Telephone Delivered Behavioral Skills Intervention for Blacks With T2DM
DM-TBSI
4 other identifiers
interventional
256
1 country
1
Brief Summary
Blacks or African Americans have greater risk of and are more likely to die from type 2 diabetes (T2DM). Major barriers to effective diabetes care for Blacks include poor diabetes knowledge, self-management skills, empowerment, and perceived control. Few prior studies have tested interventions to address these barriers in combination, especially among Blacks who have the greatest burden of diabetes related complications. This study provides a unique opportunity to address this gap in the literature by testing the efficacy of separate and combined telephone-delivered, diabetes knowledge and motivation/behavioral skills training intervention in high risk Blacks with poorly controlled T2DM. The findings of this study, if successful, will provide new information on how to improve quality of care for diabetes in ethnic minorities and reduce the disproportionate burden of diabetes complications and deaths in this population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started Aug 2008
Longer than P75 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 29, 2009
CompletedFirst Posted
Study publicly available on registry
June 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedResults Posted
Study results publicly available
April 10, 2019
CompletedJuly 12, 2024
July 1, 2024
7.8 years
June 29, 2009
May 14, 2018
July 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hemoglobin A1c (HbA1c) at 12 Months Post Randomization
12-months post randomization
Study Arms (4)
Diabetes Knowledge/Information Arm
EXPERIMENTALSubjects randomized to the diabetes knowledge/information arm will complete 12 diabetes education modules over a 12-week period. The educational materials were developed based on guidelines for diabetes education by the American Diabetes Association. The content is based on the principles of the Adult Learning Theory. The information is designed to be relevant, person centered, and presented in a non-threatening manner. The modules are designed to be delivered via telephone in 10-15 minutes, so that the maximum contact time per telephone call including introduction and closing would not exceed 30 minutes.
Motivation/Behavioral Skills Arm
EXPERIMENTALThe motivation/behavioral skills intervention consists of patient activation (list of 5 questions to ask their provider at every visit and training on how to ask the questions), patient empowerment (diabetes responsibility contracts, personal goals, and flow charts for patients to record lab results/medications and training on how to use the empowerment tools), and behavioral skills training delivered via telephone lasting 30 minutes every week for 12 weeks. The behavioral skills training will be focused on 4 behaviors - physical activity, diet, medication adherence, and glucose self-monitoring. Guided by subjects' current problem areas and preferences, subjects will be asked to choose 1 of 4 behaviors to focus on every 3 weeks (4 behaviors over 12 weeks).
Combined Intervention Arm
EXPERIMENTALThe combined intervention group will receive weekly telephone-delivered diabetes knowledge/information, patient activation (list of 5 questions to ask their provider at every visit and training on how to ask the questions), patient empowerment (diabetes responsibility contracts, personal goals, and flow charts for patients to record lab results/medications and training on how to use the empowerment tools), and behavioral skills training delivered via telephone. The behavioral skills training will be focused on 4 behaviors and guided by subjects' current problem areas and preferences, subjects will be asked to choose 1 of 4 behaviors to focus on every 3 weeks. The combined intervention group telephone sessions will last for 30 minutes.
Usual Care Arm
SHAM COMPARATORThe usual care group will receive weekly telephone-delivered general health education lasting 30 minutes for 12 weeks to control for attention. Patients in the usual care group will continue to receive any usual diabetes education provided by the clinic staff; however, they will not receive targeted diabetes knowledge/information, activation, empowerment, or behavioral skills training.
Interventions
This group will receive telephone-delivered diabetes knowledge/information lasting 30 minutes for 12 weeks.
This intervention consists of patient activation, patient empowerment, and behavioral skills training delivered via telephone lasting 30 minutes every week for 12 weeks.
This group will receive all components of the diabetes knowledge/information and the motivation/behavioral skills interventions via telephone lasting 30 minutes every week for 12 weeks.
This group will receive telephone-delivered general health education lasting 30 minutes for 12 weeks to control for attention and content.
Eligibility Criteria
You may qualify if:
- \) Age ≥18 years
- \) Clinical diagnosis of T2DM and HbA1c ≥9% at the screening visit
- \) Self-identified as Black or African American
- \) Subject must be taking at least one oral medication for diabetes, hypertension, or hyperlipidemia and must be willing to use the MEMS cap and bottle for 12 months
- \) Subjects must be able to communicate in English
- \) Subjects must have access to a telephone (landline or cell phone) for the 12 week intervention period
You may not qualify if:
- \) Mental confusion on interview suggesting significant dementia
- \) Participation in other diabetes clinical trials
- \) Alcohol or drug abuse/dependency
- \) Active psychosis or acute mental disorder
- \) Life expectancy \<6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Related Publications (2)
Egede LE, Strom JL, Durkalski VL, Mauldin PD, Moran WP. Rationale and design: telephone-delivered behavioral skills interventions for Blacks with Type 2 diabetes. Trials. 2010 Mar 29;11:35. doi: 10.1186/1745-6215-11-35.
PMID: 20350322BACKGROUNDEgede LE, Williams JS, Voronca DC, Gebregziabher M, Lynch CP. Telephone-Delivered Behavioral Skills Intervention for African American Adults with Type 2 Diabetes: A Randomized Controlled Trial. J Gen Intern Med. 2017 Jul;32(7):775-782. doi: 10.1007/s11606-017-4023-0. Epub 2017 Mar 23.
PMID: 28337686RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jennifer Campbell
- Organization
- Medical College of Wisconsin
Study Officials
- PRINCIPAL INVESTIGATOR
Leonard E Egede, MD, MS
Medical University of South Carolina (MUSC)
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor & Chair, Department of Medicine
Study Record Dates
First Submitted
June 29, 2009
First Posted
June 30, 2009
Study Start
August 1, 2008
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
July 12, 2024
Results First Posted
April 10, 2019
Record last verified: 2024-07