NCT00350922

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2003

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

September 1, 2003

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 11, 2006

Completed
Last Updated

July 11, 2006

Status Verified

November 1, 2005

First QC Date

July 8, 2006

Last Update Submit

July 8, 2006

Conditions

Chronic Stable Angina

Outcome Measures

Primary Outcomes (2)

  • SF36

  • Seattle Angina Questionnaire

Secondary Outcomes (2)

  • Self-Efficacy Scale

  • Self-Control Schedule

Interventions

PsychoeducationBEHAVIORAL

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Medical diagnosis of coronary artery disease CCS Class I-III Angina for at least 6 months Speak, read, understand English -

You may not qualify if:

  • MI/Bypass last 6 months CCS Class IV angina A major cognitive disorder -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Toronto

Toronto, Ontario, M5T 1P8, Canada

Location

MeSH Terms

Conditions

Angina, Stable

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Judy H Watt-Watson, PhD

    University of Toronto

    STUDY DIRECTOR

  • Michael H McGillion, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 8, 2006

First Posted

July 11, 2006

Study Start

September 1, 2003

Study Completion

November 1, 2005

Last Updated

July 11, 2006

Record last verified: 2005-11

Locations

CA(1)