NCT01038375

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

May 1, 2012

Status Verified

April 1, 2012

Enrollment Period

1.6 years

First QC Date

December 22, 2009

Last Update Submit

April 30, 2012

Conditions

Keywords

hypertensionstrokeadherence

Outcome Measures

Primary Outcomes (1)

  • blood pressure

    6 months from baseline testing

Secondary Outcomes (1)

  • self-efficacy rating

    6 months from baseline

Study Arms (2)

Adherence counseling

Behavioral: lifestyle counseling, home blood pressure monitoring

Usual care

Behavioral: lifestyle counseling, home blood pressure monitoring

Interventions

monthly telephone counseling over 6 months for intervention group no health provider initiated contact for control group

Also known as: motivational interviewing
Adherence counselingUsual care

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • inability to give informed consent
  • years of age or younger

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Royal Victoria Hospital

Barrie, Ontario, Canada

Location

Hamilton General Hospital, 237 Barton St East

Hamilton, Ontario, L8L 2X2, Canada

Location

Lakeridge Health Centre

Oshawa, Ontario, L1G 2B9, Canada

Location

MeSH Terms

Conditions

HypertensionStroke

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Nurse Specialist, Stroke Prevention Clinic, Hamilton Health Sciences, General Site

Study Record Dates

First Submitted

December 22, 2009

First Posted

December 23, 2009

Study Start

March 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

May 1, 2012

Record last verified: 2012-04

Locations