Brain Connections, Self-care and Blood Pressure in Black and African Americans With Problems With Memory
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ohio State University
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Change in Systolic Blood Pressure
Study Overview
Brief Summary
This pilot randomized controlled study evaluates Mindfulness and DASH Diet resting state network and blood pressure in 36 (n=12 intervention; n=12 attention control; n = 12 control) Black and African American older adults with early Alzheimer's disease and related dementia disorders and hypertension.
Detailed Description
The purpose of this pilot randomized controlled study is to adapt a previously tested intervention to improve resting state network and blood pressure in 36 (n=12 intervention; n=12 attention control; n = 12 control) Black and African American older adults with early Alzheimer's disease and related dementia disorders and hypertension.
The study aims are to:
A.1. Establish the feasibility and acceptability of the intervention in Black and African Americans with Alzheimer's disease and related dementia disorders and hypertension.
H1: The intervention will be feasible and acceptable to Black and African Americans with Alzheimer's disease and related dementia disorders. Feasibility will be measured by recruitment, attendance, and attrition. Acceptability will be measured by a garnering feedback in a debriefing after each session.
A.2. Determine the effect size of the difference between the intervention, attention control, and control groups in resting state network connectivity and working memory and blood pressure to inform the sample size for the R01 trial.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Care Provider)
Masking Description
Data collectors masked as to the hypotheses of the study.
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of hypertension with or without medication use
- •Diagnosis of Alzheimer's disease or related dementia disorder or, if no formal diagnosis of Alzheimer's disease, then a Self-Assessment Gerocognitive Evaluation score 17-10 or a Montreal Cognitive Assessment Screen 25-19
Exclusion Criteria
- •Unable to understand spoken English
- •Expect to move out of the area within six months
- •fMRI imaging contraindicated (history of shrapnel, metal in the body, heart pacemaker, heart defibrillator, metal in the eye, gunshot wound, or some types of metal elsewhere within the body such as certain surgical clips for aneurysms in the head, heart valve prostheses, electrodes, and some other implanted devices) or claustrophobia. However, the participant can be included in the study without fMRI.
- •Self-reported history of a stroke
- •<6 on the Brief Assessment of Understanding of the Study
Arms & Interventions
Control Group
Continue care as usual without intervention.
Mindfulness plus DASH group
Receives Mindfulness and DASH Diet education once a week for 8 weeks (2.5-hour sessions)
Intervention: Mindfulness and DASH Diet Education (Behavioral)
Mindfulness plus DASH group
Receives Mindfulness and DASH Diet education once a week for 8 weeks (2.5-hour sessions)
Intervention: Education group (Behavioral)
Education Group
The sham intervention includes general education on non-health related topics such as fire-safety and learning how to dispose of medication properly, once a week for 8 weeks (2.5-hour sessions)
Intervention: Mindfulness and DASH Diet Education (Behavioral)
Education Group
The sham intervention includes general education on non-health related topics such as fire-safety and learning how to dispose of medication properly, once a week for 8 weeks (2.5-hour sessions)
Intervention: Education group (Behavioral)
Outcomes
Primary Outcomes
Change in Systolic Blood Pressure
Time Frame: Baseline and 3 months
Omron automatic blood pressure machine with small and large cuff sizes will be used to obtain blood pressure readings
Change in Resting State Network
Time Frame: Baseline and 3 months
functional magnetic resonance imaging scans of brains utilizing and working memory test will be employed to measure change in resting state network
Change in Diastolic Blood Pressure
Time Frame: Baseline and 3 months
Omron automatic blood pressure machine with small and large cuff sizes will be used to obtain blood pressure readings
Secondary Outcomes
- Dietary Approaches to Stop Hypertension Questionnaire (DASH-Q) Change(Baseline and 3 months)
- Cognitive and Affective Mindfulness Scale Change(Baseline and 3 months)
- Perceived Stress Scale Change(Baseline and 3 months)
Investigators
Kathy D. Wright
Assistant Professor
Ohio State University