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Stress and Blood Pressure Management for Caregivers (Stress/HTN)

Primary Purpose

Hypertension, Stress, Psychological

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MIM-DASH
MIM Only
DASH Only
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension focused on measuring Dementia Caregivers

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Ohio State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

MIM-DASH

MIM Only

DASH Only

Arm Description

A trained MIM provider (layperson) and a registered dietitian will deliver the MIM DASH group intervention in eight 1-hour (30 minutes MIM and 30 minutes DASH) sessions via telehealth (video and telephone access).

The MIM-only intervention group will receive the MIM education only in eight weekly sessions of 30 minutes each. To maintain equipoise among the intervention groups, this group will also have 30 minutes of "social time" to interact with the trainer and peers.

The DASH-only group will receive the DASH education only in eight weekly sessions of 30 minutes each. This group will also have 30 minutes of "social time" to interact with the trainer and peers, will receive their education from a different interventionist (also a registered dietician) and receive two coaching calls per month for 3 months, in this case focused on healthy eating DASH principles.

Outcomes

Primary Outcome Measures

Blood Pressure
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.

Secondary Outcome Measures

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.
Newest Vital Sign
Measure of health literacy. Scores range from 0-6 with lower scores indicating lower health literacy
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.
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.
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
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.
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.
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
Depression Anxiety Stress Symptom Scale (DASS-21)
Assess psychological comorbidity of the caregiver and health status of the person living with ADRD. Contains 21 items to evaluate mild, moderate, or severe depression, anxiety, and stress (α =0.79). Scores range from 0-37 with higher scores indicating more symptoms.
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
Credibility Scale
The Credibility Scale (α = 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.
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.
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.
Behavioral Risk Factor Surveillance System-physical activity (BRFSS)
BRFSS is used to track health conditions and risk behaviors, with this module tracking physical activity
Diet History Questionnaire (DHQ) III
DHQ is a food frequency questionnaire for use with adults 19 or more years of age to assess food and dietary supplement intakes.

Full Information

First Posted
November 10, 2022
Last Updated
September 26, 2023
Sponsor
Ohio State University
Collaborators
Robert Wood Johnson Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05734638
Brief Title
Stress and Blood Pressure Management for Caregivers
Acronym
Stress/HTN
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 11, 2023 (Actual)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
September 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
Robert Wood Johnson Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Stress, Psychological
Keywords
Dementia Caregivers

