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Health Literacy Intervention to Improve Diabetes Outcomes Among Rural Primary Care Patients

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ClinicalTrials.gov Identifier: NCT02779556
Recruitment Status : Recruiting
First Posted : May 20, 2016
Last Update Posted : June 14, 2018
Sponsor:
Collaborators:
Northwestern University
Louisiana State University Health Sciences Center Shreveport
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Arkansas

Brief Summary:

The researchers will conduct a patient-randomized, pragmatic clinical trial among 6 rural PCMHs in Arkansas, targeting individuals with uncontrolled type 2 diabetes.

The primary aims are to:

  1. test the effectiveness of the ACP diabetes health literacy intervention to improve a range of diabetes-related outcomes among rural patients;
  2. compared to usual care, evaluate whether the intervention reduces disparities by patient literacy level.

    The secondary aims are to:

  3. investigate whether a threshold or gradient effect exists between the amount of follow-up counseling (number of action plans) and intervention effectiveness;
  4. determine the fidelity of all intervention components, and explore any identified patient, provider (physician, nurse, health coach), and/or health system barriers to implementation; and
  5. assess the costs associated with implementing the intervention from a health system perspective.

Condition or disease Intervention/treatment Phase
Diabetes Other: ACP Living with Diabetes Guide Other: ADA Living Well with Diabetes Workbook Not Applicable

Detailed Description:

The investigators will test the effectiveness and fidelity of embedding the American College of Physicians (ACP) diabetes health literacy intervention among patient-centered medical homes throughout rural Arkansas. Proper diabetes self-care requires patients to have considerable knowledge, a range of skills, and to sustain multiple health behaviors. Self-management interventions are needed that have been designed for individuals with lower literacy skills, that can be readily implemented and sustained among rural clinics with limited resources that disproportionately care for patients with limited literacy. Researchers on the team developed an evidence-based, patient-centered, low literacy ACP intervention promoting diabetes self-care that includes:

  1. a diabetes guide that uses plain language and descriptive photographs to teach core diabetes concepts and empower patients to initiate behavior change;
  2. a brief counseling strategy to assist patients in developing short-term, explicit and attainable goals for behavior change (`action plans');
  3. a training module for physicians, nurses, and medical assistants that prepares providers to assume educator/counselor roles with the Diabetes Guide as a teaching tool;
  4. electronic tracking and monitoring tools for primary care practices.

While the intervention has previously been field tested and found to significantly improve patient knowledge, self-efficacy, and engagement in related health behaviors, it has not yet been comprehensively tested in practices, and its optimal implementation is not known. The investigators now have a unique opportunity to learn from prior evaluation, modify and disseminate an ACP health literacy intervention among patients with type 2 diabetes cared at rural clinics in Arkansas that are Patient-Centered Medical Homes (PCMH). These practices are embedding care coordination services that can be leveraged to improve chronic disease management. All are supervised by a new University of Arkansas for Medical Sciences (UAMS) Center for Health Literacy. The investigators' revised intervention will blend outsourced and clinic-based approaches and redeploy health coaches for counseling self-management mostly via phone, but also at the point-of-care. This is a feasible way to reach rural, vulnerable patients. The investigators will conduct a patient-randomized, pragmatic clinical trial among 6 rural PCMHs in Arkansas, targeting individuals with uncontrolled type 2 diabetes.

The primary aims are to:

  1. test the effectiveness of the ACP diabetes health literacy intervention to improve a range of diabetes-related outcomes among rural patients;
  2. compared to usual care, evaluate whether the intervention reduces disparities by patient literacy level.

