- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01845857
A National Study of the Chronic Disease Self-Management Program
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A national survey of participant outcomes is important for documenting how the CDSMP program is impacting people with chronic diseases and influencing health care outcomes. This study will help bridge the research to practice gap and further our knowledge about the outcomes of evidence?based programs that are widely disseminated.
Investigators hope to learn the answers to the following questions for English and Spanish-speaking populations:
- How does the CDSMP impact a person's general health?
- Does the CDSMP increase the use of healthful behaviors?
- Does the CDSMP impact health care utilization?
- What are the characteristics of those who benefit from the CDSMP?
- Can these benefits be maintained over 6 and 12 month periods?
- For people with type 2 diabetes, and hemoglobin A1c be impacted by the CDSMP?
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18 or over
- Has a chronic health condition
- Attending a Chronic Disease Self-Management Workshop at a designated host site in the United states
- Speaks English or Spanish
- For blood test portion of study: have type 2 diabetes
Exclusion Criteria:
- Do not meet inclusion criteria
Study Plan
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Chronic Disease Self-Management Workshop
Longitudinal study of participants who take the CDSMP workshop
|
6 week, small group self-management workshop
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Health Status (symptoms, activities limitations)
Time Frame: Baseline to 6 months
|
Baseline to 6 months
|
Change in Health Status (symptoms, activities limitations)
Time Frame: baseline to 12 months
|
baseline to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Health behaviors (exercise, medical adherence)
Time Frame: baseline to 6 months
|
baseline to 6 months
|
|
Change in health related quality of life
Time Frame: baseline to 6 months
|
baseline to 6 months
|
|
Change in Metabolic control (HbA1c for type 2 diabetics)
Time Frame: baseline to 6 months
|
baseline to 6 months
|
|
Change in Health Care Utilization
Time Frame: baseline to 6 months
|
MD, emergency, hospital times and total nights
|
baseline to 6 months
|
Change in Health behaviors (exercise, medical adherence)
Time Frame: baseline to 12 months
|
baseline to 12 months
|
|
Change in health related quality of life
Time Frame: baseline to 12 months
|
baseline to 12 months
|
|
Change in Metabolic control (HbA1c for type 2 diabetics)
Time Frame: baseline to 12 months
|
baseline to 12 months
|
|
Change in Health Care Utilization
Time Frame: baseline to 12 months
|
baseline to 12 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Lorig KR, Ritter P, Stewart AL, Sobel DS, Brown BW Jr, Bandura A, Gonzalez VM, Laurent DD, Holman HR. Chronic disease self-management program: 2-year health status and health care utilization outcomes. Med Care. 2001 Nov;39(11):1217-23. doi: 10.1097/00005650-200111000-00008.
- Lorig KR, Ritter PL, Gonzalez VM. Hispanic chronic disease self-management: a randomized community-based outcome trial. Nurs Res. 2003 Nov-Dec;52(6):361-9. doi: 10.1097/00006199-200311000-00003.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SU-07212010-6585
- 18933 IRB Protocol
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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