English Diabetes Self-Management Program
2 other identifiers
interventional
350
1 country
1
Brief Summary
We propose a diabetes self-management program evaluation and dissemination project with three components.
- 1.A six-month randomized trial to evaluate the effect of a community-based small group Diabetes Self Management Program (DSMP) on the health related quality of life, metabolic control and health care utilization of people with type 2 diabetes.
- 2.A long-term (12 month) longitudinal evaluation of the same program.
- 3.Two 5 day workshops to train others in California in how to lead and administer the program.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 22, 2008
CompletedFirst Posted
Study publicly available on registry
May 26, 2008
CompletedMay 26, 2008
May 1, 2008
May 22, 2008
May 23, 2008
Conditions
Outcome Measures
Primary Outcomes (5)
hemoglobin A1
symptoms of hypoglycemia
symptoms of hyperglycemia
self-monitoring of blood glucose
self-efficacy to manage diabetes
Secondary Outcomes (7)
fatigue
physical discomfort
activity limitations
health distress
self-rated health
- +2 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Individuals with prior diagnosis of type 2 Diabetes.
- Able to speak and comprehend English.
- Able to give and complete consent forms.
- Able to complete baseline questionnaire and 2-3 follow-up questionnaires either in writing or by telephone.
- Able to attend respective community meetings or allow study staff to collect the following metabolic test measures: provide 3 drops of blood for Hemoglobin A1c and cholesterol HDL test (administered by subject), blood pressure measure, height and weight measures.
- Able to attend the Peer-Led Community-Based Diabetes Self-Management Program workshops offered once a week for six weeks at a community site near subjects residence.
You may not qualify if:
- Individuals not diagnosed with type 2 diabetes.
- Individuals diagnosed with type 1 diabetes.
- Pregnant women, including those diagnosed with gestational diabetes.
- Individuals who have been in active treatment for cancer in the past yar.
- Individuals not able to speak or comprehend English.
- Individuals who are currently or have previously participated in a similar program or study.
- Individuals that are not able to give consent or complete consent forms, and other study related forms such as questionnaires.
- Individuals who are not able and willing to provide metabolic test data.
- Individuals not able to attend the 6-week community classes in the target counties in California.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford University School of Medicine
Stanford, California, 94305, United States
Related Publications (1)
Lorig K, Ritter PL, Villa FJ, Armas J. Community-based peer-led diabetes self-management: a randomized trial. Diabetes Educ. 2009 Jul-Aug;35(4):641-51. doi: 10.1177/0145721709335006. Epub 2009 Apr 30.
PMID: 19407333DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kate R Lorig
Stanford University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 22, 2008
First Posted
May 26, 2008
Study Start
April 1, 2007
Last Updated
May 26, 2008
Record last verified: 2008-05