Caregiving StressPEACENCT06451250
Providing Evidence-Based Approaches for Caregiver Stress Study
A study testing Adult Day Service use for family member with dementia in people with Caregiving Stress and Dementia, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregiving Stress, Dementia
- What is being tested?
- Adult Day Service use for family member with dementia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2024to 19 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Either caregiver of client is in active treatment for a terminal illness or are in hospice.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Caregiving Stress, Dementia
- Being tested
- Adult Day Service use for family member with dementia
- Medical subject headings
- Caregiver Burden, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adult Day Service use for family member with dementiaOther
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
| Study group | Role | What they receive |
|---|---|---|
| Adult Day Services | Experimental | Adult Day Service use for family member with dementia Receives: Other: Adult Day Service use for family member with dementia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (3)
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.
Measured: Over a five day period
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.
Measured: Over a five day period
Salivary Telomere length
Saliva will be collected into sterile collection tubes and stored in participants' freezers until sampling. the test volume will be 2ml
Measured: Over a five day period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start2 Feb 2024
- Primary completion19 Dec 2025
- Study completion19 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiving StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Lauren Parker, PhD, MPH, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451250
- Sponsor's protocol ID
- IRB00008919
- Other IDs
- 1K01AG066812-01
- Acronym
- PEACE
- Status last verified
- Dec 2025
- First submitted
- 5 Jun 2024
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Providing Evidence-Based Approaches for Caregiver Stress (PEACE) Study
- ClinicalTrials.gov ID
- NCT06451250
- Acronym / sponsor ID
- PEACE / IRB00008919
- Conditions
- Caregiving Stress, Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 19 Dec 2025 (actual)
- Study completion
- 19 Dec 2025 (actual)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult Day Services | Experimental | Other: Adult Day Service use for family member with dementiaAdult Day Service use for family member with dementia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Either caregiver of client is in active treatment for a terminal illness or are in hospice.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adult Day Service use for family member with dementiaSelf-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 | Other | Adult Day Services |
Primary outcome
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
3 secondary outcomes
Salivary cortisol levels
Time frame: Over a five day period
Salivary alpha-amylase
Time frame: Over a five day period
Salivary Telomere length
Time frame: Over a five day period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren Parker, PhD, MPH principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adult Day Service use for family member with dementia in people with Caregiving Stress and Dementia, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver stress as assessed by the Perceived Stress Scale (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.