A Randomized Single Blinded Interventional Study to Assess the Feasibility and Acceptability of a Culturally-Tailored Cognitive Behavior Intervention (CT-CB) for African American Patients With Uncontrolled Type 2 Diabetes and to Compare the Effects of Intervention to Standard of Care on Diabetes Control Measures.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Emory University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Percentage of Participants That Are Enrolled and Attend the Study the Study Sessions Compared to Enrolled
Study Overview
Brief Summary
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.
Detailed Description
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Masking Description
Research staff conducting the psychological, physical, outcome assessments, and study analyses will be blinded to participant's group allocation. To minimize bias, participants in the intervention group will be asked to refrain from disclosing their group assignment to study staff who collect data and questionnaires. Due to the overt nature of the CT-CB approach, the investigators and participants in the intervention group will not be blinded.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Group-based Cognitive Behavioral Intervention
Subjects receiving the group-based CT-CB intervention
Intervention: Group-based Cognitive Behavioral Intervention (Behavioral)
Web-based Cognitive Behavioral Intervention
Subjects receiving the web based CT-CB intervention
Intervention: Web-based Cognitive Behavioral Intervention (Behavioral)
Usual Care
Subjects receiving usual care from their primary care providers
Intervention: Usual Care (Behavioral)
Outcomes
Primary Outcomes
Percentage of Participants That Are Enrolled and Attend the Study the Study Sessions Compared to Enrolled
Time Frame: 3 months post randomization
Acceptability of the intervention will be operationalized as study session attendance and will be considered adequate if at least 70% of the sessions are attended.
Percentage of Participants That Complete the Study Compared to Enrolled
Time Frame: 3 months post randomization
Feasibility of the intervention will be measured as the percentage of participants who complete the study. The intervention will be considered feasible if no more than 20% of participants are lost to follow up.
Secondary Outcomes
- Change in Diabetes Health Belief Scale(Baseline and 3 months post randomization)
- Change in Hemoglobin A1c (HbA1C) Level(Baseline and 3 months post randomization)
- Change in Diabetes Distress Scale (DDS17) Score(Baseline and 3 months post randomization)
- Change in Patient Health Questionnaire (PHQ-9) Score(Baseline and 3 months post randomization)
- Change in Generalized Anxiety Disorder 7-item (GAD-7) Scale Score(Baseline and 3 months post randomization)
- Change in Self Efficacy for Diabetes(Baseline and 3 months post randomization)
- Change in 12-Item Short Form Health Survey (SF-12) Score(Baseline and 3 months post randomization)
Investigators
Ambar Kulshreshtha
Assistant Professor, Department of Family and Preventive Medicine
Emory University