Cardiovascular DiseasesSWIPER-MOVESNCT06011356
Smart Watch Insights for Prevention of Exacerbations and Enhance Rehabilitation - Movement Study
An observational study of Cardiovascular Diseases and Non-Alcoholic Fatty Liver Disease, run by Imperial College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Non-Alcoholic Fatty Liver Disease, Respiratory Disease
- What is being tested?
- Smartwatch
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Aug 2023to 30 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Aged over 18 years
- Registered with the patient-facing electronic health record (Care Information Exchange)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College Healthcare NHS Trust
London, United Kingdom (+44), NW25QS
About this study
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.
- Being tested
- Smartwatch
- Keywords
- Digital health, Smart wearable, Population health, Digital biomarkers
- Medical subject headings
- Cardiovascular Diseases, Non-alcoholic Fatty Liver Disease, Respiration Disorders, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartwatchDevice
Activity tracker (step count, calories burned), measures heart rate, heart variability and other physiological variables.
What is being measured
The primary outcome is the main question the study is designed to answer.
Step count
Change and trends in step count
Measured: 24 months
Secondary outcomes (2)
Quality of life (EQ-5D-5L)
Change in quality of life as measured by the EQ-5D-5L questionnaire
Measured: 24 months
Patient Activation Measure (PAM)
Change in patient engagement and confidence over own health, as measured by the Patient Activation Measure
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start30 Aug 2023
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas S Peters, MD, Principal investigator, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011356
- Sponsor's protocol ID
- 22HH7499
- Acronym
- SWIPER-MOVES
- Status last verified
- Oct 2024
- First submitted
- 21 Aug 2023
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Watch Insights for Prevention of Exacerbations and Enhance Rehabilitation - Movement Study
- ClinicalTrials.gov ID
- NCT06011356
- Acronym / sponsor ID
- SWIPER-MOVES / 22HH7499
- Keywords
- Digital health, Smart wearable, Population health, Digital biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Aged over 18 years
- Registered with the patient-facing electronic health record (Care Information Exchange)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmartwatchActivity tracker (step count, calories burned), measures heart rate, heart variability and other physiological variables. | Device | – |
Primary outcome
Step count
Time frame: 24 months
Change and trends in step count
2 secondary outcomes
Quality of life (EQ-5D-5L)
Time frame: 24 months
Patient Activation Measure (PAM)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas S Peters, MD principal investigator
Imperial College Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Non-Alcoholic Fatty Liver Disease, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Step count (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.