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

NCT06011356 | Active Not Recruiting

• 1 other identifier: 22HH7499
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Aims of the study:

1. 1.To deliver a scalable wellbeing programme to the local population of Imperial College Healthcare NHS Trust, focusing on movement.
2. 2.To describe the natural history of long-term conditions using digital data from a smartwatch.
3. 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. 4.To identify factors that determine whether participants engage with and improve in a movement programme.

Conditions

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

Keywords

Digital health; Smart wearable; Population health; Digital biomarkers

Outcome Measures

Primary Outcomes (1)

• Step count

  Change and trends in step count

  24 months

Secondary Outcomes (2)

• Quality of life (EQ-5D-5L)

  24 months

• Patient Activation Measure (PAM)

  24 months

Interventions

Smartwatch DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will recruit study participants from patients registered to the Imperial College Healthcare NHS Trust Care Information Exchange (CIE), a patient-facing electronic health record. Patients on CIE have already provided consent to be approached for NHS research.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College Healthcare NHS Trust

London, United Kingdom (+44), NW25QS, United Kingdom

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Non-alcoholic Fatty Liver Disease; Respiration Disorders; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Respiratory Tract Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Nicholas S Peters, MD

  Imperial College Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 25, 2023
• Study Start: August 30, 2023
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: October 18, 2024

Record last verified: 2024-10

Locations

GB (1)