Trial Outcomes & Findings for Social-LEAF Life Enhancing Activities for Caregivers (NCT NCT05274074)

Last Updated: 2025-03-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

58 participants

Primary outcome timeframe

Week 6

Results posted on

2025-03-03

Participant Flow

Participant milestones

Participant milestones
Measure	Wait-List Control The wait-list control had a 6 week waiting period after which they had the option of doing the intervention.	Intervention We will be utilizing the Life Enhancing Activities or Caregivers (LEAF) intervention to display that social networks' can be used as a means of reinforcing the positive life skills of the intervention; and that these same skills will enhance social networks, increase mutual satisfaction in social interactions, and boost motivation to reach out to others, thus combatting social isolation. This group received the intervention for 6 weeks and we looked at maintenance 6 weeks after the end of the intervention. Social LEAF: Social LEAF is an adaptation of the Life Enhancing Activities for Family Caregivers program to focus on social relationships and loneliness. Social LEAF is a six-session group program provided by video-conference that teaches caregivers coping skills to improve social relationships and social connection. Social LEAF is delivered in groups of up to 10 caregivers via videoconference and will consist of six weekly hour-long discussion-based classes to teach positive coping skills around improving social relationships. Each week will focus on a skill from the original LEAF study adapted to the group and social context.
Overall Study STARTED	29	29
Overall Study COMPLETED	26	24
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Wait-List Control The wait-list control had a 6 week waiting period after which they had the option of doing the intervention.	Intervention We will be utilizing the Life Enhancing Activities or Caregivers (LEAF) intervention to display that social networks' can be used as a means of reinforcing the positive life skills of the intervention; and that these same skills will enhance social networks, increase mutual satisfaction in social interactions, and boost motivation to reach out to others, thus combatting social isolation. This group received the intervention for 6 weeks and we looked at maintenance 6 weeks after the end of the intervention. Social LEAF: Social LEAF is an adaptation of the Life Enhancing Activities for Family Caregivers program to focus on social relationships and loneliness. Social LEAF is a six-session group program provided by video-conference that teaches caregivers coping skills to improve social relationships and social connection. Social LEAF is delivered in groups of up to 10 caregivers via videoconference and will consist of six weekly hour-long discussion-based classes to teach positive coping skills around improving social relationships. Each week will focus on a skill from the original LEAF study adapted to the group and social context.
Overall Study Lost to Follow-up	2	3
Overall Study Withdrawal by Subject	1	2

Baseline Characteristics

3 participants did not complete the baseline Positive Affect Measure

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Week 6

Population: Caregivers of persons with Lewy-body dementia were randomized to intervention and wait-list control groups. Nine participants did not complete either baseline or the 6-week measure.

Outcome measures

Outcome measures
Measure	Wait-List Control n=25 Participants The wait-list control had a 6 week waiting period after which they had the option of doing the intervention.	Intervention n=24 Participants We utilized the Life Enhancing Activities or Caregivers (LEAF) intervention to display that social networks' can be used as a means of reinforcing the positive life skills of the intervention; and that these same skills will enhance social networks, increase mutual satisfaction in social interactions, and boost motivation to reach out to others, thus combatting social isolation. This group received the intervention for 6 weeks and we looked at outcomes at week 6 post-intervention. Social LEAF: Social LEAF is an adaptation of the Life Enhancing Activities for Family Caregivers program to focus on social relationships and loneliness. Social LEAF was a six-session group program provided by video-conference that taught caregivers coping skills to improve social relationships and social connection. Social LEAF was delivered in groups of up to 10 caregivers via videoconference and consisted of six weekly hour-long discussion-based classes to teach positive coping skills around improving social relationships. Each week focused on a skill from the original LEAF study adapted to the group and social context.
Patient Reported Outcome Measurement Information System (PROMIS )Positive Affect	-1.7 units on a scale Interval -5.1 to 1.7	-0.3 units on a scale Interval -3.8 to 3.1

SECONDARY outcome

Timeframe: Week 6

Population: Caregivers of persons with Lewy-body dementia were randomized to intervention and wait-list control groups. Eight participants did not complete either baseline or the 6-week measure.

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 to every few months = 0; greater than or equal to once or twice a month = 1)). The total index range is 0-4 with a higher score indicative of better social network.

