Clinical trial NCT05721482: Stress and Hypertension in Dementia Caregivers
Official title: Addressing the Double Jeopardy of Stress and Hypertension Among African American Female Caregivers of Persons Living With Alzheimer's Disease and Related Dementias
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypertension
Stress, Psychological
Keywords: Dementia Caregivers
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-02-10
Enrollment: 28
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: No demographic group is more at risk for the double jeopardy of caregiving stress and hypertension (HTN) than African American women caring for a family member with Alzheimer's disease and related dementias (ADRD). Both situations lead to reduced quality of life and cardiovascular disease-a complication of uncontrolled hypertension. Maintaining the health of these caregivers is critical to support the well-being of the care recipients. Although some multi-component interventions have addressed ADRD caregiver's stress and quality of life, gaps remain in targeting interventions to address the complexity of chronic caregiving stress and hypertension self-care in African American women.

This pilot study builds on the investigator's earlier work which showed that stress, blood pressure knowledge, and complex diet information deficits all interfered with older African American women's hypertension self-care. Lifestyle changes (stress management, reducing sodium, eating fruits/vegetables, and physical activity) are effective in managing hypertension. The investigator's Stage I pilot study is based on the scientific rationale that these lifestyle changes can be promoted by addressing stress reactivity/stress resilience, the psychological and physiological response of the body to stress, as the underlying mechanism to facilitate behavioral change. In this way the study can improve health outcomes (caregiver stress, quality of life, cardiovascular disease risk).

Detailed description: More than 60% of all informal Alzheimer's disease and related dementias caregiving costs are borne by African American women. Not only do these women face the known deleterious effects from caregiving stress, but also the deleterious effects from hypertension: reduced quality of life and longevity, disability, cognitive decline, and strokes. Indeed, the cumulative index of hypertension by age 55 is 75.7% for African American women compared to 40% for White women. Despite the prevalence of hypertension among African American women, to the investigator's knowledge, there are no interventions that target the complexity of chronic caregiving stress and hypertension self-care for African American women caregivers. The purpose of this pilot two-group randomized controlled pilot (N=28) is to determine the feasibility and acceptability of Mindfulness in Motion (MIM) plus the Dietary Approaches to Stop Hypertension (DASH) compared to an attention control group (Alzheimer's Association Care Training Resources) in African American caregivers with hypertension. MIM includes mindful awareness and movement from chair/standing positions, breathing exercises, healthy sleep, and guided mindfulness meditation. DASH (tailored for African Americans) 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. The attention control, Care Training consists of healthy living for participant's brain and body and effective communication. Randomized participants will receive the MIM DASH or Caregiver Training in 8 weekly 1-hour group sessions via telehealth. Both groups will receive bi-monthly coaching calls after completion of the 8-week intervention for 2-months. The central hypothesis is that by addressing caregiving stress reactivity/stress resilience, as the underlying mechanism to facilitate behavioral change, the intervention will also be successful in enhancing hypertension self-care. Study aims are to: (1) Determine the feasibility and acceptability of MIM DASH and Caregiver Training for African American women caregivers (age 40 and older) with hypertension; (2) Explore the impact of MIM DASH as compared to Caregiving Training control on caregiver stress (primary) and systolic blood pressure (secondary); and (3) Examine caregiver stress reactivity/stress resilience as the potential mechanism of action between the MIM DASH intervention and behavior change. Feasibility and acceptability data (e.g., screening to enrollment and treatment-specific preference ratings) will be collected throughout the study. Perceived stress, hair cortisol, stress resilience/stress reactivity, systolic blood pressure, self-care practice (stress management, nutrition, and physical activity) data are collected at baseline, 3-months, 3-months, and 9-months. This pilot will make a substantive contribution to the science of behavior change by identifying basic mechanisms, in the adoption of healthy behaviors, which can be used to implement self-care interventions to reduce health disparities in African Americans. Findings from the pilot study will inform the infrastructure for an R01 to the National Institutes on Aging.

Eligibility criteria: Inclusion criteria:

* diagnosis of Hypertension (HTN) treated with an antihypertensive medication;
* age 40 and older
* a caregiver rating of the People Living With Dementia (PLWD) of 2 or greater on the Alzheimer's Dementia-8 scale;
* caregiver provides unpaid care to a PLWD at least 10 hours per week or assists with at least one instrumental activity of daily living
* self-identifies as Black/African American;
* English speaking; and
* access to a telecommunications device such as the internet via desktop, laptop/tablet, smartphone, or telephone.

Exclusion criteria:

* expect to move out of the area within 9 months;
* 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
* active participation in mindfulness/yoga program. The National Institute of Aging Common Data Screening and Enrollment forms will be used to track data.

Primary outcomes:
measure: Change in Blood Pressure (Systolic)
timeFrame: Baseline, 3 months, 9 months
measure: Change in Blood Pressure (Diastolic)
timeFrame: Baseline, 3 month, 9 month
measure: Change in Heart Rate
timeFrame: Baseline, 3 month, 9 month
Secondary outcomes:
measure: Newest Vital Sign
timeFrame: Baseline
measure: Change is Being Assessed in Stress Management Practices Survey Part A
timeFrame: Baseline, 3 months, 9 months
measure: Change is Being Assessed in Perceived Stress Scale (Caregiver Stress)
timeFrame: Baseline, 3 months, 9 months
measure: Change is Being Assessed in in World Health Organization Quality of Life (WHO-5 QOL)
timeFrame: Baseline, 3 months, 9 months
measure: Change is Being Assessed in Generalized Anxiety Symptom Scale
timeFrame: Baseline, 3 months, 9 months
measure: Change is Being Assessed in Revised Memory and Behavior Checklist
timeFrame: Baseline, 3 months, 9 months
measure: Credibility Scale
timeFrame: 3 months
measure: Acceptability Scale
timeFrame: 3 months
measure: Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4)
timeFrame: Baseline, 3 months, 9 months
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, 3 months, 9 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: College of Nursing Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Kathy Wright, PhD
role: PRINCIPAL_INVESTIGATOR
References: