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DiabetesNCT02779556

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

A study testing ACP Living with Diabetes Guide and ADA Living Well with Diabetes Workbook in people with Diabetes, run by University of Arkansas at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for
Diabetes
What is being tested?
ACP Living with Diabetes Guide and ADA Living Well with Diabetes Workbook
Could I receive a placebo?
No, everyone receives an active treatment
How many people
756 participants
Where
6 sitesUnited States
Study dates
7 Nov 2016to 12 Feb 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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%

Who cannot join

  • uncorrectable visual impairments
  • hearing impairments
  • cognitive impairments

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites
  • UAMS Family Medical Center Northwest

    Fayetteville, Arkansas, 72703

  • UAMS Family Medical Center Fort Smith

    Fort Smith, Arkansas, 72901

  • UAMS Family Medical Center Jonesboro

    Jonesboro, Arkansas, 72401

  • UAMS Family Medical Center Magnolia

    Magnolia, Arkansas, 71753

  • UAMS Family Medical Center Pine Bluff

    Pine Bluff, Arkansas, 71603

  • UAMS Family Medical Center Texarkana

    Texarkana, Arkansas, 71854

Other trials in United States

About this study

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.
Read the 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.
Conditions
Diabetes
Being tested
ACP Living with Diabetes Guide, ADA Living Well with Diabetes Workbook
Keywords
Health Literacy, Diabetes
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACP Living with Diabetes GuideOther

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

  • ADA Living Well with Diabetes WorkbookOther

    American Diabetes Association (ADA) Living Well with Diabetes Workbook

Study groups in NCT02779556
Study groupRoleWhat they receive
Enhanced Usual CareOtherADA Living Well with Diabetes Workbook, 15 minute in-person counseling, follow-up every 3 months
Receives: Other: ADA Living Well with Diabetes Workbook
InterventionOtherACP 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
Receives: Other: ACP Living with Diabetes Guide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hemoglobin A1C (HbA1C)

    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.

    Measured: Six months

  2. Hemoglobin A1C (HbA1C)

    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.

    Measured: Twelve months

Secondary outcomes (2)
  1. Diabetes Knowledge

    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.

    Measured: Three months

  2. Diabetes Knowledge (0-13)

    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.

    Measured: Six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2016 (estimated)
  2. Study start7 Nov 2016
  3. Primary completion12 Feb 2020
  4. Study completion12 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
756 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02779556
Sponsor's protocol ID
204290
Other IDs
1R01DK107572-01A1
Status last verified
Dec 2021
First submitted
4 May 2016
Last updated
15 Dec 2021
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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 request. Consulting with program officer to ensure data sharing compliance.

Questions about this trial

What is this clinical trial studying?

A study testing ACP Living with Diabetes Guide and ADA Living Well with Diabetes Workbook in people with Diabetes, run by University of Arkansas at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemoglobin A1C (HbA1C) (time frame: Six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2021.

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