RecruitingNot ApplicableNCT05460494

Reduce Loneliness in Care Partners of Persons With AD/ADRD

Increasing Meaning to Reduce Loneliness in Care Partners of Persons With AD/ADRD


Sponsor

Northwell Health

Enrollment

96 participants

Start Date

Mar 6, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

More than 60% of care partners of persons with AD/ADRD report feeling lonely. Building on the existing evidence that increasing meaning and purpose in life is a strong predictor of decreased loneliness, interventions to reduce loneliness in this population may be strengthened by incorporating concepts from Meaning-Centered Psychotherapy (MCP). Thus, the overall goal of the proposed project is to reduce loneliness in care partners of patients with AD/ADRD through increasing their sense of meaning and purpose in life using concepts from MCP, delivered via a web-based platform, RELOAD-C (REducing LOneliness in Alzeheimer's Disease-Care Partners). This will be achieved through three Specific Aims. Aim 1 consists of three phases (preparatory work, stakeholder involvement with N=15 AD/ADRD care partners, and adaptation of the existing web-based platform) to produce RELOAD-C, which centralizes: 1) 6 brief videos portraying an MCP expert delivering MCP concepts; 2) links to 7 virtual group meetings (6 weekly + 1 booster) to discuss MCP concepts (of note, the support groups utilized in this study exist only as part of this research); and 3) written content expanding on the material from the MCP videos. Aim 2 evaluates usability/acceptability of RELOAD-C (defined as a task success rate ≥ 78%, and scores ≥ 68 on the System Usability Scale) with N=20 care partners of persons with AD/ADRD. Aim 3 proposes a pilot RCT to evaluate the preliminary efficacy of the RELOAD-C components (MCP videos vs. MCP-focused group discussions) in reducing loneliness and feasibility of conducting a future, large-scale RCT. N=96 AD/ADRD care partners will be randomized to: usual care, n=32; MCP videos alone via RELOAD-C, n=32; or MCP videos + weekly groups via RELOAD-C, n=32. Care partners' outcomes will be assessed at baseline, and 6-weeks and 3-months post-baseline. The investigators expect the effect sizes will be in the moderate range (.3). Feasibility is defined as: ≥ 75% consented, ≤ 30% drop-out, and 80% engagement with intervention. Reducing loneliness among care partners is of high public health significance and incorporating MCP in loneliness interventions is highly innovative. In sum, the investigators will enroll 15 care partners during Aim 1, 20 care partners during Aim 2, and 96 care partners during Aim 3.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an intervention designed to reduce loneliness and improve wellbeing in family members and friends who care for someone living with Alzheimer's disease or a related dementia. Caregivers often experience significant isolation, and this trial evaluates whether a structured support program can meaningfully reduce that burden. **You may be eligible if...** - You are the primary caregiver for someone living with Alzheimer's disease or dementia who is not in a nursing home - Your caregiving role is unpaid (not a professional position) - You experience loneliness or social isolation connected to your caregiving responsibilities - You are willing to engage with the program activities **You may NOT be eligible if...** - Your caregiving is a paid professional role - The person you care for lives in a residential care facility - You are not experiencing loneliness related to caregiving Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALRELOAD-C

RELOAD-C is a web-based platform that centralizes 6 brief videos of our MCP expert (Dr. Applebaum) discussing sources of meaning, links to virtual group meetings facilitated by a social worker trained in MCP to promote discussion of MCP concepts, and written content providing guidance on homework and exercises referenced in the MCP videos


Locations(4)

Northwell Health, Institute of Health System Science

Manhasset, New York, United States

Geriatrics and Palliative Medicine

New Hyde Park, New York, United States

Geriatric Medicine, Lenox Hill Hospital

New York, New York, United States

Staten Island University South Hospital

Staten Island, New York, United States

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NCT05460494


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