<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03004664</url>
  </required_header>
  <id_info>
    <org_study_id>16-303</org_study_id>
    <nct_id>NCT03004664</nct_id>
  </id_info>
  <brief_title>Comparing Program Options for Latinos With Diabetes</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of New Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of New Mexico</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      BACKGROUND AND SIGNIFICANCE:&#xD;
&#xD;
      Diabetes is a national health problem, yet Latinos from low-income households are at greater&#xD;
      risk. Although guidelines recommend that patients learn self-management strategies, many&#xD;
      people are not able to do so effectively and cannot control their diabetes. Studies show that&#xD;
      culturally competent self-management programming can help, but patients in preliminary&#xD;
      research indicated that not all programs sufficiently respect patients' cultural values or&#xD;
      account for their socio-economic limitations.&#xD;
&#xD;
      STUDY AIMS:&#xD;
&#xD;
      This project will compare two models for culturally competent diabetes self-management&#xD;
      programming. The hypothesis is that the program model that best considers patient culture and&#xD;
      accommodates patient socio-economic circumstances will have the best outcomes.&#xD;
&#xD;
      COMPARATORS:&#xD;
&#xD;
      2 diabetes self-management program models used by many Latino patients from low-income&#xD;
      households in Albuquerque, New Mexico&#xD;
&#xD;
        1. The Diabetes Self-Management Support Empowerment Model&#xD;
&#xD;
        2. The Chronic Care Model&#xD;
&#xD;
      STUDY POPULATION:&#xD;
&#xD;
      Patients will be 240 individuals who consider themselves to be Latino and who are from&#xD;
      low-income households. In addition, 240 patients will identify a corresponding social support&#xD;
      to participate with them. Outcomes will be measured based on the 240 patient participants.&#xD;
      Social support data will be measured as a covariate to understand patient outcomes.&#xD;
&#xD;
      PRIMARY OUTCOME:&#xD;
&#xD;
      Improved capacity for diabetes self-management measured as diabetes knowledge and patient&#xD;
      activation or the ability to put that knowledge into action.&#xD;
&#xD;
      SECONDARY OUTCOME:&#xD;
&#xD;
      Successful diabetes self-management measured through reduced A1c, BMI and depression. Patient&#xD;
      stress levels will also be measured using testing of hair samples to identify levels of&#xD;
      cortisol as a biological marker for chronic stress.&#xD;
&#xD;
      METHODS:&#xD;
&#xD;
      Statistical calculations will be conducted to make sure that the things being compared are&#xD;
      differences in program design and not differences in individual patient characteristics. This&#xD;
      study will compare whether the programs improve diabetes health knowledge, ability to act,&#xD;
      and A1c, BMI, depression and stress control, and determine which program is the best.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND AND SIGNIFICANCE:&#xD;
&#xD;
      Diabetes is a national health priority but diabetes risk is extremely high for Latinos from&#xD;
      low-income households. Health guidelines recommend that individuals learn strategies to&#xD;
      self-management their diabetes, but getting people to adopt required lifestyle changes is&#xD;
      challenging and many people are not able to prevent their pre-diabetes from escalating or to&#xD;
      control their diabetes. Systematic reviews show that culturally competent self-management&#xD;
      programming can significantly improve diabetes outcomes, and different models for culturally&#xD;
      competent programming have been developed.&#xD;
&#xD;
      STUDY AIMS:&#xD;
&#xD;
      The goal of this study is to compare the effectiveness of 2 distinct evidence-based models&#xD;
      for culturally competent diabetes health promotion. The hypothesis is that the program model&#xD;
      that interfaces most synergistically with patient's culture and everyday life circumstances&#xD;
      will have the best diabetes health outcomes.&#xD;
&#xD;
      Aim 1: Characterize the ways that three culturally competent diabetes self-management&#xD;
      programs interface with patient culture and socioeconomic context&#xD;
&#xD;
      Aim 2: Measure and compare improvement in patient capacity for diabetes self-management.&#xD;
&#xD;
      Aim 3: Measure and compare patient success at self-management Study Description&#xD;
&#xD;
      OVERALL STUDY DESIGN:&#xD;
&#xD;
      This study follows NIH standards for mixed-method research by integrating data from&#xD;
      quantitative and qualitative components of the study in an iterative fashion. The sample size&#xD;
      and power estimates are based on realistic evaluation of effect size. Data collection will&#xD;
      involve programmatic assessments, interviews, focus groups, surveys, and testing for A1c,&#xD;
      BMI, and stress. The research team has the expertise and experience in patient-engaged&#xD;
