Идёт набор NCT07597031

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

Без фазы С лечением Chronic Obstructive Pulmonary Disease (COPD) Acute Coronary Syndrome Fragility Fracture Minor Stroke

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Digital Lifestyle Platform, Usual Care (Standard Post-Rehabilitation Care).
Кому может быть актуально: Состояния в реестре: Chronic Obstructive Pulmonary Disease (COPD), Acute Coronary Syndrome, Fragility Fracture, Minor Stroke. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Швейцария
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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

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.

Вмешательства

Поведенческое Digital Lifestyle Platform
Patients are going to use the Digital Lifestyle Platform for six months.
Поведенческое Usual Care (Standard Post-Rehabilitation Care)
Patients are going to follow their post-rehabilitation care plan without access to the platform

Первичные конечные точки

Implementation measure - Feasibility [Срок оценки: Collected once a month for the whole six months.]
Implementation measure - Acceptability [Срок оценки: Collected once a month for the whole six months.]
Implementation measure - Appropriateness [Срок оценки: Collected once a month for the whole six months.]
Implementation measure - Fidelity [Срок оценки: Continuosly for the whole six months.]

Вторичные конечные точки (5)

Global health-related quality of life [Срок оценки: Collected at three time points namely (T0) at discharge, (T1) three months after discharge, and (T2) six months after discharge.]
Global functioning [Срок оценки: Collected at three time points namely (T0) at discharge, (T1) three months after discharge, and (T2) six months after discharge.]
Steps per day [Срок оценки: Collected continuously for six months]
Users' perceived usability [Срок оценки: 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 [Срок оценки: SUTAQ will be collected at (T1) three months after discharge and (T2) six months after discharge, respectively.]

Критерии участия

Критерии включения

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.).