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
Protocol serial number	9361
Sponsor	University of Birmingham (UK)
Funder	National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR) (ref: RP-PG-0606-1153)

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

Primary Care Clinical Sciences
School of Health and Population Sciences
Edgbaston
Birmingham
B15 2TT
United Kingdom

Email	c.l.schwartz@bham.ac.uk

Study information

Primary study design	Interventional
Study design	Multicentre randomised interventional treatment trial
Secondary study design	Randomised controlled trial
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(s)	Systolic blood pressure, measured at baseline, 6 months and 12 months
Key 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
Completion date	31/07/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Primary Care Clinical Sciences

Birmingham
B15 2TT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	27/08/2014		Yes	No
Protocol article	protocol	23/03/2013		Yes	No