Caregiver BurdenPhase 2Pair 2 CareNCT07868718
Peer Support for Family Caregivers of Older Adults Living With Dementia
A Phase 2 study testing Peer Support in people with Caregiver Burden and Caregiver Burnout, run by Ohio State University at 1 site in United States.
Trial summary
Family caregivers of people living with dementia are at high risk of poor health when caregiving for their loved one. Peer Support for Family Caregivers of Older Adults Living with Dementia (Pair 2 Care©) is a simple, nonjudgmental, flexible, and potentially scalable peer support program developed with and for family… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregiver Burden, Caregiver Burnout, Caregiver Anxiety
- What is being tested?
- Peer Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 344 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Aug 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- English-speaking
- Adult (18+)
- Family Caregivers of people living with dementia (current or former)
Who cannot join
- Non-English-speaking
- Under age 18
- Non-family caregiver
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Ohio State University College of Nursing
Columbus, Ohio, 43210
Karen O Moss, PhD, 614-688-3100, moss.391@osu.edu
Sandra L Solove, MA, 614-247-8366, solove.3@osu.edu
About this study
Official title: A Randomized Controlled Trial of Peer Support for Family Caregivers of Black Older Adults Living With Dementia (Pair 2 Care)
Family caregivers of people living with dementia are at high risk of poor health when caregiving for their loved one. Peer Support for Family Caregivers of Older Adults Living with Dementia (Pair 2 Care©) is a simple, nonjudgmental, flexible, and potentially scalable peer support program developed with and for family caregivers along with former (previous) caregivers, community leaders, and healthcare providers. Using the experiences of trained former caregivers as mentors to current caregiver mentees, Pair 2 Care© may lower caregiver depressive symptoms and promote health and well-being of current caregivers, their loved ones, and former caregivers while informing future Alzheimer's disease and Alzheimer's disease-related dementia caregiving policy.
Read the detailed description
Family care partners (FCP) of older adults living with Alzheimer's disease and Alzheimer's disease-related dementias (AD/ADRD) are at high risk of adverse health effects of caregiving. AD/ADRD prevalence can be as high as 18.6% in some high-risk populations versus 10% in the general public overall. Combined with late or missed diagnosis, this leads to neuropsychological symptom management, healthcare planning, physical, spiritual, and psychosocial challenges for FCPs. Support interventions are needed to assist high-risk AD/ADRD FCP populations. Peer Support for Family Caregivers of Older Adults Living with Dementia (Pair 2 Care) is a peer support intervention that is delivered virtually. Our team, in collaboration with current and former FCPs, community leaders, and healthcare providers, developed Pair 2 Care. Pair 2 Care© leverages the experiential expertise of former AD/ADRD FCPs (care recipient is deceased) who serve as trained mentors to current FCP mentees. Pair 2 Care was found to be feasible and acceptable based on completion of total participant enrollment (N=26), mentor training, and FCP mentee-mentor pairing in only 10 weeks. Mentors were retained at 90% and FCP mentees at 93% for this 6-month intervention. Participants rated their overall Pair 2 Care satisfaction as very high (4.6/5.0). The study team hypothesize that Pair 2 Care will result in better FCP mentee outcomes (reduced depressive symptoms, anxiety, and loneliness and greater social support, quality of life, and self-efficacy) compared to controls. The study team will conduct a two-arm randomized controlled trial (n=172 FCP mentees; n=86 intervention group; n=86 enhanced usual care control group). The specific aims of this study are to (1) determine Pair 2 Care intervention efficacy on FCP mentee depressive symptoms (primary outcome), anxiety, social support, loneliness, quality of life, and self-efficacy for surrogate decision making; (2) examine the associations between FCP mentee and mentor individual characteristics and variations in engagement quality (i.e., frequency and mode of connection, program satisfaction) with Pair 2 Care©; and (3) determine the impact on the mentor's well-being, identity restoration, meaning in life, and loneliness following Pair 2 Care intervention participation using mixed-methods analyses. This study will provide important intervention efficacy data for this innovative, simple, evidence-based, potentially scalable approach to addressing the needs of FCPs providing support to people living with AD/ADRD. Pair 2 Care has the potential to inform important AD/ADRD caregiving-related policy.
