Blood PressureTIMSIINCT01038375
Tailored Interventions to Improve Hypertension Management After Stroke or Transient Ischemic Attack (TIA)
An observational study of Blood Pressure, run by Hamilton Health Sciences Corporation at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Blood Pressure
- What is being tested?
- lifestyle counseling, home blood pressure monitoring
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 56 participants
- Where
- 3 sitesCanada
- Study dates
- Mar 2010to Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- diagnosis of stroke or TIA
- hypertension
- Montreal Cognitive Assessment score less than 26
- self report of missed pills
- self-efficacy rating less than 100%
Who cannot join
- inability to give informed consent
- 18 years of age or younger
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Royal Victoria Hospital
Barrie, Ontario
Hamilton General Hospital, 237 Barton St East
Hamilton, Ontario, L8L 2X2
Lakeridge Health Centre
Oshawa, Ontario, L1G 2B9
About this study
Official title: 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.
Read the 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
- Conditions
- Blood Pressure
- Being tested
- lifestyle counseling, home blood pressure monitoring
- Keywords
- hypertension, stroke, adherence
- Medical subject headings
- Hypertension, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle counseling, home blood pressure monitoringBehavioural
Also called motivational interviewing
monthly telephone counseling over 6 months for intervention group no health provider initiated contact for control group
| Study group | Role | What they receive |
|---|---|---|
| Adherence counseling | Not described Receives: Behavioral: lifestyle counseling, home blood pressure monitoring | |
| Usual care | Not described Receives: Behavioral: lifestyle counseling, home blood pressure monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure
Measured: 6 months from baseline testing
Secondary outcomes (1)
self-efficacy rating
Measured: 6 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study startMar 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario
- Responsible party
- Principal investigator, Gail MacKenzie, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038375
- Sponsor's protocol ID
- OSN0912-000106
- Acronym
- TIMSII
- Status last verified
- Apr 2012
- First submitted
- 22 Dec 2009
- Last updated
- 1 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Interventions to Improve Hypertension Management After Stroke or TIA
- ClinicalTrials.gov ID
- NCT01038375
- Acronym / sponsor ID
- TIMSII / OSN0912-000106
- Conditions
- Blood Pressure
- Keywords
- hypertension, stroke, adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario
- Study start
- Mar 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 23 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adherence counseling | – | Behavioral: lifestyle counseling, home blood pressure monitoring |
| Usual care | – | Behavioral: lifestyle counseling, home blood pressure monitoring |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- diagnosis of stroke or TIA
- hypertension
- Montreal Cognitive Assessment score less than 26
- self report of missed pills
- self-efficacy rating less than 100%
Key exclusion criteria (2 listed)
- inability to give informed consent
- 18 years of age or younger
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lifestyle counseling, home blood pressure monitoringAlso: motivational interviewingmonthly telephone counseling over 6 months for intervention group no health provider initiated contact for control group | Behavioural | Adherence counseling, Usual care |
Primary outcome
blood pressure
Time frame: 6 months from baseline testing
1 secondary outcome
self-efficacy rating
Time frame: 6 months from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2012.
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Behavior
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure, run by Hamilton Health Sciences Corporation at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood pressure (time frame: 6 months from baseline testing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2012.