NCT05274074

Social-LEAF Life Enhancing Activities for Caregivers

Completed NA Results posted Last updated 3 March 2025

What this trial tests

NA trial testing Social LEAF in Social Connectedness in 58 participants. Completed in 23 July 2023.

Timeline

28 July 2022

Primary endpoint
23 July 2023

23 July 2023

Quick facts

Lead sponsor	University of Rochester
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	58
Start date	28 July 2022
Primary completion	23 July 2023
Estimated completion	23 July 2023
Sites	1 location across United States

Drugs / interventions tested

• Social LEAF

Conditions studied

• Social Connectedness — all drugs for Social Connectedness →

Sponsor

University of Rochester

Who can join

50 and older, any sex, with Social Connectedness. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Patient Reported Outcome Measurement Information System (PROMIS )Positive Affect Primary · Week 6

Change in the Patient Reported Outcomes Measurement Information System (PROMIS)- Positive Affect from Baseline to Week 6. This is a 15-item scale measuring momentary positive affective experiences over the past 7 days. It is a five-point Likert-type scale (i.e.,"not at all, a little bit, somewhat, quite a bit, very much") resulting in 15-75 scale. Scores are summed to create a raw score. Individual items are positively skewed with 5 options from "Not at all" to "Very much." Higher scores indicate better positive affect and are a better outcome.

Group	Value	95% CI
Wait-List Control	-1.7	-5.1 – 1.7
Intervention	-0.3	-3.8 – 3.1

Berkman-Syme Social Network Index Secondary · Week 6

Change in the Berkman-Syme Social Network Index from baseline to week 6. This scale is used to measure social isolation and loneliness and includes subjective experiences of connection to contacts. This measure is a questionnaire to assess the type, size, closeness, and frequency of contacts in a respondent's current social network. This index is the sum of four binary items (Married (no = 0; yes = 1); close friends and relatives (0-2 friends and 0-2 relatives = 0; all other scores = 1); group participation (no = 0; yes = 1); participation in religious meetings or services (less than or equal

Group	Value	95% CI
Wait-List Control	-0.8	-1.0 – -0.6
Intervention	-0.9	-1.2 – -0.7

Patient Reported Outcome Measurement Information System (PROMIS) Social Isolation Secondary · Week 6

Change in the Patient Reported Outcome Measurement Information System (PROMIS)- Social Isolation from baseline to week 6. This scale assesses perceptions of being avoided, excluded, detached, disconnected from by others. The measure has a Likert Scale (1-5 with 1 being Never and 5 being Always). Raw scores were converted to a T-score, a standardized score with a mean of 50 and a standard deviation of 10. Lower scores indicate lesser social isolation and are therefore a better outcome.

Group	Value	95% CI
Waitlist Control	0.9	-0.7 – 2.5
Intervention Group	-0.1	-1.7 – 1.6

Patient Reported Outcome Measurement Information System (PROMIS) Satisfaction Role Activities Secondary · Week 6

Change in the PROMIS V 2.0 Satisfaction Role Activities from baseline to week 6. This scale assessed caregivers satisfaction level in their participation in relaxation and leisure activities.The measure has a Likert Scale (1-5 with 1 being Not at all and 5 being Very much). Raw scores were converted to a T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher satisfaction and are therefore a better outcome.

Group	Value	95% CI
Waitlist Control	-0.1	-1.8 – 1.6
Intervention Group	-1.0	-2.9 – 0.8

Positive Aspects of Caregiving Scale Secondary · Week 6

Change in the Positive Aspects of Caregiving Scale from baseline to week 6. This scale consists of nine items assessing positive consequences of caregiving, each rated on a 0-4 Likert scale (range of scores 0-36), where a higher score reflects a more positive perception of the caregiving experience.

Group	Value	95% CI
Wait-List Control	-0.8	-2.8 – 1.1
Intervention	2.5	0.4 – 4.6

University of California Los Angeles (UCLA) Loneliness Scale Secondary · Week 6

Change in the UCLA Loneliness scale from baseline to week 6. This scale produces a continuous score of the degree to which participants endorse loneliness. The measure has 20 items with a Likert scale of 1-4 with 1 being Never and 4 being Always resulting in a 20-80 scale. Lower scores indicate better outcome.

Group	Value	95% CI
Wait-List Control	0.6	-2.2 – 3.5
Intervention	-0.2	-3.1 – 2.8

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.