Health Beliefs, Glycemic Control, and Preventing Cognitive Decline in African Americans with Diabetes and Mild Cognitive Impairment: a Randomized Clinical Trial
Key facts
- Who runs it
- Thomas Jefferson University
- Where
- Philadelphia, United StatesSee the site
- Trial code
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 145 people enrolled
- Started
- 25 Oct 2021
- Ended
- 31 Aug 2024
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Diabetes Regulation for Eyesight and Memory
- Enhanced Usual Care
- Record updated
- 21 November 2024
Who can take part
- Age
- 65 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- African American race
- Age ≥ 65 years
- Type 2 DM
- Duration of DM ≥ 1 year
- HbA1c ≥ 7.5
- Amnestic multiple-domain MCI by NIA-AA criteria
- Able to provide written informed consent
Who cannot take part
- Dementia
- Excluded medical conditions
- Psychiatric disorders
- Life expectancy less than two years in the opinion of the PCP
- Cannot provide written consent
Where in United States
- Thomas Jefferson UniversityPhiladelphia, United States
About the trial
What the trial wants to find out
This double-masked, 2-year, single-site, phase II RCT will test the efficacy of DREAM (Diabetes Regulation for Eye Sight and Memory to prevent cognitive decline in African Americans (AAs) with amnestic multiple domain mild cognitive impairment (MCI) and poorly controlled diabetes (i.e., hemoglobin A1c [HbA1c] level ≥ 7.5%). Participants will be randomized to DREAM [11 home-based treatment sessions with a community health worker (CHW), and 4 telehealth visits with a Diabetes Nurse Educator over 2 years] or Enhanced Usual Care (EUC), which is usual care enhanced with home-based diabetes education. The primary outcome is decline in verbal memory over 2 years. Follow-up data will be collected at 6, 12, 18, and 24 months. In addition, participants will have ophthalmology assessments (at Wills) at baseline, 12 and 24 months to determine whether retinal Vessel Area Density, and/or Retinal Nerve Fiber Layer thickness mediate DREAM's treatment effect.
The 2 groups in the trial
- Diabetes Regulation for Eyesight and Memory (DREAM)Treatment being tested
DREAM is a behavioral treatment for diabetes mellitus (DM), as well as a secondary prevention strategy for dementia. DREAM acts to reinforce DM self-care and address negative beliefs about medications and physicians, which compromise glycemic control in African Americans (AAs). In DREAM, race-concordant community health workers (CHWs) will: 1) deliver in-home DM education tailored to AAs with MCI; 2) use action plans to reinforce diabetes self-care; 3) facilitate telehealth visits with a DM nurse educator to improve DM self-care and address participants' health beliefs; and 4) increase primary care physicians' (PCP) awareness of participants' cognitive deficits and health beliefs to optimize treatment of DM. .
Treatment: Diabetes Regulation for Eyesight and Memory
- Enhanced Usual Care (EUC)Existing treatment, for comparison
EUC consists of home visits by a CHW in which general DM education is provided.
Treatment: Enhanced Usual Care
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Publications
- Record updated
- 21 November 2024