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Stress and Blood Pressure Management for Caregivers (Stress/HTN 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months, 6 months

Awards & highlights

Stress/HTN Trial Summary

This trial seeks to reduce stress & hypertension for African-American women caregivers of dementia patients, using mindfulness & DASH tailored for Black Americans.

Who is the study for?

This trial is for African American women over 40 who care unpaid for someone with dementia at least 10 hours a week, have high blood pressure treated with medication, and can use the internet or phone. They must speak English and rate the person they're caring for as needing significant help. Those already doing mindfulness or yoga, or with resistant high blood pressure aren't eligible.Check my eligibility

What is being tested?

The study tests two interventions: Mindfulness in Motion (MIM) which includes seated movement and meditation exercises; and DASH diet tailored to Black Americans focusing on healthy eating and physical activity. The goal is to see if these reduce caregiver stress and improve blood pressure control.See study design

What are the potential side effects?

There are generally no severe side effects expected from MIM or DASH diet interventions. Participants might experience mild discomfort when starting new exercise routines or changing dietary habits.

Stress/HTN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Blood Pressure

Secondary outcome measures

Acceptability Scale

Behavioral Risk Factor Surveillance System-physical activity (BRFSS)

Block food frequency questionnaire

+12 more

Stress/HTN Trial Design

3Treatment groups

Experimental Treatment

Group I: MIM-DASHExperimental Treatment1 Intervention

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).

Group II: MIM OnlyExperimental Treatment1 Intervention

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.

Group III: DASH OnlyExperimental Treatment1 Intervention

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Ohio State UniversityLead Sponsor

830 Previous Clinical Trials

505,530 Total Patients Enrolled

Robert Wood Johnson FoundationOTHER

157 Previous Clinical Trials

686,744 Total Patients Enrolled

Kathy Wright, PhDPrincipal InvestigatorOhio State University

1 Previous Clinical Trials

28 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings available for individuals to participate in this investigation?

"Affirmative. According to information hosted on clinicaltrials.gov, recruitment for this medical study began on September 11th 2023 and was last updated in late September of the same year. This research is actively seeking 90 participants from one medical centre."

Answered by AI

What is the aggregate number of participants in this medical experiment?

"Confirmed. Information hosted on clinicaltrials.gov reveals that this research study, which was initially advertised on September 11th 2023, is actively recruiting participants. Approximately 90 patients must be enrolled from 1 site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Stress and Blood Pressure Management for Caregivers

Kathy D. Wright 2023. "Stress and Blood Pressure Management for Caregivers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05734638.