Health Literacy Intervention for African Americans With Diabetes

Study Overview
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Brief Summary
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Disparities in diagnosis and control of type 2 diabetes mellitus are most evident in African Americans (AAs) with lower socioeconomic status. Health literacy is an important predictor of adequate self-management and control of diabetes. The purpose of this pilot study was to test the feasibility and preliminary efficacy of a health literacy-enhanced diabetes intervention -Prevention through Lifestyle intervention And Numeracy (PLAN) 4 Success-Diabetes, in inner-city, low-income AAs with uncontrolled diabetes. To evaluate the feasibility, acceptability, and preliminary efficacy of the intervention, the investigators conducted a pilot study with 24-week follow-up. The investigators that participation in the PLAN 4 Success-diabetes intervention would be associated with a reduction in glucose outcomes and improvements in psychosocial variables.

Official Title
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Health Literacy Enhanced Intervention for Inner-city African Americans With Uncontrolled Diabetes: A Pilot Study

Conditions
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Uncontrolled Diabetes

Intervention / Treatment
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* Behavioral: PLAN 4 Success-Diabetes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: African Americans residing in Baltimore, Maryland had uncontrolled diabetes (defined as HbA1C>7%) Exclusion Criteria: Unable to give informed consent Physical or mental health conditions that could limit active participation in the study (e.g., blindness in both eyes, severe immobility, psychiatric diseases) Hematological condition that would affect HbA1C assay, e.g., hemolytic anemia, sickle cell anemia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: The investigators used a single-arm pre- and post-test design for this pilot study in which the investigators assessed the feasibility, acceptability, and preliminary efficacy of the PLAN 4 Success-Diabetes in inner-city AAs in Baltimore, Maryland. Community-dwelling AAs were recruited via referrals from inner-city federally-qualified health clinics. Nineteen of 30 participants who completed the baseline survey received the study intervention which consisted of four-week health literacy training and disease knowledge education followed by two home visits and monthly phone counseling for over 6 months.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>This is a one arm study with all participants enrolled into this arm. | Behavioral: PLAN 4 Success-Diabetes<br>* The study intervention-PLAN 4 Success-Diabetes-consisted of four 1 to 1 ½-hour weekly health literacy training and disease knowledge education sessions for four weeks (4 in-person sessions), followed by two home visits and monthly phone counseling for over 6 months (5 phone sessions). The intervention is theory-driven and builds on von Wagner's model to incorporate key elements such as health literacy, disease knowledge, and self-efficacy for better glucose outcomes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Health literacy as assessed by Literacy Assessment in Diabetes (LAD). | The Literacy Assessment in Diabetes (LAD) has high reliability and validity indices. The items on the LAD are scored as correct/incorrect, with total possible scores ranging from 0 to 60. Higher scores indicated higher health literacy levels. | baseline; 12 and 24 weeks | 
| Change in Health literacy as assessed by the Newest Vital Sign | The Newest Vital Sign consists of four items and measures numeracy. After reviewing a nutrition label, participants are asked to answer questions based on some calculation of the nutritional information (e.g., fat, sodium) presented on the label. Total possible scores range from 0 to 4, with one point assigned for each correct response. | baseline; 12 and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Diabetes knowledge measured with the validated Diabetes Knowledge Test | The Diabetes Knowledge Test assesses diabetes knowledge, medications, diet, and management with questions such as What effect will an infection most likely have on blood glucose. Correct responses are given a score of one. | baseline; 12 and 24 weeks | 
| Change in Diabetes self-efficacy measured with Stanford Diabetes Self-Efficacy scale | The Stanford Diabetes Self-Efficacy scale assesses participant's efficacy in managing diabetes and maintaining healthy lifestyles. The scale asks how confident participants are in managing different tasks such as eating meals every 4 to 5 hours every day or breakfast every day measured on a Likert scale of 0 not at all confident to 10 totally confident. Participant scores are the means across all items in the instrument. | baseline; 12 and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes, African American, numeracy, self-management, glucose control