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Spanish Diabetes Self-Management Program (SDSMP)

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ClinicalTrials.gov Identifier: NCT00496145
Recruitment Status : Completed
First Posted : July 4, 2007
Last Update Posted : April 19, 2016
Information provided by (Responsible Party):
Kate Lorig, Stanford University

Brief Summary:
Type II diabetes is a growing health concern for Latinos who not only have a higher incidence of the disease but also suffer great morbidity. At the same time due to poverty, language, low literacy and lack of continuity of care, this population is largely excluded from current diabetes education programs. To assist with this problem we propose to evaluate 1) a community-based, peer-led Spanish Diabetes Self-Management Program that is culturally appropriate and acceptable based on self-efficacy theory, and 2) the effects of long-term, self-tailored educational reinforcement offered by means of automated telephone disease management messages. Should this research be successful it will provide an evidenced based public health diabetes education model for use with Latino populations throughout the United States.

Condition or disease Intervention/treatment
Type 2 Diabetes Behavioral: Spanish Diabetes Self-Management Program

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 567 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Spanish Diabetes Self-Management Program
Study Start Date : August 2002
Primary Completion Date : September 2005
Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: treatment
Spanish Diabetes Self-Management Program
Behavioral: Spanish Diabetes Self-Management Program
small-group self management education program
No Intervention: control
usual-care control group

Primary Outcome Measures :
  1. Hemoglobin A1c, Health Distress, Symptoms of Hypoglycemia, Symptoms of Hyperglycemia [ Time Frame: 6 month and 18 month ]

Secondary Outcome Measures :
  1. Amount of exercise,self-efficacy, communication with physician,fatigue, activity limitation,physician visits [ Time Frame: 6-month and 18-month ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Diagnosed with type 2 diabetes
  • Speaks and understands Spanish language
  • Able to attend community based diabetes education workshops

Exclusion Criteria:

  • Pregnant
  • Undergoing active cancer treatment
  • Diagnosed with insulin dependant diabetes (type 1)
  • Pre or borderline diabetes
  • Prior or concurrent participation in other diabetes self-management program
  • Clinical diagnosis of Alzheimer's Disease
  • Mental health condition preventing group participation or cognitive ability

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): NCT00496145

United States, California
Stanford Patient Education Research Center
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
Principal Investigator: Kate R. Lorig, R.N., DrPH Stanford University Patient Education Research Center, Department of Medicine

Additional Information:
Lorig K, Gonzlez V. Community-based diabetes self-management education: definition and case study. Diabetes Spectrum 2000;13:234-238.
Holman H, Lorig K. Perceived self-efficacy in self-management of chronic disease In: Schwartz R, ed. Self-Efficacy: Thought Control of Action. Washington: Hemisphere Publishing; 1992:305-323.

Responsible Party: Kate Lorig, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT00496145     History of Changes
Other Study ID Numbers: 76357
NIH NR053250-04
First Posted: July 4, 2007    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016

Keywords provided by Kate Lorig, Stanford University:
self management
patient education
telephone reinforcement
Spanish Diabetes
Tomando Control de su Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases