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Completed

NCT Number: NCT02779556

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

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UAMS Family Medical Center Northwest, Fayetteville, Arkansas, United States

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About this study

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:

  • a diabetes guide that uses plain language and descriptive photographs to teach core diabetes concepts and empower patients to initiate behavior change;
  • a brief counseling strategy to assist patients in developing short-term, explicit and attainable goals for behavior change ('action plans');
  • 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;
  • 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:

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

The secondary aims are to:

  • investigate whether a threshold or gradient effect exists between the amount of follow-up counseling (number of action plans) and intervention effectiveness;
  • 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
  • assess the costs associated with implementing the intervention from a health system perspective.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACP Living with Diabetes Guide

Other

American Colleges of Physicians (ACP) Living Well with Diabetes Guide

ADA Living Well with Diabetes Workbook

Other

American Diabetes Association (ADA) Living Well with Diabetes Workbook

Primary outcomes

  1. Hemoglobin A1C (HbA1C)

    Time frame: Six months

    HbA1C will be obtained from patients' electronic health records, defined as the value closest to 6 months post baseline. The hemoglobin A1c (HbA1c) value ranges from approximately 4 to 14% where higher HbA1c value means worse outcome.

  2. Hemoglobin A1C (HbA1C)

    Time frame: Twelve months

    HbA1C will be obtained from patients' electronic health records, defined as the value closest to 12 months post baseline. The hemoglobin A1c (HbA1c) value ranges from approximately 4 to 14% where higher HbA1c value means worse outcome.

Secondary outcomes

  1. Diabetes Knowledge

    Time frame: 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. Diabetes Knowledge (0-13)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Collaborators

  • Louisiana State University Health Sciences Center Shreveport
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Northwestern University

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
May 20, 2016
Registry last updated
Dec 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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