title: Targets and self-management for the control of blood pressure in stroke and at risk groups (TASMIN-SR): protocol for a randomised controlled trial.
abstract: BACKGROUND
  Self-monitoring of hypertension with self-titration of antihypertensives (self-management) results in lower systolic blood pressure for at least one year. However, few people in high risk groups have been evaluated to date and previous work suggests a smaller effect size in these groups. This trial therefore aims to assess the added value of self-management in high risk groups over and above usual care.
  
  
  METHODS
  The targets and self-management for the control of blood pressure in stroke and at risk groups (TASMIN-SR) trial will be a pragmatic primary care based, unblinded, randomised controlled trial of self-management of blood pressure (BP) compared to usual care. Eligible patients will have a history of stroke, coronary heart disease, diabetes or chronic kidney disease and will be recruited from primary care. Participants will be individually randomised to either usual care or self-management. The primary outcome of the trial will be difference in office SBP between intervention and control groups at 12 months adjusted for baseline SBP and covariates. 540 patients will be sufficient to detect a difference in SBP between self-management and usual care of 5 mmHg with 90% power. Secondary outcomes will include self-efficacy, lifestyle behaviours, health-related quality of life and adverse events. An economic analysis will consider both within trial costs and a model extrapolating the results thereafter. A qualitative analysis will gain insights into patients' views, experiences and decision making processes.
  
  
  CONCLUSIONS
  The results of the trial will be directly applicable to primary care in the UK. If successful, self-management of blood pressure in people with stroke and other high risk conditions would be applicable to many hundreds of thousands of individuals in the UK and beyond.
  
  
  BACKGROUND
  ISRCTN87171227.
authors.affiliation: Primary Care Clinical Sciences, NIHR School for Primary Care Research, University of Birmingham, Edgbaston, Birmingham, UK.
authors.forename: Claire
authors.initials: C
authors.lastname: O'Brien
authors.forename: Emma P
authors.initials: EP
authors.lastname: Bray
authors.forename: Stirling
authors.initials: S
authors.lastname: Bryan
authors.forename: Sheila M
authors.initials: SM
authors.lastname: Greenfield
authors.forename: M Sayeed
authors.initials: MS
authors.lastname: Haque
authors.forename: F D Richard
authors.initials: FD
authors.lastname: Hobbs
authors.forename: Miren I
authors.initials: MI
authors.lastname: Jones
authors.forename: Sue
authors.initials: S
authors.lastname: Jowett
authors.forename: Billingsley
authors.initials: B
authors.lastname: Kaambwa
authors.forename: Paul
authors.initials: P
authors.lastname: Little
authors.forename: Jonathan
authors.initials: J
authors.lastname: Mant
authors.forename: Cristina
authors.initials: C
authors.lastname: Penaloza
authors.forename: Claire
authors.initials: C
authors.lastname: Schwartz
authors.forename: Helen
authors.initials: H
authors.lastname: Shackleford
authors.forename: Jinu
authors.initials: J
authors.lastname: Varghese
authors.forename: Bryan
authors.initials: B
authors.lastname: Williams
authors.forename: Richard J
authors.initials: RJ
authors.lastname: McManus
mesh_terms: D000959:Antihypertensive Agents / Q000008:administration & dosage* / Q000191:economics; D001794:Blood Pressure / Q000187:drug effects*; D018660:Blood Pressure Monitoring, Ambulatory; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D016527:Drug Costs; D015438:Health Behavior; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D006973:Hypertension / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy* / Q000191:economics / Q000503:physiopathology; D011237:Predictive Value of Tests; D011320:Primary Health Care; D012107:Research Design; D012307:Risk Factors; D040242:Risk Reduction Behavior; D012648:Self Care; D020377:Self Efficacy; D020521:Stroke / Q000191:economics / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom
chemical_list: D000959:Antihypertensive Agents