Spanish Diabetes Self-Management Program (SDSMP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kate Lorig, Stanford University
ClinicalTrials.gov Identifier:
NCT00496145
First received: July 3, 2007
Last updated: April 18, 2016
Last verified: April 2016
  Purpose
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 Intervention
Type 2 Diabetes
Behavioral: Spanish Diabetes Self-Management Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Spanish Diabetes Self-Management Program

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Hemoglobin A1c, Health Distress, Symptoms of Hypoglycemia, Symptoms of Hyperglycemia [ Time Frame: 6 month and 18 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Amount of exercise,self-efficacy, communication with physician,fatigue, activity limitation,physician visits [ Time Frame: 6-month and 18-month ] [ Designated as safety issue: No ]

Enrollment: 567
Study Start Date: August 2002
Study Completion Date: September 2006
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496145

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

Additional Information:
Publications:
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 
Study First Received: July 3, 2007
Last Updated: April 18, 2016
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 26, 2016