Targets and self management for the control of blood pressure in stroke and other at-risk groups (TASMIN-SR): a randomised controlled trial
| ISRCTN | ISRCTN87171227 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87171227 |
| Secondary identifying numbers | 9361 |
- Submission date
- 14/12/2010
- Registration date
- 14/12/2010
- Last edited
- 27/08/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Claire Schwartz
Scientific
Scientific
Primary Care Clinical Sciences
School of Health and Population Sciences
Edgbaston
Birmingham
B15 2TT
United Kingdom
| c.l.schwartz@bham.ac.uk |
Study information
| Study design | Multicentre randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Scientific title | |
| Study acronym | TASMIN-SR |
| Study objectives | TASMIN-SR is a primary-care based, unblinded, randomised controlled trial of self-management of blood pressure consisting of self-monitoring with self-titration of anti-hypertensive medication in people with stroke and other at-risk conditions. Recruitment will be through the Primary Care Research Network, with patients invited to participate if they have a diagnosis of stroke/transient ischaemic attack (TIA), diabetes, chronic kidney disease (CKD3), coronary artery bypass graft (CABG), myocardial infarction (MI) or angina, and their blood pressure is above 130/80 mmHg. Patients will be randomised to either self-management of blood pressure or usual care. The main research questions are: 1. Does self-management of blood pressure (BP) result in better control of BP in people with Stroke and other at-risk conditions compared to usual care? 2. Is self-management of BP in people with Stroke and other at-risk conditions acheivable in routine practice and is it acceptable to patients? 3. What is the relationship between self-management of BP, self-efficacy, lifestyle behaviours, patient attitudes to health and health care and use of other self-care strategies in people with Stroke and other at-risk conditions? 4. Is self-management of BP in people with Stroke and other at-risk conditions cost effective? Please note that as of 04/02/2013, the anticipated end date for this study was updated from 31/08/2011 to 31/07/2013. |
| Ethics approval(s) | MREC approved, 30/09/2010, ref: 10/H1013/60 |
| Health condition(s) or problem(s) studied | Topic: Primary Care Research Network for England, Cardiovascular; Subtopic: Not Assigned, Cardiovascular (all Subtopics); Disease: Cardiovascular, All Diseases |
| Intervention | Self management of BP: Patients will monitor their own blood pressure at home each month, and follow a pre-determined titration plan if their BP is above target over two consecutive months. Follow-up length: 12 months Study entry: single randomisation only |
| Intervention type | Other |
| Primary outcome measure | Systolic blood pressure, measured at baseline, 6 months and 12 months |
| Secondary outcome measures | 1. Adverse events, measured at baseline, 6 months and 12 months 2. Anxiety, measured at baseline, 6 months and 12 months 3. Attitudes to health and health care, measured at baseline, 6 months and 12 months 4. Blood pressure measurement preference, measured at baseline, 6 months and 12 months 5. Diastolic Blood pressure, measured at baseline, 6 months and 12 months 6. Health related quality of life, measured at baseline, 6 months and 12 months 7. Lifestyle behaviours, measured monthly 8. Pulse rate, measured at baseline, 6 months and 12 months 9. Reasons for non-participation, measured at invitation/baseline 10. Self-care strategies, measured at baseline, 6 months and 12 months 11. Self-management self-efficacy, measured monthly 12. Time at target blood pressure, measured at baseline, 6 months and 12 months |
| Overall study start date | 01/12/2010 |
| Completion date | 31/07/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned sample size: 540; UK sample size: 540 |
| Key inclusion criteria | 1. Aged above 35 years, either sex 2. Have had a diagnosis of stroke/TIA, diabetes, CKD3, MI, angina, or CABG 3. Systolic blood pressure greater than 130/80 mmHg |
| Key exclusion criteria | 1. Inability to self-monitor such as dementia or score over 10 on the short orientation memory concentration test (and with no carer support) 2. Postural hypotension (fall in SBP greater than 20 mmHg after 1 minute standing) 3. Taking more than three anti-hypertensive medications 4. Taking part in a current blood pressure study or previously taken part in TASMINH2 5. Terminal disease 5. Pregnant 6. Blood pressure not managed by the GP and acute cardiovascular event in the last 3 months |
| Date of first enrolment | 01/12/2010 |
| Date of final enrolment | 31/07/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Primary Care Clinical Sciences
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Sponsor information
University of Birmingham (UK)
University/education
University/education
Department of Primary Care and General Practice
Primary Care Clinical Sciences Building
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
| Website | http://www.birmingham.ac.uk/index.aspx |
|---|---|
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR) (ref: RP-PG-0606-1153)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 23/03/2013 | Yes | No | |
| Results article | results | 27/08/2014 | Yes | No |
