A Clinical Trial of a Self-Management Education Program f... | NCT00350922

Studies
A Clinical Trial of a Self-Management Education Program for People With Chronic Stable Angina

NCT00350922

Sponsor

University of Toronto

Status

Unknown status

Last Update Posted

Jul 11, 2006Estimated

Enrollment

130

Phase

Phase 1

Conditions

Chronic Stable Angina

Interventions

Psychoeducation

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2003

Primary Completion Date

Not provided

Completion Date

Nov 2005

First Submitted Date

Jul 8, 2006

First Submission Date that Met QC Criteria

Jul 8, 2006

First Posted Date

Jul 11, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2006

Last Update Posted Date

Jul 11, 2006Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130

Name	Type	Description	Arm Group Labels	Other Names
Psychoeducation	Behavioral

Eligibility Module

Eligibility Criteria

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 -

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Judy H Watt-Watson, PhD	University of Toronto	Study Director
Michael H McGillion, PhD	University of Toronto	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Toronto		Toronto	Ontario	M5T 1P8	Canada

Condition Browse Module

MeSH Terms

ID	Term
D060050	Angina, Stable

Ancestor Terms

ID	Term
D000787	Angina Pectoris
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
SF36
Seattle Angina Questionnaire

Measure	Description	Time Frame
Self-Efficacy Scale
Self-Control Schedule