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Cognitive Behavioral Therapy for African Americans With Uncontrolled Type-2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03562767
Recruitment Status : Suspended (Study activities are suspended due to COVID-19 pandemic)
First Posted : June 19, 2018
Last Update Posted : May 4, 2020
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Ambar Kulshreshtha, Emory University

Tracking Information
First Submitted Date  ICMJE June 8, 2018
First Posted Date  ICMJE June 19, 2018
Last Update Posted Date May 4, 2020
Actual Study Start Date  ICMJE December 5, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 8, 2018)
  • Feasibility [ 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.
  • Acceptability [ 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2018)
  • Change in Hemoglobin A1c (HbA1C) Level [ Time Frame: Baseline and 3 months post randomization ]
    Hemoglobin A1c (HbA1C) in % will be measured via blood draw and processing. Normal values HbA1C are less than 5.7%, values between 5.7% and 6.4% indicate pre-diabetes, and persons with levels of 6.5% or higher are considered to have diabetes.
  • Change in Patient Health Questionnaire (PHQ-9) Score [ Time Frame: Baseline and 3 months post randomization ]
    Depressive symptoms are assessed by the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a 9-item scale where respondents indicate how much they are bothered by certain problems on a 4-point scale where 0 = not at all and 3 = nearly every day. Total scores range from 0 to 27 with degree of depression considered minimal for scores between 0-4, mild for scores of 5-9, moderate for scores of 10-14, moderate to severe for scores 15-19, and severe for scores of 20-27.
  • Change in Diabetes Distress Scale (DDS17) Score [ Time Frame: Baseline and 3 months post randomization ]
    The Diabetes Distress Scale (DDS17) is a 17-item questionnaire assessing the severity of problems of living with diabetes. Participants indicate the degree to which each item impacts their life on a 6-point scale where 1 = not a problem and 6 = a very serious problem. The scores are summed and divided by 17 to generate an average score that can range from 1 to 6. Scores of 3 or more are considered high distress.
  • Change in 12-Item Short Form Health Survey (SF-12) Score [ Time Frame: Baseline and 3 months post randomization ]
    Quality of life will be assessed with the 12-Item Short Form Health Survey (SF-12). The Short Form-12 Health Survey Questionnaire (SF-12) is a measure of general physical and mental health. The SF-12 consists of 12 items with a Likert-type response format that measures quality of life with a Physical Component Summary (PCS) and Mental Component Summary (MCS). Subscales associated with the PCS include physical functioning, role limitations due to physical problems, bodily pain, and general health perceptions. Subscales associated with the MCS include vitality (energy and fatigue), social functioning, role limitations due to emotional problems, and mental health. A scoring algorithm is used to generate a total score for each component ranging from 0 to 100. Low values represent a poor health state while high values represent a good health state.
  • Change in Generalized Anxiety Disorder 7-item (GAD-7) Scale Score [ Time Frame: Baseline and 3 months post randomization ]
    Anxiety will be assessed using the Generalized Anxiety Disorder 7-item (GAD-7) Scale. Participants use a 4-point scale in response to statements about anxiety (such as "trouble relaxing") to indicate how bothered they have felt by item over the last two weeks. Degree of anxiety is rated as 0 = "not at all" to 3 = "nearly every day". Total scores range from 0 to 21. Scores of 5-9 indicate mild anxiety, 10-15 indicates moderate anxiety and scores 15 and greater indicate severe anxiety.
  • Change in Self Efficacy for Diabetes [ Time Frame: Baseline and 3 months post randomization ]
    Change in Self Efficacy is assessed by Self Efficacy for Diabetes Scale that is administered at Baseline and at 3rd month post randomization. The questionnaire is a 8 item scale. Each question ranks from 1(not confident at all) to 10 (totally confident). The scale score will be compared from Baseline to 3 months post randomization
  • Change in Diabetes Health Belief Scale [ Time Frame: Baseline and 3 months post randomization ]
    Change in Diabetes Health Belief Scale is assessed by 25-item scale that is administered at baseline and at 3 months post randomization.Each question ranks from (1 = Strongly Disagree) to (5 = Strongly Agree).The scale score will be compared from Baseline to 3 months post randomization
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive Behavioral Therapy for African Americans With Uncontrolled Type-2 Diabetes
Official Title  ICMJE 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Three groups of subjects with uncontrolled diabetes Type 2 will be followed longitudinally for 3 months
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.
Primary Purpose: Supportive Care
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Behavioral: Group-based Cognitive Behavioral Intervention
    This intervention will include six 1-hour group sessions held biweekly for twelve weeks. Each sixty-minute session will consist of 15 minutes of diabetes education regarding exercise and food planning and approximately 45 minutes of CT-CB presentations/engagement activities. Participants will be encouraged to bring along their family members or friends for support.
  • Behavioral: Web-based Cognitive Behavioral Intervention
    This intervention will include six 1-hour web-based sessions held biweekly for twelve weeks. Subjects in the web-based CT-CB will be asked to reserve a 1 hour period for a web call from the Behavioral Interventionist team. Text reminders will be sent to the participants prior the sessions. During this period, approximately 15 minutes will be reserved for diabetes exercise and food planning education and approximately 45 minutes of CT-CB engagement activities.
  • Behavioral: Usual Care
    Usual care group participants will continue to receive care and follow up from their primary care providers as per the American Diabetes Association guidelines with log books, education regarding self-management strategies and appropriate referrals as needed.
Study Arms  ICMJE
  • Experimental: Group-based Cognitive Behavioral Intervention
    Subjects receiving the group-based CT-CB intervention
    Intervention: Behavioral: Group-based Cognitive Behavioral Intervention
  • Experimental: Web-based Cognitive Behavioral Intervention
    Subjects receiving the web based CT-CB intervention
    Intervention: Behavioral: Web-based Cognitive Behavioral Intervention
  • Placebo Comparator: Usual Care
    Subjects receiving usual care from their primary care providers
    Intervention: Behavioral: Usual Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: June 8, 2018)
45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03562767
Other Study ID Numbers  ICMJE IRB00101847
P30DK111024 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ambar Kulshreshtha, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Ambar Kulshreshtha, MD, PhD FAHA Emory University
PRS Account Emory University
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP