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

Cardiovascular Diseases Clinical Trial

— SWIPER-HEALTH  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06011395
• Other study ID #: 22HH7635
• Status: Enrolling by invitation
• Start date: August 30, 2023
• Est. completion date: August 30, 2025

Study information

• Verified date: August 2023
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1800
• Est. completion date: August 30, 2025
• Est. primary completion date: August 30, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Recurrence

Intervention

Device:
• Smartwatch
Activity tracker (step count, calories burned), heart rate monitor
• Imperial Healthy Hearts app
Digital cardiac rehabilitation smartphone application. Represents smart watch data and source of educational materials for cardiac rehabilitiation programme.

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uptake of cardiac rehabilitation	Percentage uptake of cardiac rehabilitation programme (of those that are eligible)	12 months
Secondary	Quality of life assessment (EQ-5D-5L)	Patient quality of life as measured by the EQ-5D-5L instrument	12 months