Post-stroke smartphone screening for atrial fibrillation
| ISRCTN | ISRCTN10238762 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10238762 |
| IRAS number | 299122 |
| Secondary identifying numbers | IRAS 299122 |
- Submission date
- 18/06/2021
- Registration date
- 31/08/2021
- Last edited
- 11/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Atrial fibrillation (AF) is the most common heart rhythm disturbance. Individuals with atrial fibrillation have an increased risk of developing strokes. Individuals with atrial fibrillation related strokes could still have their atrial fibrillation undiagnosed and be at risk of further strokes. Our smartphone application could help to identify atrial fibrillation early and therefore help them to get treatment early to prevent future strokes.
Aims:
1. To evaluate the use of our smartphone application, Fibricheck in atrial fibrillation screening of post stroke patients.
2. To evaluate the participant experience and satisfaction of using the smartphone application, Fibricheck.
Who can participate?
Participants who have had a stroke in the last 6 months can participate if they do not have a diagnosis of atrial fibrillation. They must have access to a smartphone and cannot have a pacemaker already.
What does the study involve?
The study involves providing the above participants with a smartphone application called Fibricheck and a 3-month monitoring period prescription for the application. The participants will need to take photoplethysmography recordings with their smartphone twice daily for 3 months. The recordings will be reviewed for the detection of atrial fibrillation. They will also receive electronic questionnaires to fill 1 month and 3 months from the start of using the application. This questionnaire will assess application usability.
What are the possible benefits and risks of participating?
The possible benefits of participating are earlier identification of atrial fibrillation and earlier treatment for atrial fibrillation and therefore possible prevention of further AF related strokes or conditions. However, it is also possible there will be no direct benefit to the research participant. There are no foreseeable risks of participating in this study.
Where is the study run from?
West Middlesex University Hospital (UK)
When is the study starting and how long is it expected to run for?
March 2021 to December 2022
Who is funding the study?
Chelsea and Westminster plus charity (UK)
Who is the main contact?
Dr Pavidra Sivanandarajah (Pavidra.sivanandarajah1@nhs.net)
Contact information
Scientific
West Middlesex University Hospital
Twickenham Road
Isleworth
London
TW7 6AF
United Kingdom
| Phone | +44 (0)2083215336 |
|---|---|
| pavidra.sivanandarajah1@nhs.net |
Study information
| Study design | Prospective observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Smartphone atrial fibrillation testing post stroke |
| Study acronym | SMARTS project |
| Study objectives | The smartphone photoplethysmography application Fibricheck can increase atrial fibrillation detection rates in the post stroke population. |
| Ethics approval(s) | Approval 04/08/2021, London-Hampstead REC (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK; +44 (0)2071048340; hampstead.rec@hra.nhs.uk), ref: 21/PR/0899 |
| Health condition(s) or problem(s) studied | Atrial fibrillation |
| Intervention | Participants with a history of previous stroke in the last 6 months will be recruited. They must not already have a diagnosis of atrial fibrillation. They will receive a smartphone application called Fibricheck with a 3-month monitoring period prescription for the App. They will perform photoplethysmography recordings with their smartphone twice daily for 3 months. They will also receive electronic questionnaires to fill 1 month and 3 months from start of using the application. This questionnaire will assess application usability. The total follow up is 3 - 6 months. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Photophlethysmography detection of atrial fibrillation twice daily over 3 months |
| Secondary outcome measures | Assess the application usability using questionnaires |
| Overall study start date | 01/03/2021 |
| Completion date | 30/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 70 |
| Total final enrolment | 22 |
| Key inclusion criteria | 1. Aged 18 years old or above 2. Had a cryptogenic stroke within the last 6 months 3. Able to provide verbal or signed written informed consent 4. Access to smartphone |
| Key exclusion criteria | 1. Have already a diagnosis of atrial fibrillation prior to study enrolment 2. Unable to provide verbal or signed written informed consent 3. Below the age of 18 years old 4. Presence of cardiac electronic implantable device |
| Date of first enrolment | 01/09/2021 |
| Date of final enrolment | 16/09/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Twickenham Road
Isleworth
London
TW7 6AF
United Kingdom
Sponsor information
Hospital/treatment centre
Research and Development Office
Unit G3, Harbour Yard
Chelsea Harbour
London
TW7 6AF
England
United Kingdom
| Phone | +44 (0)2033166887 |
|---|---|
| damon.foster2@nhs.net | |
| Website | http://www.chelwest.nhs.uk/ |
"ROR" |
https://ror.org/02gd18467 |
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/07/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publicarion in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to confidentiality. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1 | 06/04/2021 | 05/08/2021 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
11/10/2022: The following changes were made to the trial record:
1. The overall end date was changed from 30/09/2022 to 30/12/2022.
2. The recruitment end date was changed from 01/09/2022 to 16/09/2022.
3. The plain English summary was updated to reflect these changes.
4. The total final enrolment was added.
05/08/2021: Uploaded protocol (not peer-reviewed) as an additional file.
05/08/2021: Trial's existence confirmed by London-Hampstead REC.