Outcome measures

Outcome measures
Measure	Wait-List Control n=26 Participants The wait-list control had a 6 week waiting period after which they had the option of doing the intervention.	Intervention n=24 Participants We utilized the Life Enhancing Activities or Caregivers (LEAF) intervention to display that social networks' can be used as a means of reinforcing the positive life skills of the intervention; and that these same skills will enhance social networks, increase mutual satisfaction in social interactions, and boost motivation to reach out to others, thus combatting social isolation. This group received the intervention for 6 weeks and we looked at outcomes at week 6 post-intervention. Social LEAF: Social LEAF is an adaptation of the Life Enhancing Activities for Family Caregivers program to focus on social relationships and loneliness. Social LEAF was a six-session group program provided by video-conference that taught caregivers coping skills to improve social relationships and social connection. Social LEAF was delivered in groups of up to 10 caregivers via videoconference and consisted of six weekly hour-long discussion-based classes to teach positive coping skills around improving social relationships. Each week focused on a skill from the original LEAF study adapted to the group and social context.
Berkman-Syme Social Network Index	-0.8 units on a scale Interval -1.0 to -0.6	-0.9 units on a scale Interval -1.2 to -0.7

SECONDARY outcome

Timeframe: Week 6

Population: Caregivers of persons with Lewy-body dementia were randomized to intervention and wait-list control groups. Eight participants did not complete either baseline or the 6-week measure.

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.

Outcome measures

Outcome measures
Measure	Wait-List Control n=26 Participants The wait-list control had a 6 week waiting period after which they had the option of doing the intervention.	Intervention n=24 Participants We utilized the Life Enhancing Activities or Caregivers (LEAF) intervention to display that social networks' can be used as a means of reinforcing the positive life skills of the intervention; and that these same skills will enhance social networks, increase mutual satisfaction in social interactions, and boost motivation to reach out to others, thus combatting social isolation. This group received the intervention for 6 weeks and we looked at outcomes at week 6 post-intervention. Social LEAF: Social LEAF is an adaptation of the Life Enhancing Activities for Family Caregivers program to focus on social relationships and loneliness. Social LEAF was a six-session group program provided by video-conference that taught caregivers coping skills to improve social relationships and social connection. Social LEAF was delivered in groups of up to 10 caregivers via videoconference and consisted of six weekly hour-long discussion-based classes to teach positive coping skills around improving social relationships. Each week focused on a skill from the original LEAF study adapted to the group and social context.
Patient Reported Outcome Measurement Information System (PROMIS) Social Isolation	0.9 units on a scale Interval -0.7 to 2.5	-0.1 units on a scale Interval -1.7 to 1.6

SECONDARY outcome

Timeframe: Week 6

Population: Caregivers of persons with Lewy-body dementia were randomized to intervention and wait-list control groups. Eight participants did not complete either baseline or the 6-week measure.

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.

Outcome measures

Outcome measures
Measure	Wait-List Control n=26 Participants The wait-list control had a 6 week waiting period after which they had the option of doing the intervention.	Intervention n=24 Participants We utilized the Life Enhancing Activities or Caregivers (LEAF) intervention to display that social networks' can be used as a means of reinforcing the positive life skills of the intervention; and that these same skills will enhance social networks, increase mutual satisfaction in social interactions, and boost motivation to reach out to others, thus combatting social isolation. This group received the intervention for 6 weeks and we looked at outcomes at week 6 post-intervention. Social LEAF: Social LEAF is an adaptation of the Life Enhancing Activities for Family Caregivers program to focus on social relationships and loneliness. Social LEAF was a six-session group program provided by video-conference that taught caregivers coping skills to improve social relationships and social connection. Social LEAF was delivered in groups of up to 10 caregivers via videoconference and consisted of six weekly hour-long discussion-based classes to teach positive coping skills around improving social relationships. Each week focused on a skill from the original LEAF study adapted to the group and social context.
Patient Reported Outcome Measurement Information System (PROMIS) Satisfaction Role Activities	-0.1 units on a scale Interval -1.8 to 1.6	-1.0 units on a scale Interval -2.9 to 0.8

SECONDARY outcome

Timeframe: Week 6

Population: Caregivers of persons with Lewy-body dementia were randomized to intervention and wait-list control groups. Eight participants did not complete either baseline or the 6-week measure. Caregivers of persons with Lewy-body dementia were randomized to intervention and wait-list control groups. Eight participants did not complete either baseline or the 6-week measure.

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.

