Ignite Creation Date:
2024-05-06 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05734638
Status:
RECRUITING
Last Update Posted:
2023-09-28
First Post:
2022-11-10
Brief Title:
Stress and Blood Pressure Management for Caregivers
Sponsor:
Ohio State University
Organization:
Ohio State University
Study Overview
Official Title:
Self-Care and Blood Pressure for Women Caregivers of Black and African-Americans With Alzheimers Disease or Other Memory Problems
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
StressHTN
Brief Summary:
Due to health and wealth disparities no demographic group is more at risk than African American women for the double jeopardy of stress from caregiving for persons living with dementia PLWD and stress associated with hypertension HTN This double jeopardy puts those they care for in jeopardy as well Reduced quality of life and longevity disability cognitive decline and stroke associated with HTN1 impede caregiving activities and resultant health and well-being for persons living with Alzheimers disease and related dementias ADRD Although successful multi-component interventions have addressed ADRD caregiver stress REACH II and the Savvy Caregiver program to our knowledge there are no interventions that target the complexity of chronic caregiving stress and HTN self-care for African American women caregivers of persons living with ADRD
This project will test two interventions for their effectiveness in improving outcomes for the target group Mindfulness in Motion MIM and the Dietary Approaches to Stop Hypertension DASH MIM includes mindful awareness and movement from a seated position breathing exercises healthy sleep and guided mindfulness meditation The DASH component will be tailored for Black Americans It uses a critical thinking approach that involves problem solving participant-centered goal setting health coaching reflection and development of self-efficacy confidence to promote physical activity and healthy eating Solid empirical evidence demonstrates its effectiveness in reducing blood pressure among mixed-race samples
This project will test two interventions for their effectiveness in improving outcomes for the target group Mindfulness in Motion MIM and the Dietary Approaches to Stop Hypertension DASH MIM includes mindful awareness and movement from a seated position breathing exercises healthy sleep and guided mindfulness meditation The DASH component will be tailored for Black Americans It uses a critical thinking approach that involves problem solving participant-centered goal setting health coaching reflection and development of self-efficacy confidence to promote physical activity and healthy eating Solid empirical evidence demonstrates its effectiveness in reducing blood pressure among mixed-race samples
Detailed Description:
Our long-term goal is to develop effective interventions to reduce cardiovascular health disparities and improve health outcomes among African American women Given this gap in knowledge ie interventions targeting caregiving stress and hypertension self-care our Stage I pilot study focuses on a caregiver stress and b self-care for hypertension the most prevalent chronic condition among African American women caregivers of PLWD We know lifestyle changes are effective in managing HTN but they will not make a difference in controlling hypertension if individuals do not engage in these health behaviors Unfortunately African American women are less likely to engage in self-care such as diet and exercise behaviors if they believe their hypertension is caused by stress Indeed our past research demonstrates that stressful interpersonal communication problems blood pressure knowledge deficits and complex diet information all interfered with older African American womens blood pressure self-care Thus we investigate the hypothesis that by addressing stress reactivitystress resilience as the underlying mechanism to facilitate behavioral change the intervention will be successful in enhancing HTN self-care
A small-scale Stage I three-group randomized controlled trial RCT will investigate the feasibility of MIM plus DASH to improve blood pressure self-care in African American caregivers as compared to MIM only or DASH only Each intervention will be delivered in eight weekly 1-hour group sessions via telehealth
To our knowledge this is the first study that systematically a examines impact on self-care behaviors and b employs one of the Science of Behavioral Change key mechanisms underlying successful change in health behaviors-stress reactivitystress resilience among a large underrepresented demographic group PI Wright will recruit 90 women with hypertension who are caring for persons living with ADRD 30 per group MIM DASH MIM only or DASH only We will collect data at baseline 3-months and 6-months The interprofessional team pursuing this project has worked together for 3 years Our aims will be as follows
AIM 1 Determine the feasibility of MIM DASH MIM and DASH for African American women caregivers of familyfriends living with dementia Hypothesis African American women caregivers with hypertension will participate in the MIM DASH as well as the active control groups MIM or DASH
Aim 2 Examine pilot efficacy of the MIM DASH intervention to improve stress and self-care as compared to active control groups MIM or DASH Hypothesis Stress will be reduced and self-care will be improved in the MIM DASH group as compared to active control groups MIM or DASH
AIM 3 Examine the pilot efficacy of the combination of MIM plus DASH for improvement of systolic blood pressure SBP as compared to active control groups MIM or DASH Hypothesis Relative to baseline assessment the MIM DASH group will exhibit lower SBP at 3 and 6 months as compared to active control groups MIM or DASH
A small-scale Stage I three-group randomized controlled trial RCT will investigate the feasibility of MIM plus DASH to improve blood pressure self-care in African American caregivers as compared to MIM only or DASH only Each intervention will be delivered in eight weekly 1-hour group sessions via telehealth
To our knowledge this is the first study that systematically a examines impact on self-care behaviors and b employs one of the Science of Behavioral Change key mechanisms underlying successful change in health behaviors-stress reactivitystress resilience among a large underrepresented demographic group PI Wright will recruit 90 women with hypertension who are caring for persons living with ADRD 30 per group MIM DASH MIM only or DASH only We will collect data at baseline 3-months and 6-months The interprofessional team pursuing this project has worked together for 3 years Our aims will be as follows
AIM 1 Determine the feasibility of MIM DASH MIM and DASH for African American women caregivers of familyfriends living with dementia Hypothesis African American women caregivers with hypertension will participate in the MIM DASH as well as the active control groups MIM or DASH
Aim 2 Examine pilot efficacy of the MIM DASH intervention to improve stress and self-care as compared to active control groups MIM or DASH Hypothesis Stress will be reduced and self-care will be improved in the MIM DASH group as compared to active control groups MIM or DASH
AIM 3 Examine the pilot efficacy of the combination of MIM plus DASH for improvement of systolic blood pressure SBP as compared to active control groups MIM or DASH Hypothesis Relative to baseline assessment the MIM DASH group will exhibit lower SBP at 3 and 6 months as compared to active control groups MIM or DASH
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None