Condition category
Circulatory System
Date applied
14/12/2010
Date assigned
14/12/2010
Last edited
27/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Claire Schwartz

ORCID ID

Contact details

Primary Care Clinical Sciences
School of Health and Population Sciences
Edgbaston
Birmingham
B15 2TT
United Kingdom
c.l.schwartz@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

9361

Study information

Scientific title

Acronym

TASMIN-SR

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.

Ethics approval

MREC approved, 30/09/2010, ref: 10/H1013/60

Study design

Multicentre randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/12/2010

Overall trial end date

31/07/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 540; UK sample size: 540

Participant 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

Recruitment start date

01/12/2010

Recruitment end date

31/07/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Primary Care Clinical Sciences
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

Department of Primary Care and General Practice
Primary Care Clinical Sciences Building
Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

http://www.birmingham.ac.uk/index.aspx

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR) (ref: RP-PG-0606-1153)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23522245
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25157723

Publication citations

  1. Protocol

    O'Brien C, Bray EP, Bryan S, Greenfield SM, Haque MS, Hobbs FD, Jones MI, Jowett S, Kaambwa B, Little P, Mant J, Penaloza C, Schwartz C, Shackleford H, Varghese J, Williams B, McManus RJ, Targets and self-management for the control of blood pressure in stroke and at risk groups (TASMIN-SR): protocol for a randomised controlled trial., BMC Cardiovasc Disord, 2013, 13, 21, doi: 10.1186/1471-2261-13-21.

  2. Results

    McManus RJ, Mant J, Haque MS, Bray EP, Bryan S, Greenfield SM, Jones MI, Jowett S, Little P, Penaloza C, Schwartz C, Shackleford H, Shovelton C, Varghese J, Williams B, Hobbs FD, Effect of self-monitoring and medication self-titration on systolic blood pressure in hypertensive patients at high risk of cardiovascular disease: the TASMIN-SR randomized clinical trial., JAMA, 2014, 312, 8, 799-808, doi: 10.1001/jama.2014.10057.

Additional files

Editorial Notes