Comparing Program Options for Latinos With Diabetes

NCT03004664 | Completed

• 1 other identifier: 16-303
• Study Type: observational
• Target: 452
• Locations: 1 country
• Sites: 2

Brief Summary

BACKGROUND AND SIGNIFICANCE: Diabetes is a national health problem, yet Latinos from low-income households are at greater risk. Although guidelines recommend that patients learn self-management strategies, many people are not able to do so effectively and cannot control their diabetes. Studies show that culturally competent self-management programming can help, but patients in preliminary research indicated that not all programs sufficiently respect patients' cultural values or account for their socio-economic limitations. STUDY AIMS: This project will compare two models for culturally competent diabetes self-management programming. The hypothesis is that the program model that best considers patient culture and accommodates patient socio-economic circumstances will have the best outcomes. COMPARATORS: 2 diabetes self-management program models used by many Latino patients from low-income households in Albuquerque, New Mexico

1. 1.The Diabetes Self-Management Support Empowerment Model
2. 2.The Chronic Care Model

Conditions

Diabetes Mellitus

Keywords

Latinos; Low Income; Self Management; Education; Cultural Competence

Outcome Measures

Primary Outcomes (2)

• Patients will improve their capacity for diabetes self-management: Measured through change in Diabetes Knowledge

  Improvement in diabetes knowledge measured through change in scores on The Diabetes Knowledge Questionnaire \[DKQ\])

  (baseline to 3 months), (3 months to 6 months), (6 months to 12 months)

• Patients will improve their capacity for diabetes self-management: Measured through change in Patient Activation

  Improvement in patient ability to manage their own diabetes measured through changes in score on the Patient Activation Measure (PAM)

  (baseline to 3 months), (3 months to 6 months), (6 months to 12 months)

Secondary Outcomes (4)

• Patients will successfully self-manage their diabetes measured through change (reduction) in their blood glucose

  (baseline to 3 months), (3 months to 6 months), (6 months to 12 months)

• Patients will successfully self-manage their diabetes measured through change (reduction) in Body Mass Index (BMI)

  (baseline to 3 months), (3 months to 6 months), (6 months to 12 months)

• Patients will successfully self-manage their diabetes as measured through change (reduction) in depression

  (baseline to 3 months), (3 months to 6 months), (6 months to 12 months)

• Patients will successfully self-manage their diabetes as measured though change (reduction) in chronic stress levels

  (baseline to 6 months), (6 months to 12 months)

Study Arms (2)

Support Empowerment Model

The Center for Diabetes Education at the University of New Mexico Hospital (CDE) uses the Diabetes Self-Management Support Empowerment Model (DSMS). The DSMS combines a series of clinically informed group didactic sessions that use a patient self-determination approach to empower patients to take control of their own diabetes health with follow-up supports to sustain self-management gains achieved during the sessions. Patients attend a six-week group instructional session with 9 hours of class plus an individual follow-up with a certified diabetes educator. The group sessions have discussion supported by didactic conversation "maps" where the facilitator guides but does not control the conversation based on session thematic goals.

Behavioral: Support Empowerment Model

The Chronic Care Model

One Hope Centro de Vida Diabetes Program is based on the Chronic Care Model (CCM). The CCM involves 6 synergistic domains: 1.) Improved access to care, 2.) Patient self-management support, 3.) Patient decision support, 4.) Care coordination, 5.) Integrated health information systems, and 6.) Access to community resources. To create a holistic care regime, the CCM focuses on addressing social determinants of health by meeting the medical, cultural, and linguistic needs of patients through integration of cultural norms and social relationships from the patient population into program design.

Behavioral: The Chronic Care Model

Interventions

Support Empowerment Model BEHAVIORAL

The DSMS combines a series of clinically informed group didactic sessions that use a patient self-determination approach to empower patients to take control of their own diabetes health with follow-up supports to sustain self-management gains achieved during the sessions.

Also known as: Diabetes Self-Management Support Empowerment Model

Support Empowerment Model

The Chronic Care Model BEHAVIORAL

the CCM focuses on addressing social determinants of health by meeting the medical, cultural, and linguistic needs of patients through integration of cultural norms and social relationships from the patient population into program design

The Chronic Care Model

Eligibility Criteria

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

Study Population

STUDY POPULATION: Patients will be identified through the diabetes programs at 2 sites: a total of 240 patient-caregiver pairs will be recruited: patients and a corresponding caregiver of each patient.

You may qualify if:

• Patient Participants:
• Adults (men and women) who have been identified by a provider as having pre-diabetes (A1c 5.7-6.4) or diabetes (A1c 6.5 or above)
• Enter one of the two diabetes programs during the study
• Self-identify as "Latino"
• Can identify a social support or key member of their social network who will agree to participate with them
• Are not pregnant (participants who become pregnant during the study will be excluded)
• Have household income 250% of the Federal Poverty Level (FPL) or below.
• Social support participants:
• Adults
• Individuals who are identified by the patient participants as their social support

You may not qualify if:

• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Prisoners
• Pregnant women
• Participants who become pregnant during the study will be excluded. At enrollment and before each data collection appointment, female patient participants will be screened to specifically exclude those who are pregnant. There is no risk to a pregnant woman or a fetus entailed in participation in this study because the study only involves data collection from individuals who have been instructed to participate in a diabetes self-management program by their provider. However, pregnant individuals will be excluded because pregnancy could impact outcomes in a way that will influence scientific analysis of diabetes self-management.

Sponsors & Collaborators

• University of New Mexico: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (2)

One Hope Centro de Vida Health Center

Albuquerque, New Mexico, 87108, United States

Location

University of New Mexico Hospital

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (1)

• Page-Reeves J, Regino L, Murray-Krezan C, Bleecker M, Erhardt E, Burge M, Bearer E, Mishra S. A comparative effectiveness study of two culturally competent models of diabetes self-management programming for Latinos from low-income households. BMC Endocr Disord. 2017 Jul 24;17(1):46. doi: 10.1186/s12902-017-0192-4.

  PMID: 28738902 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Janet M Page-Reeves, Ph.D.

  University of New Mexico School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: December 29, 2016
• Study Start: February 1, 2017
• Primary Completion: March 17, 2021
• Study Completion: January 30, 2023
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)