NCT06451250

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 11, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2025

Completed
Last Updated

December 24, 2025

Status Verified

December 1, 2025

Enrollment Period

1.9 years

First QC Date

June 5, 2024

Last Update Submit

December 23, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Caregiver stress as assessed by the Perceived Stress Scale

    Perceived Stress Scale scores range from 0 to 40 with higher scores indicating higher perceived stress

    Baseline

Secondary Outcomes (3)

  • Salivary cortisol levels

    Over a five day period

  • Salivary alpha-amylase

    Over a five day period

  • Salivary Telomere length

    Over a five day period

Study Arms (1)

Adult Day Services

EXPERIMENTAL

Adult Day Service use for family member with dementia

Other: Adult Day Service use for family member with dementia

Interventions

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

Adult Day Services

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Either caregiver of client is in active treatment for a terminal illness or are in hospice.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Caregiver BurdenDementia

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Lauren Parker, PhD, MPH

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2024

First Posted

June 11, 2024

Study Start

February 2, 2024

Primary Completion

December 19, 2025

Study Completion

December 19, 2025

Last Updated

December 24, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations