Telephone Delivered Behavioral Skills Intervention for Blacks With T2DM (NCT00929838) | Clinical Trial Compass
CompletedNot Applicable
Telephone Delivered Behavioral Skills Intervention for Blacks With T2DM
United States256 participantsStarted 2008-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\) Age ≥18 years
* 2\) Clinical diagnosis of T2DM and HbA1c ≥9% at the screening visit
* 3\) Self-identified as Black or African American
* 4\) 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
* 5\) Subjects must be able to communicate in English
* 6\) Subjects must have access to a telephone (landline or cell phone) for the 12 week intervention period
Exclusion Criteria:
* 1\) Mental confusion on interview suggesting significant dementia
* 2\) Participation in other diabetes clinical trials
* 3\) Alcohol or drug abuse/dependency
* 4\) Active psychosis or acute mental disorder
* 5\) Life expectancy \<6 months
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Hemoglobin A1c (HbA1c) at 12 Months Post Randomization