- Being tested
- Peer Support, Usual Care
- Keywords
- ADRD caregivers, virtual peer-delivered intervention, Depression, Caregiver, ADRD, dementia, dementia caregiving, anxiety
- Medical subject headings
- Caregiver Burden, Depression, Dementia, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer SupportBehavioural
Former caregivers will be paired with a current caregiver based on a similar personal attribute (e.g., relationship to care recipient). Each pair will complete at least five virtual face-to-face (video) interactions and at least 10 other interactions either via phone call, email, or text messaging over the 6-month time period.
Usual CareBehavioural
Will include AD/ADRD and caregiving literature, as the control condition because it will provide a more real-world comparison. After completing the Month 6 data collection, they will be offered the Pair 2 Care intervention.
| Study group | Role | What they receive |
|---|---|---|
| Peer Support | Experimental | Former caregivers will be paired with a current caregivers Receives: Behavioral: Peer Support |
| Active Control | Active comparator | Participants will receive usual care conditions Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Center for Epidemiologic Studies Depression Scale Revised (CESD-R-10)
The Center for Epidemiologic Studies Depression Scale Revised (CESD-R-10) will be used to measure depressive symptoms.74 The CESD-R-10 is reliable (Cronbach's α = .86) and valid (convergent = .91; divergent = .89).
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionAug 2031 (estimated)
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurdenStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Pair 2 Care is an innovative, award-winning, 6-month, 100% remote (face-to-face via video such as Zoom or FaceTime, telephone, email, and text message) peer support intervention designed with and for current and former Family Caregiver Participants (FCP) of high-risk people living with AD/ADRD. Trained former FCP mentors provide peer mentorship to current FCPs based on their caregiving experiences and per the study protocol. The PI and project manager will conduct bimonthly research team training blitzes, including interaction scenarios, to help ensure consistency in team member interactions with participants.
- Masking
- None (open label)
- Enrolment
- 344 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Karen O Moss, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868718
- Sponsor's protocol ID
- STUDY20260586
- Other IDs
- 1R01AG097585-01A1
- Acronym
- Pair 2 Care
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 14 Oct 2026
- 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 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Peer Support for Family Caregivers of Black Older Adults Living With Dementia (Pair 2 Care)
- ClinicalTrials.gov ID
- NCT07868718
- Acronym / sponsor ID
- Pair 2 Care / STUDY20260586
- Keywords
- ADRD caregivers, virtual peer-delivered intervention, Depression, Caregiver, ADRD, dementia, dementia caregiving, anxiety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 344 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Dec 2026 (estimated)
- Primary completion
- Aug 2031 (estimated)
- Study completion
- Aug 2031 (estimated)
- First posted
- 9 Oct 2026 (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.
Family caregivers of people living with dementia are at high risk of poor health when caregiving for their loved one. Peer Support for Family Caregivers of Older Adults Living with Dementia (Pair 2 Care©) is a simple, nonjudgmental, flexible, and potentially scalable peer support program developed with and for family caregivers along with former (previous) caregivers, community leaders, and healthcare providers. Using the experiences of trained former caregivers as mentors to current caregiver mentees, Pair 2 Care© may lower caregiver depressive symptoms and promote health and well-being of current caregivers, their loved ones, and former caregivers while informing future Alzheimer's disease and Alzheimer's disease-related dementia caregiving policy.
