Health Literacy Intervention for African Americans With Diabetes

NCT03925948 | Completed

• 1 other identifier: IRB00061339
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Uncontrolled Diabetes

Keywords

Type 2 diabetes; African American; numeracy; self-management; glucose control

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in Diabetes knowledge measured with the validated Diabetes Knowledge Test

  baseline; 12 and 24 weeks

• Change in Diabetes self-efficacy measured with Stanford Diabetes Self-Efficacy scale

  baseline; 12 and 24 weeks

Other Outcomes (4)

• Change in Diabetes self-care index

  baseline; 12 and 24 weeks

• Change in Social support as assessed by modified Medical Outcomes Study-Social Support Survey (mMOS-SS)

  baseline; 12 and 24 weeks

• Change in Depression status as assessed by the Patient Health Questionnaire (PHQ)-9

  baseline; 12 and 24 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

This is a one arm study with all participants enrolled into this arm.

Behavioral: PLAN 4 Success-Diabetes

Interventions

PLAN 4 Success-Diabetes BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• African Americans residing in Baltimore, Maryland
• had uncontrolled diabetes (defined as HbA1C\>7%)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Wald Community Nursing Center

Baltimore, Maryland, 21205, United States

Location

Related Publications (2)

• 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.

  PMID: 18728119 BACKGROUND

• 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.

  PMID: 31410294 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Hae-Ra Han, PhD, RN

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: April 24, 2019
• Study Start: May 6, 2015
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: April 24, 2019

Record last verified: 2019-04

Locations

US (1)