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

28 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

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 data supports the effectiveness of the treatment Caregiver Training for stress and high blood pressure in dementia caregivers?

Research shows that psychosocial interventions, including mindfulness and exercise, can reduce stress and improve well-being in dementia caregivers. Mindfulness has been found to help lower blood pressure by reducing stress, and exercise interventions have shown to decrease perceived stress and increase self-efficacy in caregivers. ^{1 2 3 4 5}

Is the lifestyle change treatment for stress and high blood pressure in dementia caregivers safe?

Research on similar interventions, like mindfulness and exercise programs for dementia caregivers, suggests they are generally safe and may help reduce stress and improve health. These studies did not report any significant safety concerns. ^{1 3 4 6 7}

How does the Caregiver Training treatment differ from other treatments for stress and high blood pressure in dementia caregivers?

Caregiver Training is unique because it focuses on lifestyle changes, such as mindfulness and physical activity, to help reduce stress and manage blood pressure in dementia caregivers. Unlike standard medical treatments, this approach emphasizes psychological resources and self-care practices to improve caregivers' cardiovascular health. ^{3 4 7 8 9}

Research Team

Kathy Wright, PhD

Principal Investigator

Ohio State University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of Psychosocial Interventions and Caregiving Stress on Cardiovascular Biomarkers in Family Dementia Caregivers: The UCSD Pleasant Events Program (PEP) Randomized Controlled Trial. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Systematic review of dyadic psychoeducational programs for persons with dementia and their family caregivers. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Stress and Blood Pressure in Dementia Caregivers: The Moderator Role of Mindfulness. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

The effectiveness of nonpharmacological interventions for informal dementia caregivers: An updated systematic review and meta-analysis. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Effects of leisure activities at home on perceived care burden and the endocrine system of caregivers of dementia patients: a randomized controlled study. [2016]

7. England pubmed.ncbi.nlm.nih.gov

Accelerated risk of hypertensive blood pressure recordings among Alzheimer caregivers. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Regular physical activity moderates cardiometabolic risk in Alzheimer's caregivers. [2021]

9. United States 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. [2023]