Clinical trial NCT01845857: A National Study of the Chronic Disease Self-Management Program
Official title: A National Study of the Chronic Disease Self-Management Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Chronic Disease
Keywords: Long term health problems
chronic disease
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2013-05-03
Enrollment: 1170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief 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?

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:

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?

Eligibility criteria: 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

Primary outcomes:
measure: Change in Health Status (symptoms, activities limitations)
timeFrame: Baseline to 6 months
measure: Change in Health Status (symptoms, activities limitations)
timeFrame: baseline to 12 months
Secondary outcomes:
measure: Change in Health behaviors (exercise, medical adherence)
timeFrame: baseline to 6 months
measure: Change in health related quality of life
timeFrame: baseline to 6 months
measure: Change in Metabolic control (HbA1c for type 2 diabetics)
timeFrame: baseline to 6 months
measure: Change in Health Care Utilization
timeFrame: baseline to 6 months
measure: Change in Health behaviors (exercise, medical adherence)
timeFrame: baseline to 12 months
measure: Change in health related quality of life
timeFrame: baseline to 12 months
measure: Change in Metabolic control (HbA1c for type 2 diabetics)
timeFrame: baseline to 12 months
measure: Change in Health Care Utilization
timeFrame: baseline to 12 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Kate R Lorig
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.