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

April 30, 2012 updated by: Gail MacKenzie, Hamilton Health Sciences Corporation

Tailored Interventions to Improve Hypertension Management After Stroke or TIA

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Barrie, Ontario, Canada
        • Royal Victoria Hospital
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton General Hospital, 237 Barton St East
      • Oshawa, Ontario, Canada, L1G 2B9
        • Lakeridge Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • 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 Names:
  • motivational interviewing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
blood pressure
Time Frame: 6 months from baseline testing
6 months from baseline testing

Secondary Outcome Measures

Outcome Measure
Time Frame
self-efficacy rating
Time Frame: 6 months from baseline
6 months from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Health Sciences Corporation

Collaborators

Heart and Stroke Foundation of Ontario

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

December 22, 2009

First Submitted That Met QC Criteria

December 22, 2009

First Posted (Estimate)

December 23, 2009

Study Record Updates

Last Update Posted (Estimate)

May 1, 2012

Last Update Submitted That Met QC Criteria

April 30, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSN0912-000106

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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