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NCT05460494Completed

Reduce Loneliness in Care Partners of Persons With AD/ADRD

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

Source: ClinicalTrials.gov · Last updated 6 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
96 (actual)
First submitted
27 Jun 2022
Start date
6 Mar 2024
Primary completion date
12 Jan 2026
Lead sponsor
Northwell Health
NCT number
NCT05460494

What you commit to

  • Study type: Interventional
  • Participants enrolled: 96
  • From 6 Mar 2024 to the primary completion date, 12 Jan 2026
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • could not have participated in previous Aims (1 or 2) of this study

Age

  • Under the age of 18

Other

  • Unable to communicate in English
  • only one care partner per patient will be allowed to participate

Who the study is looking for

  • • Self-identify as the care partner of a community-dwelling (i.e. does not live in a nursing home or facility) person with AD/ADRD (diagnosis confirmed via the patients' electronic health record when possible)
    • report that their role as a care partner is not related to their employment (i.e. they are a family member or friend of the patient)
    • age 18 or older
    • English-speaking
    • competency to participate
    • access to a telephone, computer, Internet and email
    • care partners must be lonely, defined as scoring ≥35 on the UCLA Loneliness Scale

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Northwell Health, Institute of Health System Science
Coordinator of this site? Confirm its status
ManhassetUnited StatesUnknown status
Geriatrics and Palliative Medicine
Coordinator of this site? Confirm its status
New Hyde ParkUnited StatesUnknown status
Geriatric Medicine, Lenox Hill Hospital
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Staten Island University South Hospital
Coordinator of this site? Confirm its status
Staten IslandUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.