Improving social connections for lonely caregivers
Modifiers and Mechanisms of Loneliness Interventions
This study is testing a new digital tool and coaching program to see if it can help lonely caregivers of loved ones with Alzheimer's feel more connected and supported.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 57 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | University of Rochester Academic / other |
| Locations | 1 site (Rochester, New York) |
| Trial ID | NCT05812989 on ClinicalTrials.gov |
What this trial studies
This research aims to explore how emotion regulation affects caregivers' responses to a behavioral coaching intervention designed to reduce loneliness. It will also evaluate the effectiveness of a digital tool that prioritizes social engagement to enhance the fidelity of the intervention and improve outcomes for caregivers. The study involves a randomized clinical trial over 19 months, focusing on caregivers aged 50 and older who care for loved ones with Alzheimer's disease or related dementia. The goal is to identify modifiable factors that can help reduce loneliness and enhance social connectedness among caregivers.
Who should consider this trial
Good fit: Ideal candidates are caregivers aged 50 or older who experience elevated distress and loneliness while caring for someone with Alzheimer's disease or related dementia.
Not a fit: Patients who do not speak English or have significant cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide caregivers with effective strategies to reduce loneliness and improve their overall well-being.
How similar studies have performed: Other studies have shown promise in using behavioral interventions to reduce loneliness, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Caregiver (age 50 or older) for a community-dwelling loved one with Alzheimer's disease or related dementia (ADRD), living with (or in close proximity to) the person with ADRD. * Elevated caregiving distress: above population mean (\>11) on 10-item Perceived Stress Scale (PSS-10) and/or at least moderate caregiver strain (score \>= 5) on the Modified Caregiver Strain Index. * Social disconnection: UCLA Loneliness Scale: Short Form score of \> 5. Exclusion Criteria: * Non-English speaking * Significant cognitive impairment * Major cardiovascular conditions that may interfere with reliable assessment of HRV (e.g., congestive heart failure, pacemaker, prior myocardial infarction).
Where this trial is running
Rochester, New York
- University of Rochester — Rochester, New York, United States (Recruiting)
Study contacts
- Principal investigator: Kathi L Heffner, PhD — University of Rochester
- Study coordinator: Kathi L Heffner, PhD
- Email: kathi_heffner@urmc.rochester.edu
- Phone: 585-273-4786
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.