RECRUITING

Reduce Loneliness in Care Partners of Persons With AD/ADRD

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-03-06
Study Completion:2026-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05460494

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * • Self-identify as the primary 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)
  2. * 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)
  3. * age 18 or older
  4. * English-speaking
  5. * competency to participate
  6. * access to a telephone, computer, Internet and email
  7. * care partners must be lonely, defined as scoring ≥35 on the UCLA Loneliness Scale
  1. * Unable to communicate in English
  2. * Under the age of 18
  3. * only one care partner per patient will be allowed to participate
  4. * could not have participated in previous Aims (1 or 2) of this study

Contacts and Locations

Study Contact

Allison Marziliano, PhD
CONTACT
516-600-1440
amarzilian@northwell.edu
Michael Diefenbach, PhD
CONTACT
516-600-1440
mdiefenbach@northwell.edu

Study Locations (Sites)

Northwell Health, Institute of Health System Science
Manhasset, New York, 10022
United States
Geriatrics and Palliative Medicine
New Hyde Park, New York, 11042
United States
Geriatric Medicine, Lenox Hill Hospital
New York, New York, 10075
United States

Collaborators and Investigators

Sponsor: Northwell Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-06
Study Completion Date2026-09-30

Study Record Updates

Study Start Date2024-03-06
Study Completion Date2026-09-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Loneliness