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Trial record 91 of 243823 for:    Diseases

A National Study of the Chronic Disease Self-Management Program

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ClinicalTrials.gov Identifier: NCT01845857
Recruitment Status : Completed
First Posted : May 3, 2013
Last Update Posted : May 3, 2013
Sponsor:
Information provided by (Responsible Party):
Kate Lorig, Stanford University

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?

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Chronic Disease Behavioral: Chronic Disease Self-Management Workshop Not Applicable

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?

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1170 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A National Study of the Chronic Disease Self-Management Program
Study Start Date : August 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change in Health Status (symptoms, activities limitations) [ Time Frame: Baseline to 6 months ]
  2. Change in Health Status (symptoms, activities limitations) [ Time Frame: baseline to 12 months ]

Secondary Outcome Measures :
  1. Change in Health behaviors (exercise, medical adherence) [ Time Frame: baseline to 6 months ]
  2. Change in health related quality of life [ Time Frame: baseline to 6 months ]
  3. Change in Metabolic control (HbA1c for type 2 diabetics) [ Time Frame: baseline to 6 months ]
  4. Change in Health Care Utilization [ Time Frame: baseline to 6 months ]
    MD, emergency, hospital times and total nights

  5. Change in Health behaviors (exercise, medical adherence) [ Time Frame: baseline to 12 months ]
  6. Change in health related quality of life [ Time Frame: baseline to 12 months ]
  7. Change in Metabolic control (HbA1c for type 2 diabetics) [ Time Frame: baseline to 12 months ]
  8. Change in Health Care Utilization [ Time Frame: baseline to 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01845857


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Kate R Lorig Stanford University

Additional Information:
Publications:
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Responsible Party: Kate Lorig, professor emertius, Stanford University
ClinicalTrials.gov Identifier: NCT01845857     History of Changes
Other Study ID Numbers: SU-07212010-6585
18933 IRB Protocol
First Posted: May 3, 2013    Key Record Dates
Last Update Posted: May 3, 2013
Last Verified: August 2010

Keywords provided by Kate Lorig, Stanford University:
Long term health problems
chronic disease

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Chronic Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Disease Attributes
Pathologic Processes