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Comparing Program Options for Latinos With Diabetes

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ClinicalTrials.gov Identifier: NCT03004664
Recruitment Status : Active, not recruiting
First Posted : December 29, 2016
Last Update Posted : November 4, 2020
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Janet M Page-Reeves, University of New Mexico

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

STUDY POPULATION:

Patients will be 240 individuals who consider themselves to be Latino and who are from low-income households. In addition, 240 patients will identify a corresponding social support to participate with them. Outcomes will be measured based on the 240 patient participants. Social support data will be measured as a covariate to understand patient outcomes.

PRIMARY OUTCOME:

Improved capacity for diabetes self-management measured as diabetes knowledge and patient activation or the ability to put that knowledge into action.

SECONDARY OUTCOME:

Successful diabetes self-management measured through reduced A1c, BMI and depression. Patient stress levels will also be measured using testing of hair samples to identify levels of cortisol as a biological marker for chronic stress.

METHODS:

Statistical calculations will be conducted to make sure that the things being compared are differences in program design and not differences in individual patient characteristics. This study will compare whether the programs improve diabetes health knowledge, ability to act, and A1c, BMI, depression and stress control, and determine which program is the best.


Condition or disease Intervention/treatment
Diabetes Mellitus Behavioral: Support Empowerment Model Behavioral: The Chronic Care Model

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Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Patient-Centered Framework to Test the Comparative Effectiveness of Culturally and Contextually Appropriate Program Options for Latinos With Diabetes From Low-Income Households
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : March 30, 2021

Group/Cohort Intervention/treatment
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 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.
Other Name: Diabetes Self-Management 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
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




Primary Outcome Measures :
  1. Patients will improve their capacity for diabetes self-management: Measured through change in Diabetes Knowledge [ Time Frame: (baseline to 3 months), (3 months to 6 months), (6 months to 12 months) ]
    Improvement in diabetes knowledge measured through change in scores on The Diabetes Knowledge Questionnaire [DKQ])

  2. Patients will improve their capacity for diabetes self-management: Measured through change in Patient Activation [ Time Frame: (baseline to 3 months), (3 months to 6 months), (6 months to 12 months) ]
    Improvement in patient ability to manage their own diabetes measured through changes in score on the Patient Activation Measure (PAM)


Secondary Outcome Measures :
  1. Patients will successfully self-manage their diabetes measured through change (reduction) in their blood glucose [ Time Frame: (baseline to 3 months), (3 months to 6 months), (6 months to 12 months) ]
    Reduction in their blood glucose as indicated by A1c 21

  2. Patients will successfully self-manage their diabetes measured through change (reduction) in Body Mass Index (BMI) [ Time Frame: (baseline to 3 months), (3 months to 6 months), (6 months to 12 months) ]
    Reduction in BMI

  3. Patients will successfully self-manage their diabetes as measured through change (reduction) in depression [ Time Frame: (baseline to 3 months), (3 months to 6 months), (6 months to 12 months) ]
    Reduction in depression measured through changes in depression index score in score on Patient Health Questionaire 9-Item set [PHQ-9])

  4. Patients will successfully self-manage their diabetes as measured though change (reduction) in chronic stress levels [ Time Frame: (baseline to 6 months), (6 months to 12 months) ]
    Improvement in chronic stress levels indicated through testing of hair sample for change (reduction) in circulating level of cortisol



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

INCLUSION CRITERIA:

Patient Participants:

  1. 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)
  2. Enter one of the two diabetes programs during the study
  3. Self-identify as "Latino"
  4. Can identify a social support or key member of their social network who will agree to participate with them
  5. Are not pregnant (participants who become pregnant during the study will be excluded)
  6. Have household income 250% of the Federal Poverty Level (FPL) or below.

Social support participants:

  1. Adults
  2. Individuals who are identified by the patient participants as their social support

Exclusion Criteria:

  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03004664


Locations
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United States, New Mexico
One Hope Centro de Vida Health Center
Albuquerque, New Mexico, United States, 87108
University of New Mexico Hospital
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Janet M Page-Reeves, Ph.D. University of New Mexico School of Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Janet M Page-Reeves, Research Assistant Professor, University of New Mexico
ClinicalTrials.gov Identifier: NCT03004664    
Other Study ID Numbers: 16-303
First Posted: December 29, 2016    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Janet M Page-Reeves, University of New Mexico:
Latinos
Low Income
Self Management
Education
Cultural Competence
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases