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Feasibility Study of a Digital Interactive Life-style Platform for Individuals After Rehabilitation (Feas Platf)

18 maja 2026 zaktualizowane przez: Matthias Wilhelm, MD

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

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

240

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Szwajcaria
    • Canton of Bern
      • Bern, Canton of Bern, Szwajcaria, 3010
    • Heiligenschwendi
      • Schwendi, Heiligenschwendi, Szwajcaria, 3625
        • Rekrutacyjny
        • Center for Rehabilitation & Sports Medicine, Berner Reha Zentrum
        • Kontakt:
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Badania usług zdrowotnych
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: Digital Lifestyle Platform
Patients are going to use the Digital Lifestyle Platform for six months.
Aktywny komparator: Usual Care group
Patients follow their usual post-rehabilitation care program without the access to the platform.
Behawioralne: Usual Care (Standard Post-Rehabilitation Care)
Patients are going to follow their post-rehabilitation care plan without access to the platform

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Implementation measure - Feasibility
Ramy czasowe: 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.
Collected once a month for the whole six months.
Implementation measure - Acceptability
Ramy czasowe: 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.
Collected once a month for the whole six months.
Implementation measure - Appropriateness
Ramy czasowe: 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.
Collected once a month for the whole six months.
Implementation measure - Fidelity
Ramy czasowe: 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.
Continuosly for the whole six months.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Global health-related quality of life
Ramy czasowe: Collected at three time points namely (T0) at discharge, (T1) three months after discharge, and (T2) six months after discharge.
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.
Collected at three time points namely (T0) at discharge, (T1) three months after discharge, and (T2) six months after discharge.
Global functioning
Ramy czasowe: Collected at three time points namely (T0) at discharge, (T1) three months after discharge, and (T2) six months after discharge.
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.
Collected at three time points namely (T0) at discharge, (T1) three months after discharge, and (T2) six months after discharge.
Steps per day
Ramy czasowe: Collected continuously for six months
Measured with a step counting device of patient's choice after a shared decision making (Fitbit wearable, Omron pedometer).
Collected continuously for six months
Users' perceived usability
Ramy czasowe: PPSQ will be collected at (T1) three months after discharge and (T2) six months after discharge, respectively.
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.
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
Ramy czasowe: SUTAQ will be collected at (T1) three months after discharge and (T2) six months after discharge, respectively.
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.
SUTAQ will be collected at (T1) three months after discharge and (T2) six months after discharge, respectively.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Matthias Wilhelm, MD

Śledczy

  • Główny śledczy: Matthias Wilhelm, Prof. Dr. med., Center for Rehabilitation & Sports Medicine, Berner Reha Zentrum and Inselspital, Bern University Hospital, University of Bern
  • Główny śledczy: Thimo Marcin, PhD, Center for Rehabilitation & Sports Medicine, Berner Reha Zentrum and Inselspital, Bern University Hospital, University of Bern

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 maja 2026

Zakończenie podstawowe (Szacowany)

1 lutego 2027

Ukończenie studiów (Szacowany)

1 lutego 2027

Daty rejestracji na studia

Pierwszy przesłany

28 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

18 maja 2026

Pierwszy wysłany (Rzeczywisty)

19 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

19 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

18 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2026-00073

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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