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

NCT06011395 | Not Yet Recruiting

• 1 other identifier: 22HH7635
• Study Type: observational
• Target: 1,800
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Keywords

Cardiac rehabilitation; Prevention; Digital health; Smart wearables; Remote patient monitoring

Outcome Measures

Primary Outcomes (1)

• Uptake of cardiac rehabilitation

  Percentage uptake of cardiac rehabilitation programme (of those that are eligible)

  12 months

Secondary Outcomes (1)

• Quality of life assessment (EQ-5D-5L)

  12 months

Interventions

Smartwatch DEVICE

Activity tracker (step count, calories burned), heart rate monitor

Imperial Healthy Hearts app DEVICE

Digital cardiac rehabilitation smartphone application. Represents smart watch data and source of educational materials for cardiac rehabilitiation programme.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients at Imperial College Healthcare NHS Trust eligible for cardiac rehabilition

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College Healthcare NHS Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Nicholas S Peters, MD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mihir Kelshiker, MD

CONTACT

+447590673758; mihir.kelshiker10@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 25, 2023
• Study Start: January 30, 2025
• Primary Completion: March 2, 2026
• Study Completion: March 2, 2026
• Last Updated: October 18, 2024

Record last verified: 2024-10

Locations

GB (1)