A National Study of the Chronic Disease Self-Management Program

April 30, 2013 updated by: Kate Lorig, Stanford University
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?

Study Overview

Status

Completed

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:

  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?

Study Type

Interventional

Enrollment (Actual)

1170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Behavioral: Chronic Disease Self-Management 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

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

August 9, 2010

First Submitted That Met QC Criteria

April 30, 2013

First Posted (Estimate)

May 3, 2013

Study Record Updates

Last Update Posted (Estimate)

May 3, 2013

Last Update Submitted That Met QC Criteria

April 30, 2013

Last Verified

August 1, 2010

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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