N/A
N=58
Social-LEAF Life Enhancing Activities for Caregivers
Social Connectedness
Bottom Line
View on ClinicalTrials.gov: NCT05274074 ↗Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Patient Reported Outcome Measurement Information System (PROMIS )Positive Affect — -1.7; -0.3 units on a scale — p=0.57
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Social LEAF (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Reported Outcome Measurement Information System (PROMIS )Positive Affect |
-1.7; -0.3 | 0.57 |
| SECONDARY Berkman-Syme Social Network Index |
-0.8; -0.9 | 0.53 |
| SECONDARY Patient Reported Outcome Measurement Information System (PROMIS) Social Isolation |
0.9; -0.1 | 0.41 |
| SECONDARY Patient Reported Outcome Measurement Information System (PROMIS) Satisfaction Role Activities |
-0.1; -1.0 | 0.45 |
| SECONDARY Positive Aspects of Caregiving Scale |
-0.8; 2.5 | 0.02 sig |
| SECONDARY University of California Los Angeles (UCLA) Loneliness Scale |
0.6; -0.2 | 0.69 |
Summary
This study examines a behavioral intervention to improve social connection and reduce loneliness for caregivers of a loved one with Dementia with Lewy Bodies (DLB).
Eligibility Criteria
Inclusion criteria
- Must be a primary care partner of a person that has been clinically diagnosed with Dementia with Lewy Bodies (DLB) or Parkinson's Disease Dementia, and has access to high-speed internet connection at home or in a location where they can speak privately with a facilitator. iPads and a hotspot will be given to those who lack internet and a sufficient mobile device but show willingness to participate. The iPads and hotspot will be returned to the study team once study procedures have concluded. Must be willing and ready to begin the intervention either immediately or in 6 weeks depending on which group they are randomly selected to be in.
- Must begin LEAF procedures as soon as consented to the study. Has not taken part in Aim 1 of the study.
- Will have waited the 6-week period before starting LEAF procedures after consenting and has not taken part in Aim 1 of the study.
Exclusion Criteria
- Not a primary care partner of a person with DLB. Is a primary care partner of someone who has not been clinically diagnosed with DLB. Cannot speak English or provide clear and concise consent to the project.
- Has not started LEAF procedures at the beginning and has taken part in Aim 1 of the study.
- Has started/taken part in the LEAF procedures at the beginning and also has taken part in Aim 1 of the study.
Data sourced from ClinicalTrials.gov (NCT05274074). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.