Providing Evidence-Based Approaches for Caregiver Stress Study

Dementia Clinical Trial

— PEACE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06451250
• Other study ID #: IRB00008919
• Secondary ID: 1K01AG066812-01
• Status: Recruiting
• Start date: February 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: Lauren Parker, PhD, MPH
• Phone: ?(443) 885-0957?
• Email: peacestudy[@]jhu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2025
• Est. primary completion date: May 1, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dementia

Intervention

Other:
• 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

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Salivary cortisol levels	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
Secondary	Salivary alpha-amylase	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
Secondary	Salivary Telomere length	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