Stress, PsychologicalNCT04856462
The Alzheimer's Companion Engagement (ACE) Project.
A study testing Education Support in people with Stress, Psychological and Adaptation, Psychological, run by University of Michigan at 1 site in United States.
Trial summary
Black family caregivers of older adults with Alzheimer's disease and/or related dementias (ADRD), have an increased mortality risk related to pre-existing health conditions and stress. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Adaptation, Psychological
- What is being tested?
- Education Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2025to 22 Oct 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-identified as Black/ African American At least 18 years old Able to speak, understand, and hear spoken English Related to, or has a close personal relationship to a person over the age of 55 that has an ADRD diagnosis or evidence of cognitive impairment Regular access to a smartphone, tablet or computer with internet access that will allow video conferencing engagement.
- Provides monitoring, and assistance in activities of daily living and or other care tasks for the care recipient.
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Black family caregivers of older adults with Alzheimer's disease and/or related dementias (ADRD), have an increased mortality risk related to pre-existing health conditions and stress. Targeted, culturally responsive, health interventions that help Black ADRD caregivers to effectively manage their own health and use community preferenced ways of coping, can improve caregivers' overall health, perceived ability to provide care for a person with ADRD (self-efficacy), and increases the likelihood that they will experience benefits from caregiving. This clinical trial pilot will test the feasibility of a community based intervention designed to improve health outcomes for Black family caregivers of persons with ADRD.
Read the detailed description
The proposed intervention is a peer-supportive and facilitator-led video teleconference program that will engage small groups of caregivers weekly over 6 weeks. Each week participants (n = 36, 2-5/group) will receive a different culturally relevant caregiving or personal health strategy to practice. During the support calls, a facilitator will provide an overview of the content covered and each participant will have the opportunity to discuss their past week and how they engaged the weekly strategy, or challenges that came up for them during the week. The format will be structured to ensure that core content is reviewed, and everyone can be equally engaged while flexible enough that caregivers can receive support in the areas they need. A battery of assessment measures will be taken at weeks 1 and 8.
- Conditions
- Stress, Psychological, Adaptation, Psychological
- Being tested
- Education Support
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education SupportBehavioural
Caregivers engage in a weekly video/teleconference support group with a skilled facilitator to discuss various strategies for managing caregiving stress, challenging behaviors, and personal self-care.
| Study group | Role | What they receive |
|---|---|---|
| Caregiver Support | Experimental | All participants in all groups will receive 6 weeks of caregiving support including a weekly video/teleconference call, and handouts covering relevant educational topics) Receives: Behavioral: Education Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver Self-efficacy
Caregiver self-efficacy will be measured by the Revised Scale for Caregiving Self-Efficacy, which evaluates the caregivers' ability to obtain respite care, respond to disruptive behaviors, and control one's own upsetting thoughts about caregiving.
Measured: 6 weeks
Secondary outcomes (1)
Positive Aspects of Caregiving
Positive Aspects of Caregiving will be an additional outcome measure. The Positive Aspects of Caregiving tool is a brief tool that asks questions about caregiving experiences that made the caregiver feel good about providing care.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start6 Mar 2025
- Primary completion22 Oct 2025
- Study completion22 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will be assigned to intervention groups where they will receive structured education and support.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Sheria Robinson-Lane, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04856462
- Sponsor's protocol ID
- HUM00230940
- Other IDs
- 1K01AG065420-01A1
- Status last verified
- Mar 2026
- First submitted
- 19 Apr 2021
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It is anticipated that the following data will be generated and made available 1) published tables, figures, graphs, and tables of data used for making graphs; 2) published journal papers, conference papers, annual reports and the final report; and 3) educational materials resulting from intervention development. All data will conform with relevant data and terminology standards.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Alzheimer's Companion Engagement (ACE) Project.
- ClinicalTrials.gov ID
- NCT04856462
- Acronym / sponsor ID
- HUM00230940
- Conditions
- Stress, Psychological, Adaptation, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 6 Mar 2025 (actual)
- Primary completion
- 22 Oct 2025 (actual)
- Study completion
- 22 Oct 2025 (actual)
- First posted
- 23 Apr 2021 (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.
Black family caregivers of older adults with Alzheimer's disease and/or related dementias (ADRD), have an increased mortality risk related to pre-existing health conditions and stress. Targeted, culturally responsive, health interventions that help Black ADRD caregivers to effectively manage their own health and use community preferenced ways of coping, can improve caregivers' overall health, perceived ability to provide care for a person with ADRD (self-efficacy), and increases the likelihood that they will experience benefits from caregiving. This clinical trial pilot will test the feasibility of a community based intervention designed to improve health outcomes for Black family caregivers of persons with ADRD.
Detailed description
The proposed intervention is a peer-supportive and facilitator-led video teleconference program that will engage small groups of caregivers weekly over 6 weeks. Each week participants (n = 36, 2-5/group) will receive a different culturally relevant caregiving or personal health strategy to practice. During the support calls, a facilitator will provide an overview of the content covered and each participant will have the opportunity to discuss their past week and how they engaged the weekly strategy, or challenges that came up for them during the week. The format will be structured to ensure that core content is reviewed, and everyone can be equally engaged while flexible enough that caregivers can receive support in the areas they need. A battery of assessment measures will be taken at weeks 1 and 8.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will be assigned to intervention groups where they will receive structured education and support.
| Arm | Type | Receives |
|---|---|---|
| Caregiver Support | Experimental | Behavioral: Education SupportAll participants in all groups will receive 6 weeks of caregiving support including a weekly video/teleconference call, and handouts covering relevant educational topics) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Self-identified as Black/ African American At least 18 years old Able to speak, understand, and hear spoken English Related to, or has a close personal relationship to a person over the age of 55 that has an ADRD diagnosis or evidence of cognitive impairment Regular access to a smartphone, tablet or computer with internet access that will allow video conferencing engagement.
- Provides monitoring, and assistance in activities of daily living and or other care tasks for the care recipient.
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Education SupportCaregivers engage in a weekly video/teleconference support group with a skilled facilitator to discuss various strategies for managing caregiving stress, challenging behaviors, and personal self-care. | Behavioural | Caregiver Support |
Primary outcome
Caregiver Self-efficacy
Time frame: 6 weeks
Caregiver self-efficacy will be measured by the Revised Scale for Caregiving Self-Efficacy, which evaluates the caregivers' ability to obtain respite care, respond to disruptive behaviors, and control one's own upsetting thoughts about caregiving.
1 secondary outcome
Positive Aspects of Caregiving
Time frame: 6 weeks
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 27 Mar 2026.
- Individual participant dataSharing planned: Yes. It is anticipated that the following data will be generated and made available 1) published tables, figures, graphs, and tables of data used for making graphs; 2) published journal papers, conference papers, annual reports and the final report; and 3) educational materials resulting from intervention development. All data will conform with relevant data and terminology standards.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education Support in people with Stress, Psychological and Adaptation, Psychological, run by University of Michigan 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 3 inclusion and 0 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 27 Mar 2026. 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 Self-efficacy (time frame: 6 weeks). 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 27 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.