CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 756 enrolled
Drug / intervention
ACP Living with Diabetes Guide +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02779556
NCT02779556N/ACompleted

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

University of Arkansas·interventional·Posted May 20, 2016·Updated Dec 15, 2021

In Brief

A clinical study evaluating ACP Living with Diabetes Guide and ADA Living Well with Diabetes Workbook for Diabetes. Completed, enrolled 756 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMay 20, 2016
Enrollment StartNov 7, 2016
Primary CompletionFeb 12, 2020
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 10.1 years ago

Interventions

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