A National Study of the Chronic Disease Self-Management Program

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A National Study of the Chronic Disease Self-Management Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01845857
• Other study ID #: SU-07212010-6585
• Secondary ID: 18933 IRB Protoc
• Status: Completed
• Phase: N/A
• First received: August 9, 2010
• Last updated: April 30, 2013
• Start date: August 2010
• Est. completion date: April 2013

Study information

• Verified date: August 2010
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This survey will address important research, practice, and policy questions: How does Chronic Disease Self-Management Program (CDSMP) impact participants' general health, their health behaviors, and their need for health care utilization? Who benefits most from the CDSMP program? Are predicted gains maintained over a six and twelve month period? Can critical clinical changes be seen for those who are diabetic?

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:

1. How does the CDSMP impact a person's general health?

2. Does the CDSMP increase the use of healthful behaviors?

3. Does the CDSMP impact health care utilization?

4. What are the characteristics of those who benefit from the CDSMP?

5. Can these benefits be maintained over 6 and 12 month periods?

6. For people with type 2 diabetes, and hemoglobin A1c be impacted by the CDSMP?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1170
• Est. completion date: April 2013
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Chronic Disease
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Chronic Disease Self-Management Workshop
6 week, small group self-management workshop

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

Lorig KR, Ritter PL, González VM. Hispanic chronic disease self-management: a randomized community-based outcome trial. Nurs Res. 2003 Nov-Dec;52(6):361-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Health Status (symptoms, activities limitations)		Baseline to 6 months	No
Primary	Change in Health Status (symptoms, activities limitations)		baseline to 12 months	No
Secondary	Change in Health behaviors (exercise, medical adherence)		baseline to 6 months	No
Secondary	Change in health related quality of life		baseline to 6 months	No
Secondary	Change in Metabolic control (HbA1c for type 2 diabetics)		baseline to 6 months	No
Secondary	Change in Health Care Utilization	MD, emergency, hospital times and total nights	baseline to 6 months	No
Secondary	Change in Health behaviors (exercise, medical adherence)		baseline to 12 months	No
Secondary	Change in health related quality of life		baseline to 12 months	No
Secondary	Change in Metabolic control (HbA1c for type 2 diabetics)		baseline to 12 months	No
Secondary	Change in Health Care Utilization		baseline to 12 months	No

External Links

•   Summary of Chronic Disease Self-Management Program, including citations