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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 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.
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-
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05460494
The ClinicalTrials.gov registry entry for NCT05460494 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 407-participant average among 35 other Loneliness trials with a reported enrollment target (76% lower). The listed sponsor is Northwell Health, which has 370 total studies on file at ClinicalTrials.gov.
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 4 study locations spanning 1 distinct geographic area - top geographies include 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.
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Related
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