Stress and Blood Pressure Management for Caregivers

NCT05734638 | Active Not Recruiting DMC

• 1 other identifier: 2022B0064
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Stress, Psychological

Keywords

Dementia Caregivers

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 3 months, 6 months

Secondary Outcomes (11)

• Hair Cortisol

  Baseline, 6 months

• Block food frequency questionnaire

  Baseline, 3 months, 6 months

• Daily inventory of stressful events

  Baseline, 3 months, 6 months

• Perceived stress scale (caregiver stress)

  Baseline, 3 months, 6 months

• Depression Anxiety Stress Symptom Scale (DASS-21)

  Baseline, 3 months, 6 months

Study Arms (3)

MIM-DASH

EXPERIMENTAL

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).

Behavioral: MIM-DASH

MIM Only

EXPERIMENTAL

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.

Behavioral: MIM Only

DASH Only

EXPERIMENTAL

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.

Behavioral: DASH Only

Interventions

MIM-DASH BEHAVIORAL

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.

MIM-DASH

MIM Only BEHAVIORAL

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.

MIM Only

DASH Only BEHAVIORAL

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.

DASH Only

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Ohio State University: lead
• Robert Wood Johnson Foundation: collaborator

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Hypertension; Stress, Psychological

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior

Study Officials

• Kathy Wright, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized control trial of behavioral intervention

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: February 21, 2023
• Study Start: September 11, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available 01/01/2027 until 0101/2027
• Access Criteria: To access data, inquires will go to Kathy Wright, PhD, RN at wright.2104@osu.edu

Locations

US (1)