Evaluation of a digital health application in conjunction with a smartwatch in patients undergoing cardiac rehabilitation.

Zusammenfassung der Studie

After a cardiac event, a cardiac rehabilitation program is often prescribed to support the healing of the heart. Physical activity is a central element of rehabilitation and must be performed regularly over a sufficiently long period to allow for complete recovery. During the rehabilitation program, the patient often cannot engage in sufficient physical activity outside the center and is not always able to recognize the progress made. At the end of the rehabilitation program, the patient returns home and no longer benefits from structured support from the rehabilitation team. In the long term, the patient's motivation to maintain an adequate level of physical activity may diminish. This study aims to investigate whether the digital health application CARITY, in combination with an Apple Watch, helps the patient achieve and maintain a higher level of physical activity than with rehabilitation alone.

(BASEC)

Untersuchte Intervention

Participation in this study occurs simultaneously with the patients' regular cardiac rehabilitation program. Patients are only asked to attend an additional visit at the end of the study and a few additional examinations. Patients are randomly assigned to one of two groups. The "experimental group" participates in their planned rehabilitation and additionally receives the Carity app on their iPhone as well as a connected Apple Watch. The "control group" participates in the planned rehabilitation but without the app and the connected Apple Watch. Patients will visit the clinic three times over a period of 6 months. Visit 1 takes place simultaneously with the admission to the rehabilitation program. All patients sign an informed consent form, complete a quality of life questionnaire, perform a 6-minute walk test, and have their breathing measured during physical activity (if possible). Patients in the experimental group receive the Carity app and a connected Apple Watch. Visit 2 occurs about 3 months later, at the same time as discharge from the rehabilitation program. All patients complete a quality of life questionnaire, perform a 6-minute walk test, and have their breathing measured during physical activity. Patients in the experimental group complete a questionnaire on the usability of the Carity app and the connected Apple Watch. Visit 3 occurs about 6 months after the start of the study. During visit 3, the same examinations and tests as in visit 2 are conducted. Patients in the experimental group uninstall the Carity app from their iPhone and return the Apple Watch. Between visits 1-2 and 2-3, all patients participate in their rehabilitation program. Patients in the experimental group wear the watch for at least 2 hours per day and during each training session. Additionally, they regularly answer questions and perform tasks required by the app, sending weekly reports to the rehabilitation team.

(BASEC)

Untersuchte Krankheit(en)

Patients who have suffered a cardiac event and have started a cardiac rehabilitation program.

(BASEC)

Sponsor

Carity AG

(BASEC)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Zürich

(BASEC)

Datum der Bewilligung durch die Ethikkommission

10.10.2023

(BASEC)

Ergebnisse der Studie