N/A
N=756
Health Literacy Intervention to Improve Diabetes Outcomes Among Rural Primary Care Patients
Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT02779556 ↗Enrolled (actual)
756
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcome: Primary: Hemoglobin A1C (HbA1C) — 8.4; 8.3 Percentage of glycated hemoglobin
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ACP Living with Diabetes Guide (Other); ADA Living Well with Diabetes Workbook (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Arkansas
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin A1C (HbA1C) |
8.5; 8.4 | — |
| PRIMARY Hemoglobin A1C (HbA1C) |
8.5; 8.4 | — |
| SECONDARY Diabetes Knowledge |
9.2; 9.3 | — |
| SECONDARY Diabetes Knowledge (0-13) |
9.5; 9.7 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02779556). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.