Spanish Diabetes Self-Management Program

NCT00496145 | Completed DMC

• 2 other identifiers: 76357NIH NR053250-04
• Study Type: interventional
• Target: 567
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

diabetes; self management; patient education; telephone reinforcement; Spanish Diabetes; Tomando Control de su Diabetes

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c, Health Distress, Symptoms of Hypoglycemia, Symptoms of Hyperglycemia

  6 month and 18 month

Secondary Outcomes (1)

• Amount of exercise,self-efficacy, communication with physician,fatigue, activity limitation,physician visits

  6-month and 18-month

Study Arms (2)

treatment

EXPERIMENTAL

Spanish Diabetes Self-Management Program

Behavioral: Spanish Diabetes Self-Management Program

control

NO INTERVENTION

usual-care control group

Interventions

Spanish Diabetes Self-Management Program BEHAVIORAL

small-group self management education program

treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Patient Education Research Center

Palo Alto, California, 94304, United States

Location

Related Publications (9)

• Lorig K, Gonzlez V. Community-based diabetes self-management education: definition and case study. Diabetes Spectrum 2000;13:234-238.

  BACKGROUND

• Piette JD, Weinberger M, McPhee SJ, Mah CA, Kraemer FB, Crapo LM. Do automated calls with nurse follow-up improve self-care and glycemic control among vulnerable patients with diabetes? Am J Med. 2000 Jan;108(1):20-7. doi: 10.1016/s0002-9343(99)00298-3.

  PMID: 11059437 BACKGROUND

• 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.

  BACKGROUND

• Lorig K, Gonzalez VM, Ritter P. Community-based Spanish language arthritis education program: a randomized trial. Med Care. 1999 Sep;37(9):957-63. doi: 10.1097/00005650-199909000-00011.

  PMID: 10493473 BACKGROUND

• Lorig KR, Sobel DS, Stewart AL, Brown BW Jr, Bandura A, Ritter P, Gonzalez VM, Laurent DD, Holman HR. Evidence suggesting that a chronic disease self-management program can improve health status while reducing hospitalization: a randomized trial. Med Care. 1999 Jan;37(1):5-14. doi: 10.1097/00005650-199901000-00003.

  PMID: 10413387 BACKGROUND

• Piette JD, Weinberger M, McPhee SJ. The effect of automated calls with telephone nurse follow-up on patient-centered outcomes of diabetes care: a randomized, controlled trial. Med Care. 2000 Feb;38(2):218-30. doi: 10.1097/00005650-200002000-00011.

  PMID: 10659695 BACKGROUND

• Piette JD, Weinberger M, Kraemer FB, McPhee SJ. Impact of automated calls with nurse follow-up on diabetes treatment outcomes in a Department of Veterans Affairs Health Care System: a randomized controlled trial. Diabetes Care. 2001 Feb;24(2):202-8. doi: 10.2337/diacare.24.2.202.

  PMID: 11213866 BACKGROUND

• Ritter PL, Stewart AL, Kaymaz H, Sobel DS, Block DA, Lorig KR. Self-reports of health care utilization compared to provider records. J Clin Epidemiol. 2001 Feb;54(2):136-41. doi: 10.1016/s0895-4356(00)00261-4.

  PMID: 11166528 BACKGROUND

• Lorig KR, Ritter PL, Jacquez A. Outcomes of border health Spanish/English chronic disease self-management programs. Diabetes Educ. 2005 May-Jun;31(3):401-9. doi: 10.1177/0145721705276574.

  PMID: 15919640 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kate R. Lorig, R.N., DrPH

  Stanford University Patient Education Research Center, Department of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: July 3, 2007
• First Posted: July 4, 2007
• Study Start: August 1, 2002
• Primary Completion: September 1, 2005
• Study Completion: September 1, 2006
• Last Updated: April 19, 2016

Record last verified: 2016-04

Locations

US (1)