RELOAD-C for Loneliness

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Northwell Health, Institute of Health System Science, Manhasset, NY
Loneliness
RELOAD-C - Behavioral
Eligibility
18+
All Sexes
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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-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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: This will be documented throughout the study and calculated in the last month of the study.

Month 3
Change in Care partner burden between pre-randomization and 3 months post-randomization
Change in Meaning in Life between pre-randomization and 3 months post-randomization.
Exploratory outcome: Change in Behavioral and Psychological Symptoms of Dementia between pre-randomization and 3 months post-randomization
Month 3
Change in Depression and Anxiety between pre-randomization and 3 months post-randomization
Change in Distress between pre-randomization and 3 months post-randomization
Month 3
Change in Care Partners' Loneliness between pre-randomization and 3 months post-randomization
This will be completed at baseline (pre-randomization)
Demographic and Clinical History
This will be documented throughout the study and calculated in the last month of the study.
Feasibility of conducting a future RCT: Engagement in RELOAD-C
Feasibility of conducting a future RCT: percent consented
Feasibility of conducting a future RCT: percent drop-out

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Usual Care
1 of 3
Intervention Arm 2
1 of 3
Intervention Arm 1
1 of 3
Active Control
Experimental Treatment

96 Total Participants · 3 Treatment Groups

Primary Treatment: RELOAD-C · No Placebo Group · N/A

Intervention Arm 2
Behavioral
Experimental Group · 1 Intervention: RELOAD-C · Intervention Types: Behavioral
Intervention Arm 1
Behavioral
Experimental Group · 1 Intervention: RELOAD-C · Intervention Types: Behavioral
Usual CareNoIntervention Group · 1 Intervention: Usual Care · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: this will be documented throughout the study and calculated in the last month of the study.
Closest Location: Northwell Health, Institute of Health System Science · Manhasset, NY
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N/AFirst Recorded Clinical Trial
1 TrialsResearching Loneliness
0 CompletedClinical Trials

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,348 Previous Clinical Trials
3,261,801 Total Patients Enrolled
9 Trials studying Loneliness
2,989 Patients Enrolled for Loneliness
Northwell HealthLead Sponsor
409 Previous Clinical Trials
290,114 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
• Self-identify as the primary care partner of a community-dwelling (i.e.
You are a care partner of the patient.\n
The criterion is that the care partner must be lonely.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.