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

Sponsor
Imperial College London (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT06011356
Collaborator
(none)
1,000
1
36
27.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Smartwatch

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Smart Watch Insights for Prevention of Exacerbations and Enhance Rehabilitation - Movement Study
Anticipated Study Start Date :
Aug 30, 2023
Anticipated Primary Completion Date :
Aug 30, 2026
Anticipated Study Completion Date :
Aug 30, 2026

Outcome Measures

Primary Outcome Measures

  1. Step count [24 months]

    Change and trends in step count

Secondary Outcome Measures

  1. Quality of life (EQ-5D-5L) [24 months]

    Change in quality of life as measured by the EQ-5D-5L questionnaire

  2. Patient Activation Measure (PAM) [24 months]

    Change in patient engagement and confidence over own health, as measured by the Patient Activation Measure

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Imperial College Healthcare NHS Trust London United Kingdom (+44) United Kingdom NW25QS

Sponsors and Collaborators

  • Imperial College London

Investigators

  • Principal Investigator: Nicholas S Peters, MD, Imperial College Healthcare NHS Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Imperial College London
ClinicalTrials.gov Identifier:
NCT06011356
Other Study ID Numbers:
  • 22HH7499
First Posted:
Aug 25, 2023
Last Update Posted:
Aug 25, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Imperial College London
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 25, 2023