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Lifestyle Changes for Stress and High Blood Pressure in Dementia Caregivers (MIM-DASH Trial)
N/A
Recruiting
Led By Kathy Wright, PhD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 40 and older
Caregiver provides unpaid care to a PLWD at least 10 hours per week or assists with at least one instrumental activity of daily living
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 9 months
Awards & highlights
MIM-DASH Trial Summary
This trial is looking at how lifestyle changes like stress management, reducing sodium, eating fruits/veggies, and physical activity can help African American women caregivers reduce caregiving stress and hypertension. Improving lifestyle can lead to better health outcomes.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this intervention involves non-medical lifestyle changes and education rather than drugs or medical procedures, side effects are minimal but may include discomfort from new activities or dietary changes.
MIM-DASH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 40 years old or older.
Select...
I provide unpaid care for someone with dementia for 10+ hours a week or help them with daily tasks.
Select...
I have high blood pressure and am taking medication for it.
MIM-DASH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 months, 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 9 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Blood Pressure
Secondary outcome measures
Acceptability Scale
Change in depression will be assessed in the PHQ-9
Change is being assessed in Daily inventory of stressful events
+11 moreMIM-DASH Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: MIM-DASHExperimental Treatment1 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 ControlActive Control1 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.
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Who is running the clinical trial?
Ohio State UniversityLead Sponsor
837 Previous Clinical Trials
507,918 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,692 Previous Clinical Trials
28,027,186 Total Patients Enrolled
Kathy Wright, PhDPrincipal InvestigatorOhio State University
1 Previous Clinical Trials
90 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 40 years old or older.I provide unpaid care for someone with dementia for 10+ hours a week or help them with daily tasks.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.A caregiver rates the person with Alzheimer's with a score of 2 or more on the Alzheimer's Dementia-8 scale.I have high blood pressure and am taking medication for it.
Research Study Groups:
This trial has the following groups:- Group 1: MIM-DASH
- Group 2: Attention Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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