      research necessary to conduct the proposed study and the investigators have an institutional&#xD;
      infrastructure that supports the academic and community partnerships necessary for this&#xD;
      study.&#xD;
&#xD;
      MAIN COMPONENTS OF THE INTERVENTION AND COMPARATORS:&#xD;
&#xD;
      This study compares 2 diabetes self-management programs that serve a large Latino patient&#xD;
      population from low-income households in Albuquerque, New Mexico&#xD;
&#xD;
        1. The Diabetes Self-Management Support Empowerment Model&#xD;
&#xD;
        2. The Chronic Care Model&#xD;
&#xD;
      PRIMARY &amp; SECONDARY OUTCOMES:&#xD;
&#xD;
      PRIMARY: Improved capacity for diabetes self-management measured through improvements in&#xD;
      diabetes knowledge and diabetes-related patient activation.&#xD;
&#xD;
      SECONDARY: Successful diabetes self-management.&#xD;
&#xD;
      ANALYTIC METHODS:&#xD;
&#xD;
      Descriptive statistics will be calculated to summarize patient characteristics. Means and&#xD;
      standard deviations or medians and quartiles will be calculated for continuous variables and&#xD;
      will be compared across site by ANOVA or Kruskal-Wallis test, depending on the distribution&#xD;
      of the data. Frequencies and percentages will be calculated for categorical variables and&#xD;
      will be compared with the chi-square test or Fisher's exact test, as appropriate. Significant&#xD;
      differences will be noted and to adjust for possible confounding, those variables will be&#xD;
      considered for inclusion as covariates in the analyses for the primary and secondary outcomes&#xD;
      in addition to other clinically meaningful variables and their interactions. It is expected&#xD;
      that patient characteristics to be similar across the two treatment sites; however, to&#xD;
      control for potential differences in the populations, the investigators will adjust for&#xD;
      potential confounding covariates by using propensity scores to stratify subjects into groups&#xD;
      based on the probability that they attended a particular treatment site given particular&#xD;
      demographic characteristics including sex, age, primary language, level of education,&#xD;
      nativity, and type of insurance. Patients will be grouped by quintile of propensity score for&#xD;
      a total of five strata and each will be analyzed for the primary and secondary outcomes&#xD;
      independently. Analyses will be performed in standard statistical software. Propensity score&#xD;
      matching allows for causal inference in our non-experimental settings by selecting similar&#xD;
      subsets of comparison units between treatment groups across a high-dimensional set of&#xD;
      pretreatment characteristics. For qualitative data, the investigators will conduct a&#xD;
      rigorous, disciplined, empirical analysis based on plausibility, credibility and relevance.&#xD;
      The investigators will conduct a theory-driven qualitative content analysis, reading through&#xD;
      transcripts to identify conceptual categories and patterns related to specified domains of&#xD;
      inquiry, creating a qualitative codebook, and developing conceptual summaries for each&#xD;
      transcript. Following review and summary, the investigators will code transcripts for&#xD;
      systematic themes and subthemes and explore interconnections between theme categories and&#xD;
      develop a holistic interpretation of the data (&quot;constant comparison&quot;).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">January 30, 2023</completion_date>
  <primary_completion_date type="Actual">March 17, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Patients will improve their capacity for diabetes self-management: Measured through change in Diabetes Knowledge</measure>
    <time_frame>(baseline to 3 months), (3 months to 6 months), (6 months to 12 months)</time_frame>
    <description>Improvement in diabetes knowledge measured through change in scores on The Diabetes Knowledge Questionnaire [DKQ])</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patients will improve their capacity for diabetes self-management: Measured through change in Patient Activation</measure>
    <time_frame>(baseline to 3 months), (3 months to 6 months), (6 months to 12 months)</time_frame>
    <description>Improvement in patient ability to manage their own diabetes measured through changes in score on the Patient Activation Measure (PAM)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patients will successfully self-manage their diabetes measured through change (reduction) in their blood glucose</measure>
    <time_frame>(baseline to 3 months), (3 months to 6 months), (6 months to 12 months)</time_frame>
    <description>Reduction in their blood glucose as indicated by A1c 21</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients will successfully self-manage their diabetes measured through change (reduction) in Body Mass Index (BMI)</measure>
    <time_frame>(baseline to 3 months), (3 months to 6 months), (6 months to 12 months)</time_frame>
