Atlanta, Georgia 30338

  • Diabetes Mellitus, Type 2

Purpose:

The main purpose of the study is to assess the feasibility and acceptability of a Culturally-Tailored Cognitive Behavior intervention (CT-CB) for African American patients with uncontrolled Type 2 diabetes. After the baseline visit subjects will be randomly assigned to undergo a six session group-based or web-based behavioral intervention (CT-CB) program or to general education (usual care). The intervention duration is 12 weeks.


Study summary:

African Americans are approximately twice as likely to be diagnosed with diabetes and to experience gaps in diabetes care compared to Whites. Lower health literacy and socio-economic, language, and communication barriers are all associated with disparities in diabetes care. The role of Behavioral theory is foundational in understanding behavior change among patients in the self-management of diabetes. Further culturally tailoring increases acceptance and effectiveness of diabetes self-management. The aim of this pilot study is to test the feasibility and acceptability of a culturally tailored, cognitive behavioral intervention (CT-CB) program using a group-based vs. a web-based format, and determine if it can improve diabetes self-management among African Americans compared with usual individual based care at the clinic. Forty-five African American patients with uncontrolled type 2 diabetes (HbA1C > 8 %), aged > 18 years, will be randomly assigned to undergo a six session group-based or web-based behavioral intervention (CT-CB) program or to general education (usual care). After 12 weeks, patients will be followed for an additional three months to evaluate for diminution of treatment effects. Both the group -based and the web-based CBT intervention group will be followed for an additional three months to study for possible diminution of treatment effects over time. Diabetic measures like Hemoglobin (HbA1C) at baseline vs. 3 months; the Patient Health Questionnaire to assess depressive symptoms; Diabetes Distress Scale, anxiety, self-efficacy, quality of life (SF-12), Diabetes Health Belief Scale, process measures such as Patient Activation Measure (PAM-13), medication adherence questionnaire, session-participation, glucose self-monitoring, diet and physical activity are measured at each visit pre and post intervention. Trained study staff will also conduct neuropsychological tests including language and memory tests, attention and executive function tests, clinical diagnosis, activities of daily living (ADL).


Criteria:

Inclusion Criteria: - Age: 18 years or older - Fluency in English - African American - HbA1C>8% Exclusion Criteria: - Subjects with no web access, - Subjects using an insulin pump, - Subjects that are pregnant - Subjects that have active substance abuse including alcohol, - Subjects with visual impairment or have severe hearing or other physical disabilities that would be a barrier for participating in-group or web sessions


NCT ID:

NCT03562767


Primary Contact:

Principal Investigator
Ambar Kulshreshtha, MD, PhD FAHA
Emory University

Ambar Kulshreshtha, MD, PhD FAHA
Phone: 404-778-6920
Email: akulshr@emory.edu


Backup Contact:

N/A


Location Contact:

Atlanta, Georgia 30338
United States

Ambar Kulshreshtha
Phone: 404-778-6920
Email: akulshr@emory.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 18, 2021

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