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

NCT02779556 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 756

Last updated 2021-12-15

Study results available
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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.

Conditions

Interventions

OTHER

ACP Living with Diabetes Guide

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

OTHER

ADA Living Well with Diabetes Workbook

American Diabetes Association (ADA) Living Well with Diabetes Workbook

Sponsors & Collaborators

  • Northwestern University

    collaborator OTHER

  • Louisiana State University Health Sciences Center Shreveport

    collaborator OTHER

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Kristie Hadden, PhD · University of Arkansas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-07
Primary Completion
2020-02-12
Completion
2020-02-12

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02779556 on ClinicalTrials.gov