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

Diabetes Clinical Trial

— SWIPER-MOVES  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06011356
• Other study ID #: 22HH7499
• Status: Enrolling by invitation
• Start date: August 30, 2023
• Est. completion date: August 30, 2026

Study information

• Verified date: August 2023
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: August 30, 2026
• Est. primary completion date: August 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes
• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare NHS Trust	London	United Kingdom (+44)

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Step count	Change and trends in step count	24 months
Secondary	Quality of life (EQ-5D-5L)	Change in quality of life as measured by the EQ-5D-5L questionnaire	24 months
Secondary	Patient Activation Measure (PAM)	Change in patient engagement and confidence over own health, as measured by the Patient Activation Measure	24 months