Outcome measures

Outcome measures
Measure	Wait-List Control n=26 Participants The wait-list control had a 6 week waiting period after which they had the option of doing the intervention.	Intervention n=24 Participants We utilized the Life Enhancing Activities or Caregivers (LEAF) intervention to display that social networks' can be used as a means of reinforcing the positive life skills of the intervention; and that these same skills will enhance social networks, increase mutual satisfaction in social interactions, and boost motivation to reach out to others, thus combatting social isolation. This group received the intervention for 6 weeks and we looked at outcomes at week 6 post-intervention. Social LEAF: Social LEAF is an adaptation of the Life Enhancing Activities for Family Caregivers program to focus on social relationships and loneliness. Social LEAF was a six-session group program provided by video-conference that taught caregivers coping skills to improve social relationships and social connection. Social LEAF was delivered in groups of up to 10 caregivers via videoconference and consisted of six weekly hour-long discussion-based classes to teach positive coping skills around improving social relationships. Each week focused on a skill from the original LEAF study adapted to the group and social context.
Positive Aspects of Caregiving Scale	-0.8 units on a scale Interval -2.8 to 1.1	2.5 units on a scale Interval 0.4 to 4.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Wait-List Control n=26 Participants The wait-list control had a 6 week waiting period after which they had the option of doing the intervention.	Intervention n=24 Participants We utilized the Life Enhancing Activities or Caregivers (LEAF) intervention to display that social networks' can be used as a means of reinforcing the positive life skills of the intervention; and that these same skills will enhance social networks, increase mutual satisfaction in social interactions, and boost motivation to reach out to others, thus combatting social isolation. This group received the intervention for 6 weeks and we looked at outcomes at week 6 post-intervention. Social LEAF: Social LEAF is an adaptation of the Life Enhancing Activities for Family Caregivers program to focus on social relationships and loneliness. Social LEAF was a six-session group program provided by video-conference that taught caregivers coping skills to improve social relationships and social connection. Social LEAF was delivered in groups of up to 10 caregivers via videoconference and consisted of six weekly hour-long discussion-based classes to teach positive coping skills around improving social relationships. Each week focused on a skill from the original LEAF study adapted to the group and social context.
University of California Los Angeles (UCLA) Loneliness Scale	0.6 units on a scale Interval -2.2 to 3.5	-0.2 units on a scale Interval -3.1 to 2.8

Adverse Events

Wait-List Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Benzi M. Kluger

University of Rochester

Phone: 5852754259

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Wait-List Control n=29 Participants The wait-list control had a 6 week waiting period after which they had the option of doing the intervention.	Intervention n=29 Participants We will be utilizing the Life Enhancing Activities or Caregivers (LEAF) intervention to display that social networks' can be used as a means of reinforcing the positive life skills of the intervention; and that these same skills will enhance social networks, increase mutual satisfaction in social interactions, and boost motivation to reach out to others, thus combatting social isolation. This group received the intervention for 6 weeks and we looked at maintenance 6 weeks after the end of the intervention. Social LEAF: Social LEAF is an adaptation of the Life Enhancing Activities for Family Caregivers program to focus on social relationships and loneliness. Social LEAF is a six-session group program provided by video-conference that teaches caregivers coping skills to improve social relationships and social connection. Social LEAF is delivered in groups of up to 10 caregivers via videoconference and will consist of six weekly hour-long discussion-based classes to teach positive coping skills around improving social relationships. Each week will focus on a skill from the original LEAF study adapted to the group and social context.	Total n=58 Participants Total of all reporting groups
Age, Continuous	66 years STANDARD_DEVIATION 12 • n=29 Participants	67 years STANDARD_DEVIATION 13 • n=29 Participants	67 years STANDARD_DEVIATION 13 • n=58 Participants
Sex: Female, Male Female	26 Participants n=29 Participants	26 Participants n=29 Participants	52 Participants n=58 Participants
Sex: Female, Male Male	3 Participants n=29 Participants	3 Participants n=29 Participants	6 Participants n=58 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=29 Participants	3 Participants n=29 Participants	4 Participants n=58 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=29 Participants	26 Participants n=29 Participants	54 Participants n=58 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=29 Participants	0 Participants n=29 Participants	0 Participants n=58 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=29 Participants	0 Participants n=29 Participants	0 Participants n=58 Participants
Race (NIH/OMB) Asian	0 Participants n=29 Participants	0 Participants n=29 Participants	0 Participants n=58 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=29 Participants	0 Participants n=29 Participants	0 Participants n=58 Participants
Race (NIH/OMB) Black or African American	2 Participants n=29 Participants	1 Participants n=29 Participants	3 Participants n=58 Participants
Race (NIH/OMB) White	26 Participants n=29 Participants	27 Participants n=29 Participants	53 Participants n=58 Participants
Race (NIH/OMB) More than one race	0 Participants n=29 Participants	0 Participants n=29 Participants	0 Participants n=58 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=29 Participants	1 Participants n=29 Participants	2 Participants n=58 Participants
Region of Enrollment United States	29 participants n=29 Participants	29 participants n=29 Participants	58 participants n=58 Participants
PROMIS Positive Affect	41.9 units on scale STANDARD_DEVIATION 8.8 • n=27 Participants • 3 participants did not complete the baseline Positive Affect Measure	45.5 units on scale STANDARD_DEVIATION 8.5 • n=28 Participants • 3 participants did not complete the baseline Positive Affect Measure	43.7 units on scale STANDARD_DEVIATION 8.8 • n=55 Participants • 3 participants did not complete the baseline Positive Affect Measure