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NCT05460494 · ClinicalTrials.gov registry record · NA
Reduce Loneliness in Care Partners of Persons With AD/ADRD
A NA study of Loneliness, sponsored by Northwell Health.
- Recruiting
- Registry status
- NA
- Development phase
- 96
- Enrollment target
- 4
- Study locations
NCT05460494: Recruiting NA study of Loneliness, sponsored by Northwell Health.
NCT05460494 is a NA study of Loneliness that is actively recruiting participants, run by Northwell Health. The registered enrollment target is 96 participants, below the 407-participant average among 35 other Loneliness trials with a reported enrollment target (76% lower). The trial reports 4 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05460494, a NA study of Loneliness, is actively recruiting participants, sponsored by Northwell Health.
- RECRUITING
- Registry status
- NA
- Development phase
- 96 participants
- Enrollment target
- 4
- Study locations
Study 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-
Primary Outcome
Our primary outcome is care partners' loneliness, defined as the distressing experience that occurs when a person's social relationships are perceived by that person to be less in quantity, and especially in quality, than desired. Care partners' loneliness will be evaluated with the 20-item UCLA Loneliness Scale, a reliable and valid continuous measure for overall, emotional and social loneliness.
Conditions Studied
Interventions
- BEHAVIORAL RELOAD-C
Study Locations (4)
New York
- Northwell Health, Institute of Health System Science - Manhasset
- Geriatrics and Palliative Medicine - New Hyde Park
- Geriatric Medicine, Lenox Hill Hospital - New York
- Staten Island University South Hospital - Staten Island
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2024-03-06 |
| Est. Completion | 2026-01-31 |
| Phase | NA |
What NCT05460494 shows while recruiting
NCT05460494 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 407-participant average among 35 other Loneliness trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Loneliness appearing as the primary indexed condition, and to 1 intervention - of which RELOAD-C is the first listed.
NCT05460494 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05460494 about?
NCT05460494 is a clinical study titled "Reduce Loneliness in Care Partners of Persons With AD/ADRD". 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 concep...
What is the current status of trial NCT05460494?
This trial is currently recruiting. It is a NA study. The enrollment target is 96 participants. The study started on 2024-03-06. Estimated completion is 2026-01-31.
What conditions does trial NCT05460494 study?
This clinical trial studies the following conditions: Loneliness.
What interventions are being tested in trial NCT05460494?
The interventions under investigation include: RELOAD-C (BEHAVIORAL).
Who is sponsoring clinical trial NCT05460494?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05460494 being conducted?
This trial has 4 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Loneliness
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05460494's enrollment target sits among peer trials
96 18th of 35 higher than 17 of 35 other Loneliness trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Loneliness trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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