Clinical trial NCT05734638: Stress and Blood Pressure Management for Caregivers
Official title: Self-Care and Blood Pressure for Women Caregivers of Black and African-Americans With Alzheimer's Disease or Other Memory Problems *
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Stress, Psychological
Keywords: Dementia Caregivers
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
First posted: 2023-02-21
Enrollment: 90
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Randomized control trial of behavioral intervention
Primary purpose: PREVENTION

Brief summary: Due to health and wealth disparities, no demographic group is more at risk than African American women for the double jeopardy of stress from caregiving for persons living with dementia (PLWD) and stress associated with hypertension (HTN). This double jeopardy puts those they care for in jeopardy as well: Reduced quality of life and longevity, disability, cognitive decline, and stroke associated with HTN1 impede caregiving activities and resultant health and well-being for persons living with Alzheimer's disease and related dementias (ADRD). Although successful multi-component interventions have addressed ADRD caregiver stress (REACH II) and the Savvy Caregiver program, to our knowledge there are no interventions that target the complexity of chronic caregiving stress and HTN self-care for African American women caregivers of persons living with ADRD.

This project will test two interventions for their effectiveness in improving outcomes for the target group: Mindfulness in Motion (MIM) and the Dietary Approaches to Stop Hypertension (DASH). MIM includes mindful awareness and movement from a seated position, breathing exercises, healthy sleep, and guided mindfulness meditation. The DASH component will be tailored for Black Americans. It uses a critical thinking approach that involves problem solving, participant-centered goal setting, health coaching, reflection, and development of self-efficacy (confidence) to promote physical activity and healthy eating. Solid empirical evidence demonstrates its effectiveness in reducing blood pressure among mixed-race samples.

Detailed description: Our long-term goal is to develop effective interventions to reduce cardiovascular health disparities and improve health outcomes among African American women. Given this gap in knowledge (i.e., interventions targeting caregiving stress and hypertension self-care), our Stage I pilot study focuses on a) caregiver stress and b) self-care for hypertension, the most prevalent chronic condition among African American women caregivers of PLWD. We know lifestyle changes are effective in managing HTN, but they will not make a difference in controlling hypertension if individuals do not engage in these health behaviors. Unfortunately, African American women are less likely to engage in self-care (such as diet and exercise behaviors) if they believe their hypertension is caused by stress. Indeed, our past research demonstrates that stressful interpersonal communication problems, blood pressure knowledge deficits, and complex diet information all interfered with older African American women's blood pressure self-care. Thus, we investigate the hypothesis that by addressing stress reactivity/stress resilience as the underlying mechanism to facilitate behavioral change, the intervention will be successful in enhancing HTN self-care.

A small-scale, Stage I, three-group randomized controlled trial (RCT) will investigate the feasibility of MIM plus DASH to improve blood pressure self-care in African American caregivers, as compared to MIM only or DASH only. Each intervention will be delivered in eight weekly 1-hour group sessions via telehealth.

To our knowledge, this is the first study that systematically a) examines impact on self-care behaviors and b) employs one of the Science of Behavioral Change key mechanisms underlying successful change in health behaviors-stress reactivity/stress resilience among a large, underrepresented demographic group. PI Wright will recruit 90 women with hypertension who are caring for persons living with ADRD, 30 per group (MIM DASH, MIM only, or DASH only). We will collect data at baseline, 3-months, and 6-months. The interprofessional team pursuing this project has worked together for 3 years. Our aims will be as follows:

AIM 1. Determine the feasibility of MIM DASH, MIM, and DASH for African American women caregivers of family/friends living with dementia. Hypothesis: African American women caregivers with hypertension will participate in the MIM DASH as well as the active control groups (MIM or DASH).

Aim 2. Examine pilot efficacy of the MIM DASH intervention to improve stress and self-care as compared to active control groups (MIM or DASH). Hypothesis: Stress will be reduced and self-care will be improved in the MIM DASH group as compared to active control groups (MIM or DASH).

AIM 3. Examine the pilot efficacy of the combination of MIM plus DASH for improvement of systolic blood pressure (SBP) as compared to active control groups (MIM or DASH). Hypothesis: Relative to baseline assessment, the MIM DASH group will exhibit lower SBP at 3 and 6 months as compared to active control groups (MIM or DASH).

Eligibility criteria: Inclusion criteria are (1) diagnosis of HTN treated with an antihypertensive medication; (2) age 40 and older (3) a caregiver rating of the PLWD of 2 or greater on the Alzheimer's Dementia-8 scale;50 (4) providing unpaid care to a PLWD at least 10 hours per week or assisting with at least one instrumental activity of daily living (5) self-identifies as Black/African American; (6) English speaking; and (7) has access to a telecommunications device such as the internet via desktop, laptop/tablet, smartphone, or telephone.

Exclusion criteria are (1) diagnosis of resistant HTN (blood pressure that remains above goal despite concurrent use of a diuretic/water pill and at least two other antihypertensive agents of different classes); or (2) active participation in mindfulness/yoga program.

Primary outcomes:
measure: Blood Pressure
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
measure: Hair Cortisol
timeFrame: Baseline, 6 months
measure: Block food frequency questionnaire
timeFrame: Baseline, 3 months, 6 months
measure: Daily inventory of stressful events
timeFrame: Baseline, 3 months, 6 months
measure: Perceived stress scale (caregiver stress)
timeFrame: Baseline, 3 months, 6 months
measure: Depression Anxiety Stress Symptom Scale (DASS-21)
timeFrame: Baseline, 3 months, 6 months
measure: Revised Memory and Behavior Checklist
timeFrame: Baseline, 3 months, 6 months
measure: Credibility Scale
timeFrame: 3 months
measure: Acceptability Scale
timeFrame: 3 months
measure: Krousel-Wood Medication Adherence Scale
timeFrame: Baseline, 3 months, 6 months
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, 3 months, 6 months
measure: Generalized Anxiety Disorder Scale (GAD-7)
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Kathy Wright, PhD
role: PRINCIPAL_INVESTIGATOR
References: