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Tailored Interventions to Improve Hypertension Management After Stroke or Transient Ischemic Attack (TIA) (TIMSII)

This study has been completed.
Sponsor:
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by (Responsible Party):
Gail MacKenzie, McMaster University
ClinicalTrials.gov Identifier:
NCT01038375
First received: December 22, 2009
Last updated: April 30, 2012
Last verified: April 2012
History of Changes
  Purpose

The purpose of this study is to determine the effectiveness of interventions to improve adherence to medication and healthier lifestyle choices on blood pressure over a 6 month period in a group of people at high risk for recurrent stroke events. The participants have already had a stroke or TIA, and have uncontrolled blood pressure, as well as problems with memory and problem-solving, or miss taking medications, or who do not believe in the effectiveness of their medications. Interventions focus on motivational interviewing, adherence counseling with memory cuing, and self-monitoring of blood pressure.


Condition Intervention
Blood Pressure
 Behavioral: lifestyle counseling, home blood pressure monitoring

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Tailored Interventions to Improve Hypertension Management After Stroke or TIA

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • blood pressure [ Time Frame: 6 months from baseline testing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • self-efficacy rating [ Time Frame: 6 months from baseline ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: March 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Adherence counseling Behavioral: lifestyle counseling, home blood pressure monitoring
monthly telephone counseling over 6 months for intervention group no health provider initiated contact for control group
Other Name: motivational interviewing
Usual care Behavioral: lifestyle counseling, home blood pressure monitoring
monthly telephone counseling over 6 months for intervention group no health provider initiated contact for control group
Other Name: motivational interviewing

Detailed Description:
  • randomized, controlled trial at 4 sites
  • measurement of blood pressure, missed pills, self-efficacy rating at baseline and 6 months
  • contacting family pharmacists to evaluate prescription renewal patterns at baseline and 6 months
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

clients recruited from Stroke Prevention Clinics in Ontario with diagnosis of Stroke or TIA, Hypertension, and cognitive deficits as indicated by MoCA score < 26, self-efficacy rating < 100%, and self-report of missed pills; English speaking; able to give informed consent; older than 18 years of age

Criteria

Inclusion Criteria:

  • diagnosis of stroke or TIA
  • hypertension
  • Montreal Cognitive Assessment score less than 26
  • self report of missed pills
  • self-efficacy rating less than 100%

Exclusion Criteria:

  • inability to give informed consent
  • 18 years of age or younger
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01038375

Locations
Canada, Ontario
Royal Victoria Hospital
Barrie, Ontario, Canada
Hamilton General Hospital, 237 Barton St East
Hamilton, Ontario, Canada, L8L 2X2
Lakeridge Health Centre
Oshawa, Ontario, Canada, L1G 2B9
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Heart and Stroke Foundation of Ontario
  More Information

No publications provided

Responsible Party: Gail MacKenzie, Clinical Nurse Specialist, Stroke Prevention Clinic, Hamilton Health Sciences, General Site, McMaster University
ClinicalTrials.gov Identifier: NCT01038375     History of Changes
Other Study ID Numbers: OSN0912-000106
Study First Received: December 22, 2009
Last Updated: April 30, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
hypertension
stroke
adherence

Additional relevant MeSH terms:
Ischemic Attack, Transient
Hypertension
Stroke
Brain Ischemia
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013