- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00350922
A Clinical Trial of a Self-Management Education Program for People With Chronic Stable Angina
July 8, 2006 updated by: University of Toronto
A Psychoeducation Trial for People With Chronic Stable Angina
The purpose of this clinical trial was to determine the effectiveness of a supportive and educational self-management program for improving health-related quality of life (HRQOL), angina symptoms, and self-efficacy and resourcefulness to self-manage for chronic angina patients.
130 participants were enrolled in the trial for 3 months.
The program, entitled the Chronic Angina Self-Management Program, (CASMP) was found effective for improving HRQOL, angina symptoms, and self-efficacy to manage symptoms, compared to usual care.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
130
Phase
- Phase 1
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
-
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Ontario
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Toronto, Ontario, Canada, M5T 1P8
- University of Toronto
-
-
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
1 second and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Medical diagnosis of coronary artery disease CCS Class I-III Angina for at least 6 months Speak, read, understand English -
Exclusion Criteria:
MI/Bypass last 6 months CCS Class IV angina A major cognitive disorder -
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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SF36
|
Seattle Angina Questionnaire
|
Secondary Outcome Measures
Outcome Measure |
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Self-Efficacy Scale
|
Self-Control Schedule
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Judy H Watt-Watson, PhD, University of Toronto
- Principal Investigator: Michael H McGillion, PhD, University of Toronto
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
September 1, 2003
Study Completion
November 1, 2005
Study Registration Dates
First Submitted
July 8, 2006
First Submitted That Met QC Criteria
July 8, 2006
First Posted (Estimate)
July 11, 2006
Study Record Updates
Last Update Posted (Estimate)
July 11, 2006
Last Update Submitted That Met QC Criteria
July 8, 2006
Last Verified
November 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 452639
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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