Lifestyle Changes for Stress and High Blood Pressure in Dementia Caregivers

(MIM-DASH Trial)

Overseen By Sandra Solove, MA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Ohio State University

Must be taking: Antihypertensives

Disqualifiers: Resistant hypertension, Active mindfulness/yoga, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist African American women who care for family members with Alzheimer's and have high blood pressure (hypertension). The study examines how lifestyle changes, such as stress management, increased consumption of fruits and vegetables, and regular exercise, can improve health outcomes. Participants will attend eight weekly sessions via telehealth to learn stress and diet management through caregiver training. Women who self-identify as Black or African American, provide unpaid care for someone with dementia for at least 10 hours a week, and take medication for high blood pressure may be suitable candidates. As an unphased trial, this study offers a unique opportunity to explore lifestyle changes that could enhance well-being and the caregiving experience.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since it includes participants who are already on antihypertensive medication, it seems likely that you can continue your current treatment.

What prior data suggests that these lifestyle changes are safe for managing stress and high blood pressure in dementia caregivers?

Research shows that the MIM-DASH program is practical and well-received by African Americans with high blood pressure and mild memory issues. Earlier studies have shown that this program holds promise in reducing stress and enhancing the quality of life for caregivers. Participants generally handled the treatment well, with no major side effects reported. This suggests the program is safe, particularly for those managing stress and high blood pressure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores unique lifestyle interventions for managing stress and high blood pressure among dementia caregivers. Unlike standard medication-based treatments, this trial emphasizes non-pharmacological approaches, such as the MIM-DASH program, which combines dietary guidance and stress management techniques delivered through convenient telehealth sessions. This approach not only aims to improve caregivers' physical health but also their mental well-being, offering a holistic alternative to traditional care. By focusing on caregiver training and support, researchers hope to uncover effective methods to alleviate the burdens faced by those caring for loved ones with dementia.

What evidence suggests that this trial's treatments could be effective for stress and high blood pressure in dementia caregivers?

Research has shown that lifestyle changes such as managing stress, reducing salt intake, eating more fruits and vegetables, and exercising regularly can help control high blood pressure. In this trial, participants may join the MIM-DASH program, which includes these changes and has proven helpful for African American women caring for family members with dementia. This program emphasizes building stress resilience—the body's ability to cope with stress—to reduce stress and improve heart health. Evidence supports that the DASH diet can lower blood pressure, making it a key component of this program. Overall, the MIM-DASH program appears promising for improving health in this group. Another group in this trial will receive Caregiver Training using Alzheimer's Association resources, focusing on topics like healthy living and dementia-related behavior. ^{1 2 5 6 7}

Who Is on the Research Team?

Kathy Wright, PhD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for African American women over 40 who care unpaid for a family member with Alzheimer's or related dementias, work at least 10 hours per week in caregiving, have high blood pressure treated with medication, and can access the internet. It excludes those planning to move soon, with resistant hypertension, or actively doing mindfulness/yoga.

Inclusion Criteria

Access to a telecommunications device such as the internet via desktop, laptop/tablet, smartphone, or telephone

English speaking

I am 40 years old or older.

Exclusion Criteria

My high blood pressure doesn't improve despite taking three different medications including a water pill.

I am actively participating in a mindfulness or yoga program.

Expect to move out of the area within 9 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the MIM DASH intervention or Caregiver Training in 8 weekly 1-hour group sessions via telehealth

8 weeks

8 visits (virtual)

Follow-up

Participants receive bi-monthly coaching calls after completion of the 8-week intervention

2 months

4 calls (virtual)

Long-term Follow-up

Participants are monitored for changes in blood pressure, stress management practices, and quality of life

9 months

What Are the Treatments Tested in This Trial?

Interventions

• Caregiver Training

Trial Overview

The study tests caregiver training aimed at managing stress and hypertension through lifestyle changes like diet adjustments and physical activity. The goal is to improve caregivers' quality of life and reduce cardiovascular disease risk by enhancing their stress resilience.

How Is the Trial Designed?

Group I: MIM-DASH Experimental Treatment 1 Intervention

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

Group II: Attention Control Active Control 1 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.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

A systematic review of 24 studies on dyadic psychoeducational support programs for people with dementia and their caregivers found that tailored, goal-oriented programs significantly improve various aspects of health and quality of life for both parties.

The review highlights the importance of long-term, individualized support programs to address the progressive needs of individuals with dementia and their caregivers, suggesting that such interventions can lead to sustained positive outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of dyadic psychoeducational programs for persons with dementia and their family caregivers. Ghosh, M., Dunham, M., O'Connell, B.[2023]

The dyadic intervention combining mindfulness-based stress reduction (MBSR) for caregivers and balance and progressive resistance training (PRT) for their loved ones significantly improved caregiver mindfulness and functional mobility in the loved ones, indicating potential benefits for both parties involved.

Despite these improvements, the intervention did not significantly reduce caregiver burden, suggesting that while mindfulness training is beneficial, additional strategies may be needed to address the challenges faced by caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caring for Informal Dementia Caregivers and Their Loved Ones Via the HOMeCARE Exercise and Mindfulness for Health Program (HOMeCARE): A Randomized, Single-Blind, Controlled Trial. Lang, T., Daniel, K., Inskip, M., et al.[2023]

A telephone-based exercise intervention for 137 women caring for spouses with dementia led to significant increases in physical activity and reductions in perceived stress after six months, especially among those who initially exercised less.

Participants in the intervention group also reported greater improvements in exercise self-efficacy compared to the control group, suggesting that focusing on exercise can enhance self-care for dementia caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Telephone-Based Exercise Intervention for Dementia Caregiving Wives: A Randomized Controlled Trial. Connell, CM., Janevic, MR.[2022]

Citations

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Stress and Hypertension Among African American Female ...

Conclusions: This study's findings demonstrate the feasibility of conducting an internet-based intervention (MIM DASH) for African American ...

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cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/82/NCT05721482/Prot_SAP_000.pdf

Stress and Hypertension in Dementia Caregivers (MIM- ...

Solid empirical evidence demonstrating the effectiveness of the DASH diet in reducing blood pressure. ... outcomes—caregiver stress and HTN; and 3 ...

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clinicaltrial.be

clinicaltrial.be/en/details/191617?per_page=100&only_recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&completed=0&only_eligible=0&only_active=0

Stress and Hypertension in Dementia Caregivers

Randomized participants will receive the MIM DASH or Caregiver Training in 8 weekly 1-hour group sessions via telehealth. Both groups will ...

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ctv.veeva.com

ctv.veeva.com/study/stress-and-hypertension-in-dementia-caregivers

Stress and Hypertension in Dementia Caregivers (MIM-DASH)

Both situations lead to reduced quality of life and cardiovascular disease-a complication of uncontrolled hypertension. Maintaining the health ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8329944/

Mindfulness in Motion and Dietary Approaches to Stop ...

CONCLUSION: Results indicate that the MIM DASH intervention was feasible and culturally acceptable in African Americans with hypertension and MCI.

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11986388/

Stress and Hypertension Among African American Female ...

This study aims (1) to determine the feasibility and acceptability of MIM DASH and caregiver training for African American female caregivers with hypertension; ...

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alz-journals.onlinelibrary.wiley.com

alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.073841

Stress and hypertension self‐care pilot study for Black women ...

Result. MIM DASH will be feasible and acceptable, and will decrease caregivers' stress and improve quality of life; higher stress resilience ...