Cardiovascular DiseasesSWIPER-REHABNCT06011395
Smart Wearable Insights to Prevent Exacerbations and Recurrence - Rehabilitation Study: SWIPER-REHAB
An observational study of Cardiovascular Diseases, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Aims of the study: To measure the rate of completion of a digital cardiac rehabilitation programme at Imperial College Healthcare NHS Trust (ICHNT) To measure the health economic impact of a digital cardiac rehabilitation programme at ICHNT Any adult patient eligible for ICHNT cardiac rehabilitation (CR) programmes is… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Smartwatch and Imperial Healthy Hearts app
- Type of treatment
- Medical device
- How many people
- 1,800 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jan 2025to 2 Mar 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
- Adult, Older adult
Study population: Patients at Imperial College Healthcare NHS Trust eligible for cardiac rehabilition
Who may be able to join
- Age 18 years or above
- Able to give informed consent
- Eligible for Cardiac Rehabilitation programme
Who cannot join
- Any wrist wound, skin pathology or other feature that would prohibit the wearing of a smartwatch
- Any visual impairment preventing the use of the Fitbit or smartphone application.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Smart Watch Insights to Prevent Exacerbations and Recurrence - Rehabilitation Study: SWIPER-REHAB
Aims of the study:
- To measure the rate of completion of a digital cardiac rehabilitation programme at Imperial College Healthcare NHS Trust (ICHNT)
- To measure the health economic impact of a digital cardiac rehabilitation programme at ICHNT
Read more
Any adult patient eligible for ICHNT cardiac rehabilitation (CR) programmes is eligible to participate. Participants will receive a commercially available smart watch and be asked to wear the device as much as possible. In addition, they will be asked to download a smartphone application called 'Imperial Healthy Hearts', which displays movement and information on heart rate, breathing and oxygen levels to both the participant and the research team (digital data). The Healthy Hearts app also allows the direct care team to provide educational materials to patients as part of their routine care.
The clinical content and structure of the CR programme is determined by the clinical CR team, and does not deviate from established local and national standards and practices.
Researchers will capture physiological data such as heart rate, respiratory rate, blood pressure (where available) and oxygen saturation (where available) via the Healthy Hearts platform. Researchers will also capture clinical information from the electronic health record, and will compare CR programme uptake and completion rates with historical data and national targets.
- Conditions
- Cardiovascular Diseases
- Being tested
- Smartwatch, Imperial Healthy Hearts app
- Keywords
- Cardiac rehabilitation, Prevention, Digital health, Smart wearables, Remote patient monitoring
- Medical subject headings
- Cardiovascular Diseases
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), heart rate monitor
Imperial Healthy Hearts appDevice
Digital cardiac rehabilitation smartphone application. Represents smart watch data and source of educational materials for cardiac rehabilitiation programme.
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of cardiac rehabilitation
Percentage uptake of cardiac rehabilitation programme (of those that are eligible)
Measured: 12 months
Secondary outcomes (1)
Quality of life assessment (EQ-5D-5L)
Patient quality of life as measured by the EQ-5D-5L instrument
Measured: 12 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 Jan 2025 (estimated)
- Primary completion2 Mar 2026 (estimated)
- Study completion2 Mar 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
- 1,800 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 London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011395
- Sponsor's protocol ID
- 22HH7635
- Acronym
- SWIPER-REHAB
- 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 to Prevent Exacerbations and Recurrence - Rehabilitation Study: SWIPER-REHAB
- ClinicalTrials.gov ID
- NCT06011395
- Acronym / sponsor ID
- SWIPER-REHAB / 22HH7635
- Conditions
- Cardiovascular Diseases
- Keywords
- Cardiac rehabilitation, Prevention, Digital health, Smart wearables, Remote patient monitoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 30 Jan 2025 (estimated)
- Primary completion
- 2 Mar 2026 (estimated)
- Study completion
- 2 Mar 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 measure the rate of completion of a digital cardiac rehabilitation programme at Imperial College Healthcare NHS Trust (ICHNT)
- To measure the health economic impact of a digital cardiac rehabilitation programme at ICHNT
Any adult patient eligible for ICHNT cardiac rehabilitation (CR) programmes is eligible to participate. Participants will receive a commercially available smart watch and be asked to wear the device as much as possible. In addition, they will be asked to download a smartphone application called 'Imperial Healthy Hearts', which displays movement and information on heart rate, breathing and oxygen levels to both the participant and the research team (digital data). The Healthy Hearts app also allows the direct care team to provide educational materials to patients as part of their routine care.
The clinical content and structure of the CR programme is determined by the clinical CR team, and does not deviate from established local and national standards and practices.
Researchers will capture physiological data such as heart rate, respiratory rate, blood pressure (where available) and oxygen saturation (where available) via the Healthy Hearts platform. Researchers will also capture clinical information from the electronic health record, and will compare CR programme uptake and completion rates with historical data and national targets.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients at Imperial College Healthcare NHS Trust eligible for cardiac rehabilition
Key inclusion criteria (3 listed)
- Age 18 years or above
- Able to give informed consent
- Eligible for Cardiac Rehabilitation programme
Key exclusion criteria (2 listed)
- Any wrist wound, skin pathology or other feature that would prohibit the wearing of a smartwatch
- Any visual impairment preventing the use of the Fitbit 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), heart rate monitor | Device | – |
| Imperial Healthy Hearts appDigital cardiac rehabilitation smartphone application. Represents smart watch data and source of educational materials for cardiac rehabilitiation programme. | Device | – |
Primary outcome
Uptake of cardiac rehabilitation
Time frame: 12 months
Percentage uptake of cardiac rehabilitation programme (of those that are eligible)
1 secondary outcome
Quality of life assessment (EQ-5D-5L)
Time frame: 12 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 London
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, 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 3 inclusion and 2 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?
Contact Mihir Kelshiker, MD (+447590673758, mihir.kelshiker10@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of cardiac rehabilitation (time frame: 12 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.