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Not recruiting

Observational Study

Sponsor:

Northwell Health

Code:

NCT05460494

Conditions

Loneliness

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RELOAD-C

Study Details

Brief 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.

Conditions

Loneliness

Study ID

NCT05460494

Start date

Mar 6, 2024

Status verified date

Apr, 2025

Completion date

Jan 31, 2026

Anticipated

Primary completion date

Jan 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • • 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

Exclusion Criteria:

  • Unable to communicate in English
  • Under the age of 18
  • only one care partner per patient will be allowed to participate
  • could not have participated in previous Aims (1 or 2) of this study

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Usual Care

Usual care for AD/ADRD care partners consists of a screen for burden, and potential referral to AD/ADRD social workers and the AD helpline.

experimental: Intervention Arm 1

MCP videos alone. Care partners randomized to intervention arm 1 during Step 2 randomization will receive usual care + RELOAD-C, consisting of: 1) 6 brief (\~5 minute) videos of Dr. Allison Applebaum introducing concepts from MCP for care partners of persons with AD/ADRD; and 2) written content associated with the videos, such as directions for homework assignments. The tab with links to the virtual group meetings will be removed. Participants in this arm use RELOAD-C on their own and do not have interaction with other care partners while using the platform. One video will become available for viewing each week for the first 6 weeks after randomization, and each care partner will have a unique user ID/login.

experimental: Intervention Arm 2

MCP videos + MCP-focused virtual groups. In addition to the components that the intervention arm 1 participants receive (6 MCP videos, written text), the RELOAD-C platform for the intervention arm 2 participants will include links to the virtual group meetings (7 in total). The first 6 group meetings will occur weekly. Each of the first 6 group meetings will facilitate discussion of the MCP concepts introduced in that week's video, as participants receive access to each video \~3 days prior to the group meeting. The 7th virtual meeting will be used as a "booster" in week 9, and will focus on sharing how participants are using the MCP concepts in their daily lives. All meetings will be facilitated by our social worker, Katherine Henthorne, LCSW.

Interventions

RELOAD-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

Primary outcome measure

  • Change in Care Partners' Loneliness between baseline and 3 months post-baseline [ Time Frame: This measure will be given at consent as a screening measure, at baseline, and 6 weeks and 3 months post-baseline. ]

Central Contacts and Locations

Central contacts

Locations

Geriatrics and Palliative Medicine

Recruiting

New Hyde Park, New York, United States, 11042

Contacts

Allison Marziliano, PhD

amarzilian@northwell.edu

Geriatric Medicine, Lenox Hill Hospital

Recruiting

New York, New York, United States, 10075

Contacts

Allison Marziliano, PhD

amarzilian@northwell.edu

Staten Island University South Hospital

Recruiting

Staten Island, New York, United States, 10309

More Information

Sponsor

Northwell Health

Last update posted

Apr 11, 2025

Last verified

Apr, 2025

Keywords

  • Alzheimer's Disease
  • Care Partners
  • Loneliness
  • Web-based
  • Meaning

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Northwell Health on 2025-04-11.