- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06451250
Providing Evidence-Based Approaches for Caregiver Stress Study (PEACE)
December 23, 2025 updated by: Johns Hopkins Bloomberg School of Public Health
Providing Evidence-Based Approaches for Caregiver Stress (PEACE) Study
The purpose of this preliminary study is to examine the effects of adult day service use on subjective and physiological measures of stress in 50 Black informal caregivers for individuals with dementia (IWD).
The PI of the proposed study has substantial training in primary data collection and complex-survey secondary data analysis, she also has the fundamental knowledge to investigate how sociocultural and behavioral factors can influence psychosocial stress.
The proposed study will enroll participants from adult day service (ADS) nationally, to examine the effects of adult day service use on subjective and physiological measures of stress in 50 Black informal caregivers.
The proposed study extends the current science on the use of ADS on subjective and physiological stress by 1) examining differential impacts of ADS specifically on subjective measures of stress for Black caregivers, 2) evaluating the impact of ADS use on physiological measures of stress among Black caregivers; and 3) examining the relationship between subjective indicators and physiological processes for Black caregivers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21205
- Johns Hopkins University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Study Population
Black/African American caregivers for a person living with dementia who utilizes adult day services at least twice a week
Description
Inclusion Criteria:
- 18 years or older (male or female)
- Self-identify as Black and/or African American,
- Lives with a family member with a physician diagnosis of Alzheimer's disease or related dementia
- Primary responsibility for care of the family member who has been diagnosed with Alzheimer's disease or related dementia
- Utilize Adult Day Services at least two times a week for family member with Alzheimer's disease or related dementia
Exclusion Criteria:
- Either caregiver of client is in active treatment for a terminal illness or are in hospice.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Adult Day Services
Adult Day Service use for family member with dementia
|
Self-collection of salivary biomarkers 4 times daily for 5 days, two of those days the family member with dementia has to use adult day services
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Caregiver stress as assessed by the Perceived Stress Scale
Time Frame: Baseline
|
Perceived Stress Scale scores range from 0 to 40 with higher scores indicating higher perceived stress
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Salivary cortisol levels
Time Frame: Over a five day period
|
Saliva will be collected into sterile collection tubes and stored in participants' freezers until sampling.
the test volume will be 25 µL with a sensitivity range of 0.007-3.0
µL/dl.
|
Over a five day period
|
|
Salivary alpha-amylase
Time Frame: Over a five day period
|
Saliva will be collected into sterile collection tubes and stored in participants' freezers until sampling.
the test volume will be 10 µL with a sensitivity range of 0.4-400 U/mL.
|
Over a five day period
|
|
Salivary Telomere length
Time Frame: Over a five day period
|
Saliva will be collected into sterile collection tubes and stored in participants' freezers until sampling.
the test volume will be 2ml
|
Over a five day period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Lauren Parker, PhD, MPH, Johns Hopkins Bloomberg School of Public Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 2, 2024
Primary Completion (Actual)
December 19, 2025
Study Completion (Actual)
December 19, 2025
Study Registration Dates
First Submitted
June 5, 2024
First Submitted That Met QC Criteria
June 5, 2024
First Posted (Actual)
June 11, 2024
Study Record Updates
Last Update Posted (Actual)
December 24, 2025
Last Update Submitted That Met QC Criteria
December 23, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00008919
- 1K01AG066812-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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