Evaluation of a digital health application in conjunction with a smartwatch in patients undergoing cardiac rehabilitation.
Résumé de l'étude
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)
Intervention étudiée
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)
Maladie en cours d'investigation
Patients who have suffered a cardiac event and have started a cardiac rehabilitation program.
(BASEC)
- Signed and returned informed consent; - Aged between 40 and 80 years; - Have suffered a heart attack and are being treated with interventions or medications allowed for this study; - Diagnosis of stable chronic coronary artery disease; - Participation in an outpatient cardiac rehabilitation program or planned participation in such a program within 5 days of admission to the study; - Sufficient communication and understanding in German, English, Italian, or French; - Use of an iPhone with German, English, Italian, or French language settings. The phone must be an iPhone 8 or newer with at least iOS 16; - Willingness to test innovative technologies. (BASEC)
Critères d'exclusion
- Severe chronic coronary artery disease or any other diagnosis that prevents any form of exercise during the study; - Heart failure or a previous heart transplant; - Heart valve replacement or arrhythmias; - Any other disease deemed significant by the study physician; - Pregnancy; - Unable to follow the study procedures; - Severe symptoms of depression; - Known or suspected non-compliance, drug or alcohol abuse; - Inability to attend the rehabilitation clinic and study-related appointments, or participation in a different schedule/program than the 12-week rehabilitation program, or participation in an inpatient rehabilitation program; - Already participating in another clinical trial using a different digital health application or where the effects of the intervention are known to influence this study; - Already wearing a smartwatch to track their fitness and activity outside of their rehabilitation program and unwilling to use only the smartwatch connected to CARITY-P for the duration of the clinical trial; - Family members of the sponsor, study center, their relatives, employees, and other dependent persons. (BASEC)
Lieu de l’étude
Lausanne, Luzern, St-Gall, Zurich
(BASEC)
Sponsor
Carity AG
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Aliaksei Tsitovich
+41 76 424 85 20
aliaksei.tsitovich@cluttercarity.careCarity AG
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
10.10.2023
(BASEC)
Identifiant de l'essai ICTRP
non disponible
Titre officiel (approuvé par le comité d'éthique)
CARITY-P: A targeted approach to ensuring CARe and ActivITY persistence in mid- to older-age persons during and after cardiac rehabilitation following a cardiovascular event or intervention (BASEC)
Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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