Promoting physical activity and exercise after stroke using a text messaging intervention (Phase 2)
| ISRCTN | ISRCTN13704805 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13704805 |
| IRAS number | 291668 |
| Secondary identifying numbers | 2-003-2021, IRAS 291668 |
- Submission date
- 30/03/2021
- Registration date
- 14/04/2021
- Last edited
- 10/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
A stroke is a serious life-threatening medical condition that occurs when the blood supply to part of the brain is cut off. The damage this causes can affect the way your body works, as well as how you think, feel and communicate.
Rehabilitation delivered by physiotherapists is the main intervention for physical recovery immediately post-stroke. After rehabilitation, survivors are signposted to community-based exercise opportunities, walking groups and gyms, and are prescribed home exercises to support recovery. Despite this, 50% of stroke survivors report feeling abandoned and struggle with adherence to exercises for ongoing recovery. Short Message Service (SMS) messages for the delivery of tailored behavioural interventions may support exercise and physical activity adherence after rehabilitation.
The aim of this study (Phase 2) is to pilot test and refine an SMS intervention ready for evaluation in a future feasibility randomised controlled trial. The novel, theoretically informed behaviour change intervention, comprising a series of SMS messages, to support community-dwelling stroke survivors to adhere to personal exercise and PA goals for recovery was co-designed with stroke survivors and rehabilitation professionals in Phase 1.
Who can participate?
Patients aged over 18 years who have had a stroke and are nearing the end of their community rehabilitation period.
What does the study involve?
The study will pilot test and refine the novel SMS intervention in two waves, by delivering it to 44 stroke survivors who are at the end of rehabilitation. Potential participants, identified by rehabilitation therapists, will receive the SMS intervention over 12 weeks. The intervention will be pilot-tested with 14 stroke survivors in Wave 1, then following revisions and refinement, will then be tested with 30 participants in Wave 2.
The personalised SMS messages will be sent by an automated computer system which will be programmed to send out text messages to participants’ mobile phones in a predetermined sequence.
Participants will be interviewed by telephone to ascertain their views on the acceptability and usefulness of the intervention. The intervention will be refined using the Collaborative Working Group (CWG) methodology, a formalised stakeholder consultation process. The CWG comprises the research team, stroke survivors, health professionals and academics. A structured decision-making process will be used to revise and refine the intervention, using data available throughout the study (scientific evidence, interview data and field notes). Amendments, made at the end of Phase 2 will provide a final intervention to be tested in a full randomised controlled trial
What are the possible benefits and risks of participating?
The researchers cannot guarantee any benefits, but exercise and physical activity may help with recovery after stroke.
The participants may have impaired mobility and/or balance problems. The greatest potential risk, therefore, is falling. Participants will have been assessed by a health professional (usually a physiotherapist) before being invited to take part in the study, and will only be invited if it is deemed safe for them to take part. They will also receive information on how to reduce the risk of falls and how to manage if they have a fall.
Risks posed by COVID-19 are minimised, as all contact with participants will be by telephone and text communication.
When is the study starting and how long is it expected to run for?
October 2020 to February 2023
Where is the study run from?
The study is run from the University of Dundee, Scotland. Collaborators are based at the University of New Brunswick and the University of St Andrews (UK).
Who is funding the study?
The Chief Scientist Office, Scottish Government, UK
Who is the main contact?
