Spanish Diabetes Self-Management Program (SDSMP)
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:
- 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.
- 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.
- Conduct a cost-benefit analysis of the above interventions.
- 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:
- Improvements in health-related quality of life (fatigue, physical discomfort, the symptoms of hypoglycemia and hyperglycemia, activity limitations, health distress, and self-rated health).
- Improvements in metabolic measures of health status (body mass index, hemoglobin A1c, total cholesterol/HDL ratio and blood pressure).
- 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.
- Improvements in beneficial self-management behaviors (aerobic exercise, communication with physicians, diet, self-monitoring of blood glucose and self-examination of the feet).
- 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.
|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|
- Hemoglobin A1c, Health Distress, Symptoms of Hypoglycemia, Symptoms of Hyperglycemia [ Time Frame: 6 month and 18 month ]
- Amount of exercise,self-efficacy, communication with physician,fatigue, activity limitation,physician visits [ Time Frame: 6-month and 18-month ]
|Study Start Date:||August 2002|
|Study Completion Date:||September 2006|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00496145
|United States, California|
|Stanford Patient Education Research Center|
|Palo Alto, California, United States, 94304|
|Principal Investigator:||Kate R. Lorig, R.N., DrPH||Stanford University Patient Education Research Center, Department of Medicine|