Stress and Hypertension in Dementia Caregivers

Hypertension Clinical Trial

— MIM-DASH  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05721482
• Other study ID #: 2022B0031
• Secondary ID: R21AG077069
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 17, 2023
• Est. completion date: October 15, 2024

Study information

• Verified date: June 2024
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 28
• Est. completion date: October 15, 2024
• Est. primary completion date: October 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

Inclusion criteria:

• diagnosis of HTN treated with an antihypertensive medication;

• age 40 and older

• a caregiver rating of the 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 NIA Common Data Screening and Enrollment forms will be used to track data.

Related Conditions & MeSH terms

• Dementia
• Hypertension
• Stress, Psychological

Intervention

Behavioral:
• Caregiver Training
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.

Locations

Country	Name	City	State
United States	College of Nursing Ohio State University	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Blood Pressure	Change is being assessed in systolic and diastolic blood pressure measured with automatic blood pressure cuff. Results outside of the normal range (90/60 to 120/80 mmHg), both higher and lower are considered undesirable.	Baseline, 3 months, 9 months
Secondary	Change is being assessed in Hair Cortisol	Hair cortisol (HC) will be used as a proxy for chronic stress. Approximately 25-75 mg of hair will be cut from the posterior vertex region of the scalp as close to the scalp as possible. Participants will be surveyed on corticosteroid use as these medications may suppress cortisol levels, and on their hair care practices, such as frequency of washing, chemical treatments and hair product use. Hair Cortisol levels are expressed in hair as pg/mg and generally logged due to skewed distributions as needed. Higher levels of cortisol indicated higher levels of chronic stress and a less desirable outcome.	Baseline, 9 months
Secondary	Newest Vital Sign	Measure of health literacy. Scores range from 0-6 with lower scores indicating lower health literacy	Baseline
Secondary	Change is being assessed in Stress Management Practices survey part A	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.	Baseline, 3 months, 9 months
Secondary	Change is being assessed in the Pittsburgh Stress Battery	BP response to stress that is indicated as a measure of stress reactivity by the Science of Behavior Change Research Network. The participants are given a series of tests that include the Stroop test, mirror tracing, and mental math. For example, participants will be given three trials of basic arithmetic problems lasting one minute per trial. Higher blood pressure scores indicate higher levels of stress reactivity and a less desirable outcome.	Baseline, 3 months, 9 months
Secondary	Changes is being assessed in the Block food frequency questionnaire	Block Food Frequency Questionnaire (includes physical activity) is a validated measure with a food and beverage list that includes 127 items, plus supplementary questions to allow for the adjustment of fat, protein, carbohydrate, sugar, and whole grain content. The questionnaire ascertains the frequency with which each food or beverage was usually consumed, and offers nine continuous responses ranging from "never" to "every day" for most foods. The DASH Index that is calculated using data from the Block Food Frequency Questionnaire uses a quintile system to score foods related to the DASH diet. All of the components are equally weighted. Intake of vegetables, fruits (including fruit juice), nuts and legumes, whole grains were scored from 1 (lowest quintile) to 5 (highest quintile). The overall DASH component scores range from 8 to 40. With higher scores indicating healthier diets	Baseline, 3 months, 9 months
Secondary	Change is being assessed in Daily inventory of stressful events	The instrument is a semi-structured survey in which participants report whether any stressful events had occurred within the past 24 hours. This instrument yields several variables for each reported stressor including: (a) content classification of the stressor for example, work overload, argument over housework, or traffic problem); (b) subjective severity of stressors; (c) primary appraisals (areas of life that were at risk because of the stressor); and (d) perceived control of the situation." Scores range from 0 to 27. Higher scores indicate more stressful events.	Baseline, 3 months, 9 months
Secondary	Change is being assessed in Perceived stress scale (caregiver stress)	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.	Baseline, 3 months, 9 months
Secondary	Change is being assessed in in World Health Organization Quality of Life (WHO-5 QOL)	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	Baseline, 3 months, 9 months
Secondary	Change is being assessed in Generalized Anxiety Symptom Scale	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.	Baseline, 3 months, 9 months
Secondary	Change is being assessed in Revised Memory and Behavior Checklist	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 ADRD. Scores range from 0-96 with higher indicating more behavioral problems in the care recipient	Baseline, 3 months, 9 months
Secondary	Credibility Scale	The Credibility Scale (a = 0.86) 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). Higher scores, up to 45, will indicate greater credibility of the treatment condition.	3 months
Secondary	Acceptability Scale	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). Higher scores indicate that participants find the intervention more acceptable.	3 months
Secondary	Change is being assessed in Krousel-Wood Medication Adherence Scale	The 4-Item scale captures four domains of adherence behavior. Scores range from 0 to 4 with a score of 1 or greater indicating lower adherence.	Baseline, 3 months, 9 months
Secondary	Change in depression will be assessed in the PHQ-9	The PHQ-9 is a 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)	Baseline, 3 months, 9 months