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

18 maggio 2026 aggiornato da: 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

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

240

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Svizzera
    • Canton of Bern
      • Bern, Canton of Bern, Svizzera, 3010
        • Reclutamento
        • University Hospital Inselspital
        • Contatto:
        • Contatto:
    • Heiligenschwendi
      • Schwendi, Heiligenschwendi, Svizzera, 3625
        • Reclutamento
        • Center for Rehabilitation & Sports Medicine, Berner Reha Zentrum
        • Contatto:
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: Digital Lifestyle Platform
Patients are going to use the Digital Lifestyle Platform for six months.
Comparatore attivo: Usual Care group
Patients follow their usual post-rehabilitation care program without the access to the platform.
Comportamentale: Usual Care (Standard Post-Rehabilitation Care)
Patients are going to follow their post-rehabilitation care plan without access to the platform

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Implementation measure - Feasibility
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Global health-related quality of life
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Matthias Wilhelm, MD

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 maggio 2026

Completamento primario (Stimato)

1 febbraio 2027

Completamento dello studio (Stimato)

1 febbraio 2027

Date di iscrizione allo studio

Primo inviato

28 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

18 maggio 2026

Primo Inserito (Effettivo)

19 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

19 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2026-00073

Piano per i dati dei singoli partecipanti (IPD)

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INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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