Clinical trial NCT03925948: Health Literacy Intervention for African Americans With Diabetes
Official title: Health Literacy Enhanced Intervention for Inner-city African Americans With Uncontrolled Diabetes: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uncontrolled Diabetes
Keywords: Type 2 diabetes
African American
numeracy
self-management
glucose control
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Brancati Center for the Advancement of Community Care
name: Center for Community Innovation and Scholarship at the Johns Hopkins University
name: East Baltimore Medical Center
name: Shepherds Clinic
name: John Hopkins Aftercare Clinic
First posted: 2019-04-24
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Health literacy as assessed by Literacy Assessment in Diabetes (LAD).
timeFrame: baseline; 12 and 24 weeks
measure: Change in Health literacy as assessed by the Newest Vital Sign
timeFrame: baseline; 12 and 24 weeks
Secondary outcomes:
measure: Change in Diabetes knowledge measured with the validated Diabetes Knowledge Test
timeFrame: baseline; 12 and 24 weeks
measure: Change in Diabetes self-efficacy measured with Stanford Diabetes Self-Efficacy scale
timeFrame: baseline; 12 and 24 weeks
Other outcomes:
measure: Change in Diabetes self-care index
timeFrame: baseline; 12 and 24 weeks
measure: Change in Social support as assessed by modified Medical Outcomes Study-Social Support Survey (mMOS-SS)
timeFrame: baseline; 12 and 24 weeks
measure: Change in Depression status as assessed by the Patient Health Questionnaire (PHQ)-9
timeFrame: baseline; 12 and 24 weeks
measure: Change in Quality of Life as assessed by the EuroQol Quality of Life scale
timeFrame: baseline; 12 and 24 weeks
Locations:
city: Baltimore
country: United States
facility: Wald Community Nursing Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Hae-Ra Han, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.