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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up this will be documented throughout the study and calculated in the last month of the study.
Awards & highlights
Study Summary
This trial is looking at a way to reduce loneliness in caregivers of people with Alzheimer's by increasing their sense of meaning and purpose in life.
Who is the study for?
This trial is for adult care partners of community-dwelling persons with Alzheimer's disease or related disorders (AD/ADRD) who feel lonely, as indicated by a specific loneliness scale. Participants must not be professional caregivers but rather family members or friends, speak English, have the ability to use technology like email and internet, and their role cannot be linked to employment.Check my eligibility
What is being tested?
The RELOAD-C program aims to reduce loneliness in AD/ADRD care partners by enhancing their sense of meaning and purpose through Meaning-Centered Psychotherapy (MCP). It includes videos on MCP concepts, virtual group meetings for discussion, and additional written content. The study will test these components' usability and effectiveness compared to usual care.See study design
What are the potential side effects?
As this intervention involves psychological support via web-based platforms without medical treatments or drugs involved, traditional side effects are not expected. However, participants may experience emotional discomfort discussing personal experiences during therapy sessions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ this measure will be administered at baseline and 6 weeks and 3 months post-baseline.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~this measure will be administered at baseline and 6 weeks and 3 months post-baseline.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Care Partners' Loneliness between baseline and 3 months post-baseline
Secondary outcome measures
Change in Care partner burden between baseline and 3 months post-baseline
Change in Depression between baseline and 3 months post-baseline
Change in Distress between baseline and 3 months post-baseline.
+5 moreOther outcome measures
Change in Meaning in Life between baseline and 3 months post-baseline.
Demographic and Clinical History
Exploratory outcome: Change in Behavioral and Psychological Symptoms of Dementia between pre-randomization and 3 months post-randomization
+3 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Intervention Arm 2Experimental Treatment1 Intervention
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.
Group II: Intervention Arm 1Experimental Treatment1 Intervention
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.
Group III: Usual CareActive Control1 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.
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Who is running the clinical trial?
Northwell HealthLead Sponsor
460 Previous Clinical Trials
470,947 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,829 Total Patients Enrolled
13 Trials studying Loneliness
3,050 Patients Enrolled for Loneliness
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot communicate in English.I am mentally capable of understanding and participating in the trial.I am 18 years old or older.I am younger than 18 years old.I am the main caregiver for someone with Alzheimer's or dementia living at home.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Arm 1
- Group 2: Intervention Arm 2
- Group 3: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment open for recruitment?
"Based on the data found on clinicaltrials.gov, this experiment is no longer seeking participants. Though it was initially posted June 1st 2024 and most recently updated July 12th 2022, there are currently 39 other studies actively recruiting patients."
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