Health Literacy Intervention to Improve Diabetes Outcomes Among Rural Primary Care Patients
2 other identifiers
interventional
756
1 country
6
Brief 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.
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes
Started Nov 2016
Typical duration for not_applicable diabetes
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2016
CompletedFirst Posted
Study publicly available on registry
May 20, 2016
CompletedStudy Start
First participant enrolled
November 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 12, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 12, 2020
CompletedResults Posted
Study results publicly available
December 15, 2021
CompletedDecember 15, 2021
December 1, 2021
3.3 years
May 4, 2016
September 7, 2021
December 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Six months
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.
Twelve months
Secondary Outcomes (2)
Diabetes Knowledge
Three months
Diabetes Knowledge (0-13)
Six months
Study Arms (2)
Enhanced Usual Care
OTHERADA Living Well with Diabetes Workbook, 15 minute in-person counseling, follow-up every 3 months
Intervention
OTHERACP 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
Interventions
American Colleges of Physicians (ACP) Living Well with Diabetes Guide
American Diabetes Association (ADA) Living Well with Diabetes Workbook
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- uncorrectable visual impairments
- hearing impairments
- cognitive impairments
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
UAMS Family Medical Center Northwest
Fayetteville, Arkansas, 72703, United States
UAMS Family Medical Center Fort Smith
Fort Smith, Arkansas, 72901, United States
UAMS Family Medical Center Jonesboro
Jonesboro, Arkansas, 72401, United States
UAMS Family Medical Center Magnolia
Magnolia, Arkansas, 71753, United States
UAMS Family Medical Center Pine Bluff
Pine Bluff, Arkansas, 71603, United States
UAMS Family Medical Center Texarkana
Texarkana, Arkansas, 71854, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kristie Hadden, PhD/Associate Professor
- Organization
- University of Arkansas for Medical Sciences
Study Officials
- PRINCIPAL INVESTIGATOR
Kristie Hadden, PhD
University of Arkansas
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2016
First Posted
May 20, 2016
Study Start
November 7, 2016
Primary Completion
February 12, 2020
Study Completion
February 12, 2020
Last Updated
December 15, 2021
Results First Posted
December 15, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- This will be available 6 months after publication of main study results.
- Access Criteria
- Require an NIH investigator with an IRB approved protocol, to conduct secondary data analysis of the available dataset.
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.