    <description>Reduction in BMI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients will successfully self-manage their diabetes as measured through change (reduction) in depression</measure>
    <time_frame>(baseline to 3 months), (3 months to 6 months), (6 months to 12 months)</time_frame>
    <description>Reduction in depression measured through changes in depression index score in score on Patient Health Questionaire 9-Item set [PHQ-9])</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients will successfully self-manage their diabetes as measured though change (reduction) in chronic stress levels</measure>
    <time_frame>(baseline to 6 months), (6 months to 12 months)</time_frame>
    <description>Improvement in chronic stress levels indicated through testing of hair sample for change (reduction) in circulating level of cortisol</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">226</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Support Empowerment Model</arm_group_label>
    <description>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 &quot;maps&quot; where the facilitator guides but does not control the conversation based on session thematic goals.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>The Chronic Care Model</arm_group_label>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Support Empowerment Model</intervention_name>
    <description>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.</description>
    <arm_group_label>Support Empowerment Model</arm_group_label>
    <other_name>Diabetes Self-Management Support Empowerment Model</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>The Chronic Care Model</intervention_name>
    <description>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</description>
    <arm_group_label>The Chronic Care Model</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        STUDY POPULATION:&#xD;
&#xD;
        Patients will be identified through the diabetes programs at 2 sites: a total of 240&#xD;
        patient-caregiver pairs will be recruited: patients and a corresponding caregiver of each&#xD;
        patient.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        INCLUSION CRITERIA:&#xD;
&#xD;
        Patient Participants:&#xD;
&#xD;
          1. Adults (men and women) who have been identified by a provider as having pre-diabetes&#xD;
             (A1c 5.7-6.4) or diabetes (A1c 6.5 or above)&#xD;
&#xD;
          2. Enter one of the two diabetes programs during the study&#xD;
&#xD;
          3. Self-identify as &quot;Latino&quot;&#xD;
&#xD;
          4. Can identify a social support or key member of their social network who will agree to&#xD;
             participate with them&#xD;
&#xD;
          5. Are not pregnant (participants who become pregnant during the study will be excluded)&#xD;
&#xD;
          6. Have household income 250% of the Federal Poverty Level (FPL) or below.&#xD;
&#xD;
        Social support participants:&#xD;
&#xD;
          1. Adults&#xD;
&#xD;
          2. Individuals who are identified by the patient participants as their social support&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Adults unable to consent&#xD;
&#xD;
          -  Individuals who are not yet adults (infants, children, teenagers)&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
        Participants who become pregnant during the study will be excluded. At enrollment and&#xD;
        before each data collection appointment, female patient participants will be screened to&#xD;
        specifically exclude those who are pregnant. There is no risk to a pregnant woman or a&#xD;
        fetus entailed in participation in this study because the study only involves data&#xD;
        collection from individuals who have been instructed to participate in a diabetes&#xD;
        self-management program by their provider. However, pregnant individuals will be excluded&#xD;
        because pregnancy could impact outcomes in a way that will influence scientific analysis of&#xD;
        diabetes self-management.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janet M Page-Reeves, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of New Mexico School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>One Hope Centro de Vida Health Center</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of New Mexico Hospital</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>January 30, 2023</last_update_submitted>
  <last_update_submitted_qc>January 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of New Mexico</investigator_affiliation>
    <investigator_full_name>Janet M Page-Reeves</investigator_full_name>
    <investigator_title>Research Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Latinos</keyword>
  <keyword>Low Income</keyword>
  <keyword>Self Management</keyword>
  <keyword>Education</keyword>
  <keyword>Cultural Competence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03004664
org study id: 16-303
nct id: NCT03004664
lead sponsor: 
collaborator: 
has dmc: No
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.
BACKGROUND AND SIGNIFICANCE:

