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

18 мая 2026 г. обновлено: 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

Обзор исследования

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Оцененный)

240

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Branislav Savic, PhD
  • Номер телефона: +41784043583
  • Электронная почта: branislav.savic@insel.ch

Учебное резервное копирование контактов

  • Имя: Matthias Wilhelm, Prof. Dr. med.
  • Номер телефона: +41 632 89 86
  • Электронная почта: matthias.wilhelm@insel.ch

Места учебы

    • Canton of Bern
      • Bern, Canton of Bern, Швейцария, 3010
        • Рекрутинг
        • University Hospital Inselspital
        • Контакт:
          • Branislav Savic, PhD
          • Номер телефона: +41784043583
          • Электронная почта: branislav.savic@insel.ch
        • Контакт:
          • Matthias Wilhelm, Prof. Dr. med.
          • Номер телефона: +41 632 89 86
          • Электронная почта: matthias.wilhelm@insel.ch
    • Heiligenschwendi
      • Schwendi, Heiligenschwendi, Швейцария, 3625
        • Рекрутинг
        • Center for Rehabilitation & Sports Medicine, Berner Reha Zentrum
        • Контакт:
          • Matthias Wilhelm, Prof. Dr. med.
          • Номер телефона: +41 632 89 86
          • Электронная почта: matthias.wilhelm@insel.ch
        • Контакт:

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Исследования в области здравоохранения
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Тройной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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.
Patients are going to use the Digital Lifestyle Platform for six months.
Активный компаратор: Usual Care group
Patients follow their usual post-rehabilitation care program without the access to the platform.
Patients are going to follow their post-rehabilitation care plan without access to the platform

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Implementation measure - Feasibility
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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.

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Global health-related quality of life
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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.

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Следователи

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

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

1 мая 2026 г.

Первичное завершение (Оцененный)

1 февраля 2027 г.

Завершение исследования (Оцененный)

1 февраля 2027 г.

Даты регистрации исследования

Первый отправленный

28 апреля 2026 г.

Впервые представлено, что соответствует критериям контроля качества

18 мая 2026 г.

Первый опубликованный (Действительный)

19 мая 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

19 мая 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

18 мая 2026 г.

Последняя проверка

1 мая 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Планирование данных отдельных участников (IPD)

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НЕ РЕШЕНО

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Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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