- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06011356
Smart Watch Insights for Prevention of Exacerbations and Enhance Rehabilitation - Movement Study (SWIPER-MOVES)
Aims of the study:
- To deliver a scalable wellbeing programme to the local population of Imperial College Healthcare NHS Trust, focusing on movement.
- To describe the natural history of long-term conditions using digital data from a smartwatch.
- 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.
- 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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
United Kingdom (+44)
-
London, United Kingdom (+44), United Kingdom, NW25QS
- Imperial College Healthcare NHS Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Step count
Time Frame: 24 months
|
Change and trends in step count
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life (EQ-5D-5L)
Time Frame: 24 months
|
Change in quality of life as measured by the EQ-5D-5L questionnaire
|
24 months
|
|
Patient Activation Measure (PAM)
Time Frame: 24 months
|
Change in patient engagement and confidence over own health, as measured by the Patient Activation Measure
|
24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nicholas S Peters, MD, Imperial College Healthcare NHS Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22HH7499
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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