跳至主要内容
临床试验/NCT05721482
NCT05721482已完成不适用

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

Ohio State University2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2023年1月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
2
主要终点
Change in Blood Pressure (Systolic)

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
None

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in Blood Pressure (Systolic)

时间窗: 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.

Change in Blood Pressure (Diastolic)

时间窗: 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.

Change in Heart Rate

时间窗: 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.

次要结局

  • Newest Vital Sign(Baseline)
  • Change is Being Assessed in Stress Management Practices Survey Part A(Baseline, 3 months, 9 months)
  • Change is Being Assessed in in World Health Organization Quality of Life (WHO-5 QOL)(Baseline, 3 months, 9 months)
  • Change is Being Assessed in Perceived Stress Scale (Caregiver Stress)(Baseline, 3 months, 9 months)
  • Change is Being Assessed in Generalized Anxiety Symptom Scale(Baseline, 3 months, 9 months)
  • Change is Being Assessed in Revised Memory and Behavior Checklist(Baseline, 3 months, 9 months)
  • Credibility Scale(3 months)
  • Acceptability Scale(3 months)
  • Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4)(Baseline, 3 months, 9 months)
  • Patient Health Questionnaire (PHQ-9)(Baseline, 3 months, 9 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kathy D. Wright

Assistant Professor

Ohio State University

研究点 (2)

Loading locations...

相似试验