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Randomized control trial of behavioral intervention
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MIM-DASH
Arm Type
Experimental
Arm Description
A trained MIM provider (layperson) and a registered dietitian will deliver the MIM DASH group intervention in eight 1-hour (30 minutes MIM and 30 minutes DASH) sessions via telehealth (video and telephone access).
Arm Title
MIM Only
Arm Type
Experimental
Arm Description
The MIM-only intervention group will receive the MIM education only in eight weekly sessions of 30 minutes each. To maintain equipoise among the intervention groups, this group will also have 30 minutes of "social time" to interact with the trainer and peers.
Arm Title
DASH Only
Arm Type
Experimental
Arm Description
The DASH-only group will receive the DASH education only in eight weekly sessions of 30 minutes each. This group will also have 30 minutes of "social time" to interact with the trainer and peers, will receive their education from a different interventionist (also a registered dietician) and receive two coaching calls per month for 3 months, in this case focused on healthy eating DASH principles.
Intervention Type
Behavioral
Intervention Name(s)
MIM-DASH
Intervention Description
Randomized participants will receive the MIM DASH, MIM or DASH intervention in eight weekly, 1-hour group sessions via telehealth (video and telephone access). Participants will receive session materials such as PowerPoint presentations so they can follow along by phone or videoconferencing. After completion of the eight weekly sessions, the participants will receive one follow-up call every other week for 8 weeks. The 3- and 6-month data will be collected as listed in the study AIMs. A manual of operations will detail all procedures related to the protocol, including participant recruitment, data collection, database usage, and database management.
Intervention Type
Behavioral
Intervention Name(s)
MIM Only
Intervention Description
The MIM-only intervention group will receive the MIM education only in eight weekly sessions of 30 minutes each. To maintain equipoise among the intervention groups, this group will also have 30 minutes of "social time" to interact with the trainer and peers. To avoid cross contamination, the interventionist will not also deliver the intervention to the MIM DASH group. Each participant will have access to the digital meditations with mindfulness practice recordings as well as a weekly diary to document study activities. Participants will be instructed to perform mindfulness meditations at least five times a week and record the time in their diary. After completion of the eight weekly sessions, these participants will receive six coaching calls (two per month for 3 months) focused on mindfulness practice.
Intervention Type
Behavioral
Intervention Name(s)
DASH Only
Intervention Description
The DASH-only group will receive the DASH education only in eight weekly sessions of 30 minutes each. This group will also have 30 minutes of "social time" to interact with the trainer and peers, will receive their education from a different interventionist (also a registered dietician) and receive two coaching calls per month for 3 months, in this case focused on healthy eating DASH principles.
Primary Outcome Measure Information:
Title
Blood Pressure
Description
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.
Time Frame
Baseline, 3 months, 6 months
Secondary Outcome Measure Information:
Title
Hair Cortisol
Description
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.
Time Frame
Baseline, 6 months
Title
Newest Vital Sign
Description
Measure of health literacy. Scores range from 0-6 with lower scores indicating lower health literacy
Time Frame
Baseline
Title
Stress Management Practices survey part A
Description
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.
Time Frame
Baseline, 3 months, 6 months
Title
Pittsburgh Stress Battery
Description
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.
Time Frame
Baseline, 3 months, 6 months
Title
Block food frequency questionnaire
Description
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
Time Frame
Baseline, 3 months, 6 months
Title
Daily inventory of stressful events
Description
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.
Time Frame
Baseline, 3 months, 6 months
Title
Perceived stress scale (caregiver stress)
Description
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.
Time Frame
Baseline, 3 months, 6 months
Title
World Health Organization Quality of Life (WHO-5 QOL)
Description
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
Time Frame
Baseline, 3 months, 6 months
Title
Depression Anxiety Stress Symptom Scale (DASS-21)
Description
Assess psychological comorbidity of the caregiver and health status of the person living with ADRD. Contains 21 items to evaluate mild, moderate, or severe depression, anxiety, and stress (α =0.79). Scores range from 0-37 with higher scores indicating more symptoms.
Time Frame
Baseline, 3 months, 6 months
Title
Revised Memory and Behavior Checklist
Description
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
Time Frame
Baseline, 3 months, 6 months
Title
Credibility Scale
Description
The Credibility Scale (α = 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.
Time Frame
3 months
Title
Acceptability Scale
Description
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.
Time Frame
3 months
Title
Krousel-Wood Medication Adherence Scale
Description
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.
Time Frame
Baseline, 3 months, 6 months
Title
Behavioral Risk Factor Surveillance System-physical activity (BRFSS)
Description
BRFSS is used to track health conditions and risk behaviors, with this module tracking physical activity
Time Frame
Baseline, 3 months, 6 months
Title
Diet History Questionnaire (DHQ) III
Description
DHQ is a food frequency questionnaire for use with adults 19 or more years of age to assess food and dietary supplement intakes.
Time Frame
Baseline, 3 months, 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kathy Wright, PhD
Phone
614-292-0309
Email
wright.2104@osu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra Solove, MA
Phone
614
Email
solove.3@osu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathy Wright, PhD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathy Wright, PhD
Phone
614-292-0309
Email
wright.2104@osu.edu
First Name & Middle Initial & Last Name & Degree
Sandra Solove, MA
Email
solove.3@osu.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be disseminated using multiple strategies, such as making our results available to the NIH ClinicalTrials.gov website, transmitting them to the aging research community through peer-reviewed journals, and giving presentations of the results of the study at national and international scientific meetings. Additionally, presentations will be given to the local African American community to churches, Alzheimer's disease support groups, and beauty salons.
IPD Sharing Time Frame
Data will be available 01/01/2027 until 0101/2027
IPD Sharing Access Criteria
To access data, inquires will go to Kathy Wright, PhD, RN at wright.2104@osu.edu

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Stress and Blood Pressure Management for Caregivers

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