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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

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Official record

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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
What is being tested?
Peer Support
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

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.

Karen O Moss, PhD contact

(614) 688-3100

Moss.391@osu.edu

Sandra L Solove, MA contact

614-247-8366

solove.3@osu.edu

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

Other trials in United States

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 groups in NCT07868718
Study groupRoleWhat they receive
Peer SupportExperimentalFormer caregivers will be paired with a current caregivers
Receives: Behavioral: Peer Support
Active ControlActive comparatorParticipants 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.

  1. 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.

  1. First posted9 Oct 2026
  2. Study startDec 2026 (estimated)
  3. Primary completionAug 2031 (estimated)
  4. Study completionAug 2031 (estimated)

Resources

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)
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

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