Smart Watch Insights for Prevention of Exacerbations and Enhance Rehabilitation - Movement Study

NCT ID: NCT06011356

Last Updated: 2024-10-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-30
• Study Completion Date: 2026-08-30

Brief Summary

Aims of the study:

1. To deliver a scalable wellbeing programme to the local population of Imperial College Healthcare NHS Trust, focusing on movement.

2. To describe the natural history of long-term conditions using digital data from a smartwatch.

3. To identify digital information that is routinely collected by a smart watch that can be used to predict outcomes in patients with long term conditions.

4. To identify factors that determine whether participants engage with and improve in a movement programme.

Adult patients who are registered to the Imperial NHS Care Information Exchange (CIE), an NHS patient-facing electronic health record, are eligible to participate in the study. Participants will receive a smart watch for self-monitoring of their movement and wellbeing and be asked to wear the device as much as possible. They will be asked to download a smartphone application called Connected Life, which displays movement and information on heart rate, breathing and oxygen levels to both the participant and the research team (digital data). Participants will receive secure login details for the Connected Life application from the research team, to ensure data privacy. The research team will look at participants' health records, and attempt to identify associations between the digital data and clinical information. This will allow the research team to identify digital data that predicts the onset and natural history of long term conditions, which may potentially allow for earlier diagnosis for future patients. The primary outcome of the study is the identification of trends in movement based on step-count data recorded by the smartwatch.

Conditions

Cardiovascular Diseases; Non-Alcoholic Fatty Liver Disease; Respiratory Disease; Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Smartwatch

Activity tracker (step count, calories burned), measures heart rate, heart variability and other physiological variables.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Aged over 18 years
• Registered with the patient-facing electronic health record (Care Information Exchange)

Exclusion Criteria

• Unwilling or unable to provide informed consent
• Arm or wrist injury or condition prohibiting the safe use of a smartwatch
• Any visual impairment preventing the use of the smartwatch or smartphone application.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicholas S Peters, MD

Role: PRINCIPAL_INVESTIGATOR

Imperial College Healthcare NHS Trust

Locations

Imperial College Healthcare NHS Trust

London, United Kingdom (+44), United Kingdom

Countries

United Kingdom

Other Identifiers

22HH7499

Identifier Type: -

Identifier Source: org_study_id