Providing Evidence-Based Approaches for Caregiver Stress Study (PEACE)

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

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.

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

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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