Detailed description
Family care partners (FCP) of older adults living with Alzheimer's disease and Alzheimer's disease-related dementias (AD/ADRD) are at high risk of adverse health effects of caregiving. AD/ADRD prevalence can be as high as 18.6% in some high-risk populations versus 10% in the general public overall. Combined with late or missed diagnosis, this leads to neuropsychological symptom management, healthcare planning, physical, spiritual, and psychosocial challenges for FCPs. Support interventions are needed to assist high-risk AD/ADRD FCP populations. Peer Support for Family Caregivers of Older Adults Living with Dementia (Pair 2 Care) is a peer support intervention that is delivered virtually. Our team, in collaboration with current and former FCPs, community leaders, and healthcare providers, developed Pair 2 Care. Pair 2 Care© leverages the experiential expertise of former AD/ADRD FCPs (care recipient is deceased) who serve as trained mentors to current FCP mentees. Pair 2 Care was found to be feasible and acceptable based on completion of total participant enrollment (N=26), mentor training, and FCP mentee-mentor pairing in only 10 weeks. Mentors were retained at 90% and FCP mentees at 93% for this 6-month intervention. Participants rated their overall Pair 2 Care satisfaction as very high (4.6/5.0). The study team hypothesize that Pair 2 Care will result in better FCP mentee outcomes (reduced depressive symptoms, anxiety, and loneliness and greater social support, quality of life, and self-efficacy) compared to controls. The study team will conduct a two-arm randomized controlled trial (n=172 FCP mentees; n=86 intervention group; n=86 enhanced usual care control group). The specific aims of this study are to (1) determine Pair 2 Care intervention efficacy on FCP mentee depressive symptoms (primary outcome), anxiety, social support, loneliness, quality of life, and self-efficacy for surrogate decision making; (2) examine the associations between FCP mentee and mentor individual characteristics and variations in engagement quality (i.e., frequency and mode of connection, program satisfaction) with Pair 2 Care©; and (3) determine the impact on the mentor's well-being, identity restoration, meaning in life, and loneliness following Pair 2 Care intervention participation using mixed-methods analyses. This study will provide important intervention efficacy data for this innovative, simple, evidence-based, potentially scalable approach to addressing the needs of FCPs providing support to people living with AD/ADRD. Pair 2 Care has the potential to inform important AD/ADRD caregiving-related policy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pair 2 Care is an innovative, award-winning, 6-month, 100% remote (face-to-face via video such as Zoom or FaceTime, telephone, email, and text message) peer support intervention designed with and for current and former Family Caregiver Participants (FCP) of high-risk people living with AD/ADRD. Trained former FCP mentors provide peer mentorship to current FCPs based on their caregiving experiences and per the study protocol. The PI and project manager will conduct bimonthly research team training blitzes, including interaction scenarios, to help ensure consistency in team member interactions with participants.
| Arm | Type | Receives |
|---|---|---|
| Peer Support | Experimental | Behavioral: Peer SupportFormer caregivers will be paired with a current caregivers |
| Active Control | Active comparator | Behavioral: Usual CareParticipants will receive usual care conditions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English-speaking
- Adult (18+)
- Family Caregivers of people living with dementia (current or former)
Key exclusion criteria (3 listed)
- Non-English-speaking
- Under age 18
- Non-family caregiver
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 |
|---|---|---|
| Peer SupportFormer caregivers will be paired with a current caregiver based on a similar personal attribute (e.g., relationship to care recipient). Each pair will complete at least five virtual face-to-face (video) interactions and at least 10 other interactions either via phone call, email, or text messaging over the 6-month time period. | Behavioural | Peer Support |
| Usual CareWill include AD/ADRD and caregiving literature, as the control condition because it will provide a more real-world comparison. After completing the Month 6 data collection, they will be offered the Pair 2 Care intervention. | Behavioural | Active Control |
Primary outcome
Center for Epidemiologic Studies Depression Scale Revised (CESD-R-10)
Time frame: Baseline, 3 months, 6 months
The Center for Epidemiologic Studies Depression Scale Revised (CESD-R-10) will be used to measure depressive symptoms.74 The CESD-R-10 is reliable (Cronbach's α = .86) and valid (convergent = .91; divergent = .89).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- 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.
Karen O Moss, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Peer Support in people with Caregiver Burden and Caregiver Burnout, run by Ohio State University 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 3 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: opening soon, as of the sponsor's last update on 14 Oct 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karen O Moss, PhD ((614) 688-3100, Moss.391@osu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Center for Epidemiologic Studies Depression Scale Revised (CESD-R-10) (time frame: Baseline, 3 months, 6 months). 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 14 Oct 2026.