Health Literacy Intervention for African Americans With Diabetes

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

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.

Study Overview

• Status: Completed
• Conditions: Uncontrolled Diabetes
• Intervention / Treatment: Behavioral: PLAN 4 Success-Diabetes

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Wald Community Nursing Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Intervention; This is a one arm study with all participants enrolled into this arm.

Behavioral: PLAN 4 Success-Diabetes; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Diabetes self-care index	This index included seven questions on smoking, alcohol consumption, meal planning, consumption of high fat foods, consumption of high sugar foods, consumption of sodium, and medium or high intensity exercise. These questions were coded into dichotomous responses with participation in healthy behaviors coded as "1" and active participation in negative health behaviors coded as "0". A summary score for the index could range 0-7 and higher scores indicate better self-care.	baseline; 12 and 24 weeks
Change in Social support as assessed by modified Medical Outcomes Study-Social Support Survey (mMOS-SS)	mMOS-SS is a shorter version (10 items) of the Medical Outcomes Study-Social Support Survey (MOS-SS) which includes 19 items. The original version was used to measure social support in community dwelling chronically ill persons. mMOS-SS covers emotional and instrumental domains of social support with strong evidence of reliability and validity. Example items include: "How often is someone available to take you to the doctor if you need it" or "How often is someone available who understands your problems?" Response options are from all of the time (5 point) to none of the time (1 point) with higher scores indicating higher levels of social support (total score range=10 to 50).	baseline; 12 and 24 weeks
Change in Depression status as assessed by the Patient Health Questionnaire (PHQ)-9	The Patient Health Questionnaire (PHQ)-9 addresses the severity of depressive symptoms based on the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV). The PHQ-9 has 9 items scored from 0 (not at all) to 3 (nearly every day) with total scores ranging from 0 to 27. Individuals are asked whether any symptom(s) have been experienced over the past 2 weeks. Evidence of reliability, validity, sensitivity, and specificity has been reported in community samples.	baseline; 12 and 24 weeks
Change in Quality of Life as assessed by the EuroQol Quality of Life scale	It contains the EQ-5D-3L that provides a single index of health status. The EQ-5D-3L assess five domains; mobility, self-care, usual activities, pain/discomfort and anxiety/depressions. Responses show if participants do not have difficulty, have some problems or have severe difficulty within the domains. Summary scores for the sample were created across each of the five items (range 0-2) with higher scores indicating better quality of life. A component of this scale is the EuroQol visual analogue scale (EQ-VAS) which participants can use a number from 0-100 to identify participant's health state.	baseline; 12 and 24 weeks

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Brancati Center for the Advancement of Community Care; Center for Community Innovation and Scholarship at the Johns Hopkins University; East Baltimore Medical Center; Shepherds Clinic; John Hopkins Aftercare Clinic

Publications and helpful links

General Publications

• von Wagner C, Steptoe A, Wolf MS, Wardle J. Health literacy and health actions: a review and a framework from health psychology. Health Educ Behav. 2009 Oct;36(5):860-77. doi: 10.1177/1090198108322819. Epub 2008 Aug 26.
• Han HR, Nkimbeng M, Ajomagberin O, Grunstra K, Sharps P, Renda S, Maruthur N. Health literacy enhanced intervention for inner-city African Americans with uncontrolled diabetes: a pilot study. Pilot Feasibility Stud. 2019 Aug 8;5:99. doi: 10.1186/s40814-019-0484-8. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 6, 2015
• Primary Completion (ACTUAL): February 1, 2019
• Study Completion (ACTUAL): February 1, 2019

Study Registration Dates

• First Submitted: April 22, 2019
• First Submitted That Met QC Criteria: April 22, 2019
• First Posted (ACTUAL): April 24, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 24, 2019
• Last Update Submitted That Met QC Criteria: April 22, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: self-management; Type 2 diabetes; African American; glucose control; numeracy
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: IRB00061339

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No