Chronic Stable AnginaPhase 1NCT00350922
A Clinical Trial of a Self-Management Education Program for People With Chronic Stable Angina
A Phase 1 study testing Psychoeducation in people with Chronic Stable Angina, run by University of Toronto at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Chronic Stable Angina
- What is being tested?
- Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 130 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2003to Nov 2005
- Phase
- Phase 1
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Medical diagnosis of coronary artery disease CCS Class I-III Angina for at least 6 months Speak, read, understand English -
Who cannot join
- MI/Bypass last 6 months CCS Class IV angina A major cognitive disorder -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Stable Angina
- Being tested
- Psychoeducation
- Medical subject headings
- Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychoeducationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
SF36
Seattle Angina Questionnaire
Secondary outcomes (2)
Self-Efficacy Scale
Self-Control Schedule
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2006 (estimated)
- Study startSep 2003
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Stable AnginaStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Investigators
- Judy H Watt-Watson, PhD, Study director, University of TorontoMichael H McGillion, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00350922
- Sponsor's protocol ID
- 452639
- Status last verified
- Nov 2005
- First submitted
- 8 Jul 2006
- Last updated
- 11 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Psychoeducation Trial for People With Chronic Stable Angina
- ClinicalTrials.gov ID
- NCT00350922
- Acronym / sponsor ID
- 452639
- Conditions
- Chronic Stable Angina
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- Sep 2003
- Study completion
- Nov 2005
- First posted
- 11 Jul 2006 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Medical diagnosis of coronary artery disease CCS Class I-III Angina for at least 6 months Speak, read, understand English -
Key exclusion criteria (1 listed)
- MI/Bypass last 6 months CCS Class IV angina A major cognitive disorder -
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 |
|---|---|---|
| Psychoeducation | Behavioural | – |
Primary outcome
SF36
Seattle Angina Questionnaire
2 secondary outcomes
Self-Efficacy Scale
Self-Control Schedule
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2006.
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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.
Judy H Watt-Watson, PhD study director
University of Toronto
Michael H McGillion, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Psychoeducation in people with Chronic Stable Angina, run by University of Toronto at 1 site 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
SF36. The study lists 2 primary outcomes in all. 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 11 Jul 2006.