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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02779556
Enrollment
756
Registered
2016-05-20
Start date
2016-11-07
Completion date
2020-02-12
Last updated
2021-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

Health Literacy, Diabetes

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. 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.

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.

Interventions

OTHERACP Living with Diabetes Guide

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

OTHERADA Living Well with Diabetes Workbook

American Diabetes Association (ADA) Living Well with Diabetes Workbook

Sponsors

Northwestern University
CollaboratorOTHER
Louisiana State University Health Sciences Center Shreveport
CollaboratorOTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
University of Arkansas
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Hemoglobin A1C (HbA1C)Six monthsHbA1C 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.

Secondary

MeasureTime frameDescription
Diabetes KnowledgeThree monthsA 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.
Diabetes Knowledge (0-13)Six monthsA 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Enhanced Usual Care
ADA Living Well with Diabetes Workbook, 15 minute in-person counseling, follow-up every 3 months ADA Living Well with Diabetes Workbook: American Diabetes Association (ADA) Living Well with Diabetes Workbook
394
Intervention
ACP 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 ACP Living with Diabetes Guide: American Colleges of Physicians (ACP) Living Well with Diabetes Guide
362
Total756

Withdrawals & dropouts

PeriodReasonFG000FG001
12 Month HbA1cNo value collected during window138102
3 MonthsLost to Follow-up4029
3 MonthsMissed 3 month clinic visit2719
6 MonthLost to Follow-up3339
6 Month HbA1cNo value collected during window6950
BaselinePartial baseline interview completed10

Baseline characteristics

CharacteristicEnhanced Usual CareTotalIntervention
Age, Continuous55.4 years
STANDARD_DEVIATION 11.8
55.8 years
STANDARD_DEVIATION 11.7
56.1 years
STANDARD_DEVIATION 11.4
Education
College Graduate
40 Participants90 Participants50 Participants
Education
High School Graduate
141 Participants268 Participants127 Participants
Education
Less than High School
87 Participants153 Participants66 Participants
Education
Refused to answer question
0 Participants2 Participants2 Participants
Education
Some College
126 Participants243 Participants117 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants11 Participants6 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
388 Participants741 Participants353 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants4 Participants3 Participants
Health Literacy (NVS)
Adequate
184 Participants363 Participants179 Participants
Health Literacy (NVS)
Limited
210 Participants393 Participants183 Participants
Race (NIH/OMB)
American Indian or Alaska Native
5 Participants7 Participants2 Participants
Race (NIH/OMB)
Asian
1 Participants2 Participants1 Participants
Race (NIH/OMB)
Black or African American
220 Participants411 Participants191 Participants
Race (NIH/OMB)
More than one race
1 Participants5 Participants4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants4 Participants3 Participants
Race (NIH/OMB)
White
166 Participants326 Participants160 Participants
Sex: Female, Male
Female
275 Participants510 Participants235 Participants
Sex: Female, Male
Male
119 Participants246 Participants127 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
6 / 3943 / 362
other
Total, other adverse events
0 / 3940 / 362
serious
Total, serious adverse events
0 / 3940 / 362

Outcome results

Primary

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.

Time frame: Six months

Population: 119 individuals were excluded from analysis, because they did not have a 6 month HbA1c value within the designated window.

ArmMeasureValue (LEAST_SQUARES_MEAN)
Enhanced Usual CareHemoglobin A1C (HbA1C)8.4 Percentage of glycated hemoglobin
InterventionHemoglobin A1C (HbA1C)8.3 Percentage of glycated hemoglobin
Primary

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.

Time frame: Twelve months

Population: 240 individuals were excluded from analysis, because they did not have a 12 month HbA1c value within the designated window.

ArmMeasureValue (LEAST_SQUARES_MEAN)
Enhanced Usual CareHemoglobin A1C (HbA1C)8.5 Percentage of glycated hemoglobin
InterventionHemoglobin A1C (HbA1C)8.4 Percentage of glycated hemoglobin
Secondary

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.

Time frame: Three months

Population: 116 participants were excluded, missed 3 month visit.

ArmMeasureValue (LEAST_SQUARES_MEAN)
Enhanced Usual CareDiabetes Knowledge9.2 Score on a scale
InterventionDiabetes Knowledge9.3 Score on a scale
Secondary

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.

Time frame: Six months

Population: 142 participants were excluded, missed 6 month visit.

ArmMeasureValue (LEAST_SQUARES_MEAN)
Enhanced Usual CareDiabetes Knowledge (0-13)9.5 Score on a scale
InterventionDiabetes Knowledge (0-13)9.7 Score on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026