Smart Watch Insights to Prevent Exacerbations and Recurrence - Health Study: SWIPER-HEALTH

Sponsor

Imperial College London (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT06011395

Collaborator

(none)

1,800

Enrollment

Location

Anticipated Duration (Months)

74.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases	Device: Smartwatch Device: Imperial Healthy Hearts app

Study Design

Study Type:

Observational

Anticipated Enrollment :

1800 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Smart Watch Insights to Prevent Exacerbations and Recurrence - Health Study: SWIPER-HEALTH

Anticipated Study Start Date :

Aug 30, 2023

Anticipated Primary Completion Date :

Aug 30, 2025

Anticipated Study Completion Date :

Aug 30, 2025

Outcome Measures

Primary Outcome Measures

Uptake of cardiac rehabilitation [12 months]
Percentage uptake of cardiac rehabilitation programme (of those that are eligible)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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.