Clinical trial NCT03736434: Brain Connections and Blood Pressure
Official title: Brain Connections, Self-care and Blood Pressure in Black and African Americans With Problems With Memory
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Mild Cognitive Impairment
Keywords: Mindfulness
Blood pressure
Hypertension
Mild Cognitive impairment (MCI)
functional Magnetic resonance Imaging (fMRI)
Hair cortisol
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2018-11-09
Enrollment: 38
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three aim randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

H2: We hypothesize that compared to both control groups; the intervention group will have greater improvement in process measures of self-management mechanisms (self-efficacy, self-regulation, and emotion regulation), chronic stress, diet, and physical activity. The functional magnetic resonance imaging and blood pressure will be obtained at baseline and 3 months. The intervention group (Mindfulness + DASH) will have improved resting state network connectivity and blood pressure as compared to the attention control (2-hour group social time and brief lecture on a non-diet/mindfulness topic such as personal safety, fire safety, and disaster preparedness) and the control group (care as usual with no intervention). The Center for Cognitive and Behavioral Brain Imaging, Arts \& Sciences co-investigators will analyze imaging data using their newly published statistical network model to quantify the subnetwork structures of the resting state network and evaluate changes of their topological properties.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Resting State Network
timeFrame: Baseline and 3 months
measure: Change in Systolic Blood Pressure
timeFrame: Baseline and 3 months
measure: Change in Diastolic Blood Pressure
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Dietary Approaches to Stop Hypertension Questionnaire (DASH-Q) Change
timeFrame: Baseline and 3 months
measure: Cognitive and Affective Mindfulness Scale Change
timeFrame: Baseline and 3 months
measure: Perceived Stress Scale Change
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University College of Nursing
state: Ohio
Study officials:
affiliation: Ohio State University
name: Kathy D Wright, PhD
role: PRINCIPAL_INVESTIGATOR
References: