thimo Marcin, PhD, thimo.marcin@insel.ch

    Recruiting

Other trials in Switzerland

About this study

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:

Read more

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

Read the detailed description

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.

Being tested
Digital Lifestyle Platform, Usual Care (Standard Post-Rehabilitation Care)
Keywords
Telemedicine, Phase III rehabilitation, Long-term non-communicable diseases
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Digital Lifestyle PlatformBehavioural

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

  • Usual Care (Standard Post-Rehabilitation Care)Behavioural

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

Study groups in NCT07597031
Study groupRoleWhat they receive
Platform groupExperimentalIn 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.
Receives: Behavioral: Digital Lifestyle Platform
Usual Care groupActive comparatorPatients follow their usual post-rehabilitation care program without the access to the platform.
Receives: Behavioral: Usual Care (Standard Post-Rehabilitation Care)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Collected once a month for the whole six months.

  2. 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.

    Measured: Collected once a month for the whole six months.

  3. 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.

    Measured: Collected once a month for the whole six months.

  4. 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.

    Measured: Continuosly for the whole six months.

Secondary outcomes (5)
  1. 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.

    Measured: Collected at three time points namely (T0) at discharge, (T1) three months after discharge, and (T2) six months after discharge.

  2. 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.

    Measured: Collected at three time points namely (T0) at discharge, (T1) three months after discharge, and (T2) six months after discharge.

  3. Steps per day

    Measured with a step counting device of patient's choice after a shared decision making (Fitbit wearable, Omron pedometer).

    Measured: Collected continuously for six months

  4. 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.

    Measured: PPSQ will be collected at (T1) three months after discharge and (T2) six months after discharge, respectively.

  5. Users' acceptance of telehealth or digital health technologies

    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.

    Measured: SUTAQ will be collected at (T1) three months after discharge and (T2) six months after discharge, respectively.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2026
  2. Study start1 May 2026 (estimated)
  3. Primary completion1 Feb 2027 (estimated)
  4. Study completion1 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07597031
Sponsor's protocol ID
2026-00073
Acronym
Feas Platf
Status last verified
May 2026
First submitted
28 Apr 2026
Last updated
19 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Digital Lifestyle Platform in people with Chronic Obstructive Pulmonary Disease (COPD) and Acute Coronary Syndrome, run by Matthias Wilhelm, MD at 2 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Matthias Wilhelm, Prof. Dr. med. (+41 632 89 86, matthias.wilhelm@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Implementation measure - Feasibility (time frame: Collected once a month for the whole six months.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.

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