Dr Jacqui Morris
J.Y.Morris @dundee.ac.uk
Contact information
Scientific
School of Health Sciences
University of Dundee
Dundee
DD1 4HJ
United Kingdom
 ORCID ID |
0000-0002-9130-686X |
|---|---|
| Phone | +44 (0)7565 014511 |
| j.y.morris@dundee.ac.uk |
Study information
| Study design | Interventional non-randomized development study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Home |
| Study type | Other |
| Participant information sheet | ISRCTN13704805_PIS_v3.0_15Mar2021.pdf |
| Scientific title | Keeping Active with Texting after Stroke |
| Study acronym | KATS |
| Study objectives | A behaviour change SMS intervention, delivered over 12 weeks, will support community dwelling stroke survivors to continue with exercise and physical activities to improve recovery, physical activity levels and quality of life after discharge from rehabilitation. |
| Ethics approval(s) | Approved 18/03/2021, North of Scotland Research Ethics Service (Summerfield House, 2 Eday Road, Aberdeen, AB15 6RE, UK; +44 (0)1224 558458;nosres@nhs.net), ref: 21/NS/0028 |
| Health condition(s) or problem(s) studied | Maintenance of physical activity in people who have had a stroke and are coming to the end of community rehabilitation |
| Intervention | This is an intervention development study to co-produce an SMS behaviour change intervention in conjunction with stroke survivors and health professionals. The study will undertake preliminary testing of this novel intervention, which will be further developed and refined during the study using formalised stakeholder engagement methods. The novel SMS intervention will be delivered to the stroke survivors over a 12-week period. Participants will receive at least one text message per day throughout the intervention period. The intervention is designed to support stroke survivors to continue with rehabilitation exercise and physical activities post-rehabilitation. This is an intervention development study, so no comparator group will be used. |
| Intervention type | Behavioural |
| Primary outcome measure | Engagement of participants with the SMS intervention, assessed by their text message responses to the intervention, telephone interviews at six weeks post-recruitment and at the end of the intervention period. Interviews will seek participants' views on the intervention to refine it for future testing in a randomised controlled trial. |
| Secondary outcome measures | Acceptability of the intervention, assessed using semi-structured interviews six weeks post-recruitment and at the end of the intervention period |
| Overall study start date | 01/10/2020 |
| Completion date | 28/02/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 44 |
| Total final enrolment | 44 |
| Key inclusion criteria | Stroke survivors who: 1. Live in the community 2. Are over 18 years of age 3. Have access to and can use a mobile phone 4. Can provide informed consent 5. Have no contraindications to increasing physical activity 6. Have discussed goal setting with their therapist before discharge from rehabilitation services |
| Key exclusion criteria | Stroke survivors who: 1. Are unable to participate in the study over a 12-week period 2. Have medical conditions contraindicating increased physical activity or specific rehabilitation exercises 3. Cannot communicate verbally (over the telephone or face to face). These people will be excluded for this phase of the study because it involves providing informed consent, discussing the content of the intervention and giving advice on how to improve it, completing questionnaires by telephone |
| Date of first enrolment | 19/04/2021 |
| Date of final enrolment | 30/09/2022 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
11 Airlie Place
Dundee
DD14HJ
United Kingdom
Sponsor information
University/education
TASC Research & Development Office
Ninewells Hospital &Medical School
Dundee
DD1 9SY
Scotland
United Kingdom
| Phone | +44 (0)1382 383877 |
|---|---|
| TASCgovernance@dundee.ac.uk | |
| Website | http://www.tasc-research.org.uk |
"ROR" |
https://ror.org/03h2bxq36 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Chief Scientist Office, Scottish Government Health Directorate CSO, Chief Scientist Office, Scottish Government Health Directorates, Chief Scientist Office of the Scottish Government Health Directorates, Scottish Government Health and Social Care Directorate of the Chief Scientist Office, Scottish Government Health Directorate Chief Scientist Office, The Chief Scientist Office, CSO
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The researchers intend to publish a paper on the development of the intervention in a scientific peer-reviewed journal, and will disseminate their findings at academic conferences, NHS events, and within our local research community. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Jacqui Morris (j.y.morris@dundee.ac.uk). Type of data: structured Interview transcripts. The researchers will be using the data to inform future studies, so envisage that it would be two years after the end of the study, 31/07/2024, before they would be willing to share the data, and it will be available for five years thereafter. Only researchers who are undertaking intervention development studies of behavioural interventions after stroke, and wish to investigate appropriate adaptations for intervention acceptability by undertaking secondary analysis, may access the data on request to the principal investigator, for qualitative data analysis using framework method or other relevant analysis approaches. Consent was obtained in the participant consent forms by asking the participant to agree to the statement “information about me may be used in other research, but the information will not use my name.” All transcripts will be anonymised with any identifying information removed. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version v3.0 | 15/03/2021 | 04/05/2021 | No | Yes |
| Plain English results | 06/04/2023 | No | Yes | ||
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | Development of intervention | 23/06/2023 | 19/10/2023 | Yes | No |
| Other publications | Qualitative study | 06/07/2023 | 19/10/2023 | Yes | No |
| Protocol file | version 1.0 | 16/02/2021 | 21/06/2024 | No | No |
| Basic results | 09/01/2025 | No | No | ||
| Results article | 08/02/2025 | 10/02/2025 | Yes | No |
Additional files
Editorial Notes
10/02/2025: Publication reference added.
09/01/2025: Basic results uploaded.
21/06/2024: IRAS number added. Protocol uploaded. The intention to publish date has been changed from 01/09/2023 to 31/12/2024.
19/10/2023: Publication references added.
06/04/2023: The following changes have been made:
1. A plain English results file has been uploaded.
2. The intention to publish date has been changed from 01/02/2023 to 01/09/2023.
30/09/2022: Total final enrolment added.
16/08/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/04/2022 to 30/09/2022.
2. The overall trial end date was changed from 31/08/2022 to 28/02/2023.
20/05/2021: Internal review.
04/05/2021: The participant information sheet was uploaded as an additional file.
31/03/2021: Trial's existence confirmed by North of Scotland Research Ethics Service.