    The secondary aims are to:

  3. investigate whether a threshold or gradient effect exists between the amount of follow-up counseling (number of action plans) and intervention effectiveness;
  4. determine the fidelity of all intervention components, and explore any identified patient, provider (physician, nurse, health coach), and/or health system barriers to implementation; and
  5. assess the costs associated with implementing the intervention from a health system perspective.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Health Literacy Intervention to Improve Diabetes Outcomes Among Rural Primary Care Patients
Actual Study Start Date : November 7, 2016
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Literacy

Arm Intervention/treatment
Enhanced Usual Care
ADA Living Well with Diabetes Workbook, 15 minute in-person counseling, follow-up every 3 months
Other: ADA Living Well with Diabetes Workbook
American Diabetes Association (ADA) Living Well with Diabetes Workbook

Intervention
ACP Living with Diabetes Guide, 15 minute in-person counseling , 15 minute follow-up counseling (3, 6, and 9 months), monthly phone calls after 3 months
Other: ACP Living with Diabetes Guide
American Colleges of Physicians (ACP) Living Well with Diabetes Guide




Primary Outcome Measures :
  1. Change in Hemoglobin A1C (HbA1C) [ Time Frame: Baseline to Six months ]
    HbA1C will be obtained from patients' electronic health records. Differences will be measured between the last measurement prior to baseline assessment and the last measured value closest to 6 month assessment.

  2. Change in Hemoglobin A1C (HbA1C) [ Time Frame: Baseline to Twelve months ]
    HbA1C will be obtained from patients' electronic health records. Differences will be measured between the last measurement prior to baseline assessment and the last measured value closest to 12 months post baseline.


Secondary Outcome Measures :
  1. Change in Diabetes Knowledge [ Time Frame: Baseline to Three months ]
    A self-reported Diabetes Knowledge Questionnaire that uses 13 multiple choice questions will be administered. Total scores range from 0-13 where higher scores demonstrate more knowledge.

  2. Change in Diabetes Knowledge [ Time Frame: Baseline to Six months ]
    A self-reported Diabetes Knowledge Questionnaire that uses 13 multiple choice questions will be administered. Total scores range from 0-13 where higher scores demonstrate more knowledge.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 21 years of age or older
  • English speaking
  • active patient at regional family medical center study site
  • confirmed diagnosis of type 2 diabetes as documented in the electronic health record
  • recent Hemoglobin A1c reading of >7.5% and less than or equal to 10%

Exclusion Criteria:

  • uncorrectable visual impairments
  • hearing impairments
  • cognitive impairments

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): NCT02779556


Contacts
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Contact: Jennifer Gan 501-296-1568 jgan@uams.edu
Contact: Kristie Hadden, PhD 501-686-2594 khadden@uams.edu

Locations
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United States, Arkansas
UAMS Family Medical Center Northwest Active, not recruiting
Fayetteville, Arkansas, United States, 72703
UAMS Family Medical Center Fort Smith Recruiting
Fort Smith, Arkansas, United States, 72901
Contact: Jennifer Gan    501-296-1568    jgan@uams.edu   
UAMS Family Medical Center Jonesboro Recruiting
Jonesboro, Arkansas, United States, 72401
Contact: Jennifer Gan    501-296-1568    jgan@uams.edu   
UAMS Family Medical Center Magnolia Recruiting
Magnolia, Arkansas, United States, 71753
Contact: Jennifer Gan    501-296-1568    jgan@uams.edu   
UAMS Family Medical Center Pine Bluff Recruiting
Pine Bluff, Arkansas, United States, 71603
Contact: Jennifer Gan    501-296-1568    jgan@uams.edu   
UAMS Family Medical Center Texarkana Recruiting
Texarkana, Arkansas, United States, 71854
Contact: Jennifer Gan    501-296-1568    jgan@uams.edu   
Sponsors and Collaborators
University of Arkansas
Northwestern University
Louisiana State University Health Sciences Center Shreveport
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Kristie Hadden, PhD University of Arkansas

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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT02779556     History of Changes
Other Study ID Numbers: 204290
1R01DK107572-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 20, 2016    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The investigators are committed to the open and timely dissemination of the research outcomes. Plans for sharing resources with the scientific community include presentations and publications in peer-reviewed journals. The final data set will be made available to NIH investigators upon completion of the study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Arkansas:
Health Literacy
Diabetes

Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases