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Completed

NCT Number: NCT05721482

Stress and Hypertension in Dementia Caregivers

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).

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Key information

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

College of Nursing Ohio State University

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Caregiver training

Behavioral

A trained MIM provider and dietitian will deliver the MIM DASH group intervention in eight weekly 1-hour sessions via telehealth. Participants will receive session materials so they can follow along. Each MIM session consists of material related to mindfulness-the somatic mind/body connection, relaxation, yoga, meditation, self-awareness, and bodily cues relating to emotional reactivity. Group interaction centers on sharing ideas toward effective practice and practical daily challenges to being mindful. Each class begins with a prompt for participant contemplation during the next hour that reference a unique weekly theme which will be reiterated in the session materials.

The DASH portion, led by the Registered Dietitian, focuses on education to increase vegetables, fruits, whole grains and decrease intakes of fat and sodium, sugar sweetened beverages and sweets. Education includes adapting traditional "Soul" food dishes to meet the DASH dietary guidelines.

Other names: MIM-DASH

Primary outcomes

  1. Change in Blood Pressure (Systolic)

    Time frame: Baseline, 3 months, 9 months

    Change is being assessed in systolic blood pressure measured with an automatic blood pressure cuff. Results outside of the normal range (90/60 to 120/80 mmHg), both higher and lower are considered undesirable.

  2. Change in Blood Pressure (Diastolic)

    Time frame: Baseline, 3 month, 9 month

    Change is being assessed in diastolic blood pressure measured with an automatic blood pressure cuff. Results outside of the normal range (90/60 to 120/80 mmHg), both higher and lower are considered undesirable.

  3. Change in Heart Rate

    Time frame: Baseline, 3 month, 9 month

    Change in heart rate is being assessed with an automatic blood pressure cuff. Results outside of the normal range (60 to 100 beats per minute), both higher and lower, are considered undesirable.

Secondary outcomes

  1. Newest Vital Sign

    Time frame: Baseline

    Measure of health literacy. Scores range from 0-6 with lower scores indicating lower health literacy

  2. Change is Being Assessed in Stress Management Practices Survey Part A

    Time frame: Baseline, 3 months, 9 months

    A list of 13 statements such as "I am able to use muscle relaxation techniques to reduce any tension I experience" that is measured on a Likert scale. Scores range from 0 to 52 with higher scores indicating greater use of stress management strategies.

  3. Change is Being Assessed in Perceived Stress Scale (Caregiver Stress)

    Time frame: Baseline, 3 months, 9 months

    The Perceived Stress Scale has 10-items one a Likert scale with a reference range of 0-30 regarding stress over the past month. Values are: 0 - Never, 1 - Almost Never, 2 - Sometimes, 3 - Fairly Often, 4 - Very Often The investigators will sum 10 items to create a composite score, ranging from 0 to 40.

    The higher score, the higher levels of perceived stress.

  4. Change is Being Assessed in in World Health Organization Quality of Life (WHO-5 QOL)

    Time frame: Baseline, 3 months, 9 months

    The World Health Organization (WHO-5) is a short questionnaire consisting of five Likert scale statements of well-being over the past 2-weeks. Scores range from 0-25. Higher scores represent higher quality of life

  5. Change is Being Assessed in Generalized Anxiety Symptom Scale

    Time frame: Baseline, 3 months, 9 months

    Generalized Anxiety Disorder Assessment (GAD-7) is a seven-item instrument that is used to measure or assess the severity of generalized anxiety disorder (GAD). The GAD-7 represents an anxiety measure based on seven items which are scored from zero to three. The whole scale score can range from 0 to 21 and cut-off scores for mild, moderate and severe anxiety symptoms are 5, 10 and 15 respectively.

  6. Change is Being Assessed in Revised Memory and Behavior Checklist

    Time frame: Baseline, 3 months, 9 months

    Assess psychological comorbidity of the caregiver and health status of the person living with ADRD. 32-item check-list that assess activities of daily living and problem behaviors in people living with Alzheimer's disease and related dementias (AD/ADRD). Scores range from 0-96 with higher indicating more behavioral problems in the care recipient

  7. Credibility Scale

    Time frame: 3 months

    The Credibility Scale measures attitudes towards the treatment condition and the participants' expectation of benefit once the treatment has been explained. The scale consists of 5 questions rated on a 0 (not at all confident) to 10 (very confident). The range of scores is from 0 - 50. Higher scores, up to 45, will indicate greater credibility of the treatment condition.

    There are no subscales in this tool.

  8. Acceptability Scale

    Time frame: 3 months

    Treatment-specific preference ratings (pre- and post-intervention).The participants will complete the Acceptability of Participant Preferences 13-item Likert-type survey ranging from 1 (strongly disagree) to 5 (strongly agree). Scores can range from 13 - 65. Higher scores indicate that participants find the intervention more acceptable.

    There are no subscales in this tool.

  9. Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4)

    Time frame: Baseline, 3 months, 9 months

    The K-Wood-MAS-4 is a self-report 4-item, hybrid tool developed to capture four domains of adherence behavior: self-efficacy, physical function, intentional medication-taking, and forgetfulness. The 4-item scale categorizes participants as low and high adherence. Scores range from 0 to 4 with a score of 1 or greater indicating lower prescription medication adherence.

    There are no sub-scales in this tool.

  10. Patient Health Questionnaire (PHQ-9)

    Time frame: Baseline, 3 months, 9 months

    The PHQ-9 is a 9-item measure of depression and each item is scored on a scale of 0-3. The total ranges from 0-27 (scores of 5-9 are mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; and 20 severe depression). Higher scores indicate worse depression and worse outcomes.

    There are no subscales in this tool.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Addressing the Double Jeopardy of Stress and Hypertension Among African American Female Caregivers of Persons Living With Alzheimer's Disease and Related Dementias

Acronym: MIM-DASH

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Feb 10, 2023
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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