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Completed

NCT Number: NCT06451250

Providing Evidence-Based Approaches for Caregiver Stress 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adult Day Service use for family member with dementia

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: PEACE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 11, 2024
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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