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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 10.1186/ISRCTN87171227
ClinicalTrials.gov identifier
EudraCT number
Public title Targets and self management for the control of blood pressure in stroke and other at-risk groups (TASMIN-SR): a randomised controlled trial
Scientific title
Acronym TASMIN-SR
Serial number at source 9361
Study hypothesis 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.
Lay summary Not provided at time of registration
Ethics approval MREC approved, 30/09/2010, ref: 10/H1013/60
Study design Multicentre randomised interventional treatment trial
Countries of recruitment United Kingdom
Disease/condition/study domain Topic: Primary Care Research Network for England, Cardiovascular; Subtopic: Not Assigned, Cardiovascular (all Subtopics); Disease: Cardiovascular, All Diseases
Participants - 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
Participants - 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
Anticipated start date 01/12/2010
Anticipated end date 31/07/2013
Status of trial Completed
Patient information material
Target number of participants Planned sample size: 540; UK sample size: 540
Interventions 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
Primary outcome measure(s) Systolic blood pressure, measured at baseline, 6 months and 12 months
Secondary outcome measure(s) 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
Sources of funding National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR) (ref: RP-PG-0606-1153)
Trial website
Publications 2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23522245
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25157723
Contact name Dr  Claire  Schwartz
  Address Primary Care Clinical Sciences
School of Health and Population Sciences
Edgbaston
  City/town Birmingham
  Zip/Postcode B15 2TT
  Country United Kingdom
  Email c.l.schwartz@bham.ac.uk
Sponsor University of Birmingham (UK)
  Address Department of Primary Care and General Practice
Primary Care Clinical Sciences Building
Edgbaston
  City/town Birmingham
  Zip/Postcode B15 2TT
  Country United Kingdom
  Sponsor website: http://www.birmingham.ac.uk/index.aspx
Date applied 14/12/2010
Last edited 27/08/2014
Date ISRCTN assigned 14/12/2010
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