N/A
N=28
Stress and Hypertension in Dementia Caregivers
Hypertension · Stress, Psychological
Bottom Line
View on ClinicalTrials.gov: NCT05721482 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Change in Blood Pressure (Systolic) — 129; 127; 122; 124 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Caregiver Training (Behavioral)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Ohio State University
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Blood Pressure (Systolic) |
129; 127; 122; 124; 132; 122 | — |
| PRIMARY Change in Blood Pressure (Diastolic) |
77; 82; 72; 76; 80; 76 | — |
| PRIMARY Change in Heart Rate |
73; 71; 77; 71; 70; 73 | — |
| SECONDARY Newest Vital Sign |
4.23; 3.92 | — |
| SECONDARY Change is Being Assessed in Stress Management Practices Survey Part A |
34.54; 40.46; 39.31; 38.2; 35.93; 35.92 | — |
| SECONDARY Change is Being Assessed in Perceived Stress Scale (Caregiver Stress) |
14.93; 14.57; 14.92; 10.78; 12.57; 10.75 | — |
| SECONDARY Change is Being Assessed in in World Health Organization Quality of Life (WHO-5 QOL) |
13.79; 16.83; 13.83; 17.67; 15.14; 16.2 | — |
| SECONDARY Change is Being Assessed in Generalized Anxiety Symptom Scale |
5.64; 3.29; 4.46; 3.8; 3.5; 2.33 | — |
| SECONDARY Change is Being Assessed in Revised Memory and Behavior Checklist |
20.57; 15.92; 18.58; 15.5; 14; 16.3 | — |
| SECONDARY Credibility Scale |
41.23; 41.42 | — |
| SECONDARY Acceptability Scale |
59.08; 60.83 | — |
| SECONDARY Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4) |
1.214; 1.077; 1.167; 1; 0.929; 1.091 | — |
| SECONDARY Patient Health Questionnaire (PHQ-9) |
4.86; 3.69; 6.23; 3.9; 3.62; 3.42 | — |
Summary
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).
Eligibility Criteria
Inclusion criteria
- diagnosis of Hypertension (HTN) treated with an antihypertensive medication;
- age 40 and older
- a caregiver rating of the People Living With Dementia (PLWD) of 2 or greater on the Alzheimer's Dementia-8 scale;
- caregiver provides unpaid care to a PLWD at least 10 hours per week or assists with at least one instrumental activity of daily living
- self-identifies as Black/African American;
- English speaking; and
- access to a telecommunications device such as the internet via desktop, laptop/tablet, smartphone, or telephone.
Exclusion criteria
- expect to move out of the area within 9 months;
- diagnosis of resistant HTN (blood pressure that remains above goal despite concurrent use of a diuretic/water pill and at least two other antihypertensive agents of different classes); or
- active participation in mindfulness/yoga program. The National Institute of Aging Common Data Screening and Enrollment forms will be used to track data.
Data sourced from ClinicalTrials.gov (NCT05721482). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.