Smart Wearable Insights to Prevent Exacerbations and Recurrence - Rehabilitation Study: SWIPER-REHAB

Not yet recruiting

• Conditions: Cardiovascular Diseases

• Registration Number: NCT06011395
• Lead Sponsor: Imperial College London

Brief Summary

Aims of the study:

* To measure the rate of completion of a digital cardiac rehabilitation programme at Imperial College Healthcare NHS Trust (ICHNT)

* To measure the health economic impact of a digital cardiac rehabilitation programme at ICHNT

Any adult patient eligible for ICHNT cardiac rehabilitation (CR) programmes is eligible to participate. Participants will receive a commercially available smart watch and be asked to wear the device as much as possible. In addition, they will be asked to download a smartphone application called 'Imperial Healthy Hearts', which displays movement and information on heart rate, breathing and oxygen levels to both the participant and the research team (digital data). The Healthy Hearts app also allows the direct care team to provide educational materials to patients as part of their routine care.

The clinical content and structure of the CR programme is determined by the clinical CR team, and does not deviate from established local and national standards and practices.

Researchers will capture physiological data such as heart rate, respiratory rate, blood pressure (where available) and oxygen saturation (where available) via the Healthy Hearts platform. Researchers will also capture clinical information from the electronic health record, and will compare CR programme uptake and completion rates with historical data and national targets.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-21
• Study First Submitted QC: 2023-08-21
• Study First Posted: 2023-08-25
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18
• Study Start: 2025-01-30
• Primary Completion: 2026-03-02
• Study Completion: 2026-03-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1800

Inclusion Criteria

• Age 18 years or above
• Able to give informed consent
• Eligible for Cardiac Rehabilitation programme

Exclusion Criteria

• Any wrist wound, skin pathology or other feature that would prohibit the wearing of a smartwatch
• Any visual impairment preventing the use of the Fitbit or smartphone application.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Uptake of cardiac rehabilitation	12 months	Percentage uptake of cardiac rehabilitation programme (of those that are eligible)

Secondary Outcome Measures

Name	Time	Method
Quality of life assessment (EQ-5D-5L)	12 months	Patient quality of life as measured by the EQ-5D-5L instrument

Trial Locations

Locations (1)

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom