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NCT Number: NCT06011395

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Imperial College Healthcare NHS Trust

London, United Kingdom

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Uptake of cardiac rehabilitation

    Time frame: 12 months

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

Secondary outcomes

  1. Quality of life assessment (EQ-5D-5L)

    Time frame: 12 months

    Patient quality of life as measured by the EQ-5D-5L instrument

Study contacts

Contact information is provided by the study sponsor or research team.

Mihir Kelshiker, MD

CONTACT

[email protected]

+447590673758

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study title

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

Acronym: SWIPER-REHAB

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 25, 2023
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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