      Diabetes is a national health priority but diabetes risk is extremely high for Latinos from
      low-income households. Health guidelines recommend that individuals learn strategies to
      self-management their diabetes, but getting people to adopt required lifestyle changes is
      challenging and many people are not able to prevent their pre-diabetes from escalating or to
      control their diabetes. Systematic reviews show that culturally competent self-management
      programming can significantly improve diabetes outcomes, and different models for culturally
      competent programming have been developed.

      STUDY AIMS:

      The goal of this study is to compare the effectiveness of 2 distinct evidence-based models
      for culturally competent diabetes health promotion. The hypothesis is that the program model
      that interfaces most synergistically with patient's culture and everyday life circumstances
      will have the best diabetes health outcomes.

      Aim 1: Characterize the ways that three culturally competent diabetes self-management
      programs interface with patient culture and socioeconomic context

      Aim 2: Measure and compare improvement in patient capacity for diabetes self-management.

      Aim 3: Measure and compare patient success at self-management Study Description

      OVERALL STUDY DESIGN:

      This study follows NIH standards for mixed-method research by integrating data from
      quantitative and qualitative components of the study in an iterative fashion. The sample size
      and power estimates are based on realistic evaluation of effect size. Data collection will
      involve programmatic assessments, interviews, focus groups, surveys, and testing for A1c,
      BMI, and stress. The research team has the expertise and experience in patient-engaged
      research necessary to conduct the proposed study and the investigators have an institutional
      infrastructure that supports the academic and community partnerships necessary for this
      study.

      MAIN COMPONENTS OF THE INTERVENTION AND COMPARATORS:

      This study compares 2 diabetes self-management programs that serve a large Latino patient
      population from low-income households in Albuquerque, New Mexico

        1. The Diabetes Self-Management Support Empowerment Model

        2. The Chronic Care Model

      PRIMARY & SECONDARY OUTCOMES:

      PRIMARY: Improved capacity for diabetes self-management measured through improvements in
      diabetes knowledge and diabetes-related patient activation.

      SECONDARY: Successful diabetes self-management.

      ANALYTIC METHODS:

      Descriptive statistics will be calculated to summarize patient characteristics. Means and
      standard deviations or medians and quartiles will be calculated for continuous variables and
      will be compared across site by ANOVA or Kruskal-Wallis test, depending on the distribution
      of the data. Frequencies and percentages will be calculated for categorical variables and
      will be compared with the chi-square test or Fisher's exact test, as appropriate. Significant
      differences will be noted and to adjust for possible confounding, those variables will be
      considered for inclusion as covariates in the analyses for the primary and secondary outcomes
      in addition to other clinically meaningful variables and their interactions. It is expected
      that patient characteristics to be similar across the two treatment sites; however, to
      control for potential differences in the populations, the investigators will adjust for
      potential confounding covariates by using propensity scores to stratify subjects into groups
      based on the probability that they attended a particular treatment site given particular
      demographic characteristics including sex, age, primary language, level of education,
      nativity, and type of insurance. Patients will be grouped by quintile of propensity score for
      a total of five strata and each will be analyzed for the primary and secondary outcomes
      independently. Analyses will be performed in standard statistical software. Propensity score
      matching allows for causal inference in our non-experimental settings by selecting similar
      subsets of comparison units between treatment groups across a high-dimensional set of
      pretreatment characteristics. For qualitative data, the investigators will conduct a
      rigorous, disciplined, empirical analysis based on plausibility, credibility and relevance.
      The investigators will conduct a theory-driven qualitative content analysis, reading through
      transcripts to identify conceptual categories and patterns related to specified domains of
      inquiry, creating a qualitative codebook, and developing conceptual summaries for each
      transcript. Following review and summary, the investigators will code transcripts for
      systematic themes and subthemes and explore interconnections between theme categories and
      develop a holistic interpretation of the data ("constant comparison").
observational model: Cohort
time perspective: Prospective
measure: 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)
description: Improvement in diabetes knowledge measured through change in scores on The Diabetes Knowledge Questionnaire [DKQ])
measure: 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)
description: Improvement in patient ability to manage their own diabetes measured through changes in score on the Patient Activation Measure (PAM)
measure: 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)
description: Reduction in their blood glucose as indicated by A1c 21
measure: 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)
description: Reduction in BMI
measure: 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)
description: Reduction in depression measured through changes in depression index score in score on Patient Health Questionaire 9-Item set [PHQ-9])
measure: 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)
description: Improvement in chronic stress levels indicated through testing of hair sample for change (reduction) in circulating level of cortisol
arm group label: Support Empowerment Model
description: 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.
arm group label: The Chronic Care Model
description: 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.
intervention type: Behavioral
intervention name: Support Empowerment Model
description: 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.
arm group label: Support Empowerment Model
other name: Diabetes Self-Management Support Empowerment Model
intervention type: Behavioral
intervention name: The Chronic Care Model
description: 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
arm group label: The Chronic Care Model
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Janet M Page-Reeves, Ph.D.
role: Principal Investigator
affiliation: University of New Mexico School of Medicine
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of New Mexico
investigator full name: Janet M Page-Reeves
investigator title: Research Assistant Professor
mesh term: Diabetes Mellitus
sharing ipd: No