Stress and Hypertension in Dementia Caregivers

NCT05721482 | Completed Results DMC

• 2 other identifiers: 2022B0031R21AG077069
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Hypertension; Stress, Psychological

Keywords

Dementia Caregivers

Outcome Measures

Primary Outcomes (3)

• Change in Blood Pressure (Systolic)

  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.

  Baseline, 3 months, 9 months

• Change in Blood Pressure (Diastolic)

  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.

  Baseline, 3 month, 9 month

• Change in Heart Rate

  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.

  Baseline, 3 month, 9 month

Secondary Outcomes (10)

• 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 Perceived Stress Scale (Caregiver Stress)

  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 Generalized Anxiety Symptom Scale

  Baseline, 3 months, 9 months

Study Arms (2)

MIM-DASH

EXPERIMENTAL

A trained MIM provider and dietitian will deliver the MIM DASH group intervention in eight weekly 1-hour sessions via telehealth.

Behavioral: Caregiver Training

Attention Control

NO INTERVENTION

A trained interventionist will deliver the Caregiver Training. Participants in this group will attend eight 1-hour group lessons via telehealth for 8 weeks. We will use Alzheimer's Association caregiver training resources on topics such as Healthy Living for Your Brain and Body: Tips from the Latest Research; Dementia Conversations: Driving, Doctors Visits, Legal and Financial Planning; and Understanding and Responding to Dementia-Related Behavior. Similar to the MIM DASH group, participants will receive educational materials so they can follow along using videoconferencing or phone.

Interventions

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.

Also known as: MIM-DASH

MIM-DASH

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

College of Nursing Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• Wright KD, Richards Adams IK, Helsabeck NP, Rose KM, Moss KO, Nemati D, Palmer N, Kim B, Pokhrel Bhattarai S, Nguyen C, Addison D, Klatt MD. Stress and Hypertension Among African American Female Family Caregivers of Persons Living With Alzheimer Disease and Related Dementias: Protocol for a Pilot Internet-Based Randomized Controlled Trial. JMIR Res Protoc. 2025 Mar 27;14:e66975. doi: 10.2196/66975.

  PMID: 40146982 DERIVED

MeSH Terms

Conditions

Hypertension; Stress, Psychological

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Kathy Wright
• Organization: The Ohio State University College of Nursing

wright.2104@osu.edu

614-292-0309

Study Officials

• Kathy Wright, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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 10, 2023
• Study Start: January 17, 2023
• Primary Completion: September 15, 2024
• Study Completion: September 2, 2025
• Last Updated: September 17, 2025
• Results First Posted: February 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Individual participant data will not be shared due to the regulation not pertaining to this grant
• Access Criteria: Individual participant data will not be shared due to the regulation not pertaining to this grant

Locations

US (1)