Reduce Loneliness in Care Partners of Persons With AD/ADRD

NCT05460494 | Recruiting

• 2 other identifiers: 21-12641K01AG076888-01
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 4

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Care Partners' Loneliness between baseline and 3 months post-baseline

  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.

  This measure will be given at consent as a screening measure, at baseline, and 6 weeks and 3 months post-baseline.

Secondary Outcomes (8)

• Change in Depression between baseline and 3 months post-baseline

  This measure will be administered to care partners at baseline, and 6 weeks and 3 months post-baseline.

• Change in Distress between baseline and 3 months post-baseline.

  This measure will be administered to care partners at baseline, and 6 weeks and 3 months post-baseline.

• Change in Care partner burden between baseline and 3 months post-baseline

  This measure will be administered to care partners at baseline, and 6 weeks and 3 months post baseline.

• Change in Quality of Life between baseline and 3 months post-baseline

  This measure will be administered at baseline and 6 weeks and 3 months post-baseline.

• Change in social isolation between baseline and 3 months post-baseline

  This measure will be administered at baseline and 6 weeks and 3 months post-baseline.

Other Outcomes (6)

• Exploratory outcome: Change in Behavioral and Psychological Symptoms of Dementia between pre-randomization and 3 months post-randomization

  This measure will be administered to care partners at baseline and 6 weeks and 3 months post baseline.

• Demographic and Clinical History

  This will be completed at pre-randomization/right after consent.

• Change in Meaning in Life between baseline and 3 months post-baseline.

  This measure will be administered to care partners at baseline, and 6 weeks and 3 months post baseline.

Study Arms (3)

Usual Care

NO INTERVENTION

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.

Intervention Arm 1

EXPERIMENTAL

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.

Behavioral: RELOAD-C

Intervention Arm 2

EXPERIMENTAL

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.

Behavioral: RELOAD-C

Interventions

RELOAD-C BEHAVIORAL

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

Intervention Arm 1; Intervention Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead
• National Institute on Aging (NIA): collaborator

Study Sites (4)

Northwell Health, Institute of Health System Science

Manhasset, New York, 10022, United States

NOT YET RECRUITING

Geriatrics and Palliative Medicine

New Hyde Park, New York, 11042, United States

RECRUITING

Geriatric Medicine, Lenox Hill Hospital

New York, New York, 10075, United States

RECRUITING

Staten Island University South Hospital

Staten Island, New York, 10309, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Allison Marziliano, PhD

CONTACT

516-600-1440; amarzilian@northwell.edu

Michael Diefenbach, PhD

CONTACT

516-600-1440; mdiefenbach@northwell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Study participants will be blinded to which arm they are randomized to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Modified cluster randomized controlled trial with randomization

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 15, 2022
• Study Start: March 6, 2024
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: required by U.S. Law. This Web site will not include information that can identify participants. We will make the data available to other researchers by the on-line publication date, unless the NIA requests an earlier date.
• Access Criteria: only the research team that is on the IRB-approved protocol can access identifiable data. Any data that is publicly accessible will be de-identified.

Locations

US (4)