Spanish Diabetes Self-Management Program (SDSMP)

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00496145
First received: July 3, 2007
Last updated: November 5, 2007
Last verified: November 2007
  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.

The aims of the study are to:

  1. Implement and evaluate in a 6-month randomized controlled trial an experimental community-based peer-led Spanish-language self-management program for patients with type 2 diabetes. Outcomes for evaluating the intervention's impact include health status (health-related quality-of-life and metabolic control) and health care utilization. Mediating outcomes are health behaviors and self-efficacy.
  2. Determine the effectiveness of automated telephone disease management messages as an adjunct to the Spanish Diabetes Self-Management Program in a randomized, multiple assessment, 18-month educational reinforcement trial.
  3. Conduct a cost-benefit analysis of the above interventions.
  4. Conduct an analysis to determine what baseline characteristics of participants best predict long-term, health-related quality of life and metabolic control as well as modeling the role of behaviors, self-efficacy, and health distress on quality of life, metabolic and health care utilization outcomes.

This proposed study will examine the following research questions:

Hypothesis 1. Subjects participating in the Spanish Diabetes Self-Management Program (SDSMP), when compared six months after baseline to randomized wait-list controls receiving usual care, will demonstrate:

  1. Improvements in health-related quality of life (fatigue, physical discomfort, the symptoms of hypoglycemia and hyperglycemia, activity limitations, health distress, and self-rated health).
  2. Improvements in metabolic measures of health status (body mass index, hemoglobin A1c, total cholesterol/HDL ratio and blood pressure).
  3. Changes in utilization of health services, specifically, increases in outpatient visits to physicians and nurses, increases in the percentage of subjects having received an eye examination in the past year, increases in the number of times a health professional has examined subject's feet, and decreases in emergency room visits, hospitalizations, and hospital days.
  4. Improvements in beneficial self-management behaviors (aerobic exercise, communication with physicians, diet, self-monitoring of blood glucose and self-examination of the feet).
  5. Increases in perceived self-efficacy to manage diabetes.

Hypothesis 2. The benefits of the Spanish Diabetes Self-Management Program (SDSMP) will be better maintained 18 months after baseline among participants who have received monthly-automated telephone disease management (ATDM) reinforcement compared with SDSMP participants who do not receive the supplemental guidance.


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

Resource links provided by NLM:


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 ]

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

Enrollment: 567
Study Start Date: August 2002
Study Completion Date: September 2006
  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.

ClinicalTrials.gov Identifier: NCT00496145     History of Changes
Other Study ID Numbers: 76357, NIH NR053250-04
Study First Received: July 3, 2007
Last Updated: November 5, 2007
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
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 29, 2014