Social ConnectednessNCT05274074
Social-LEAF Life Enhancing Activities for Caregivers
A study testing Social LEAF in people with Social Connectedness, run by University of Rochester at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Connectedness
- What is being tested?
- Social LEAF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2022to 23 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Care Partner Outcomes Through Positive Connections
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).
Read the detailed description
The objective of the Social-LEAF study is to examine psychological mechanisms whereby Social LEAF delivered in a group and via video call reduces loneliness and improves positive emotions for older caregivers of loved ones with DLB. This is an 18-month Stage 2 study examining Social LEAF, which is strengths-based and teaches positive coping skills focused on improving social relationships and is delivered remotely in a group format. These two adaptations to the original LEAF intervention are included to provide a more potent means of improving social connection. A pilot phase with up to 20 caregivers (Aim 1) will address these adaptations regarding feasibility, acceptability, and signal for reducing loneliness, with refinements as needed. A second phase (Aims 2 and 3) will involve a randomized trial comparing Social LEAF to control (30 caregivers in each arm) on loneliness (primary outcome), positive affect (mechanism), and social engagement (mechanism). Data will also be collected on acceptability and perceived benefits using mixed methods.
Aim 1 is to refine the LEAF intervention to target social relationships and loneliness.
Aim 2 is to examine feasibility and acceptability of Social LEAF for DLB caregivers.
Aim 3 is to examine efficacy of Social LEAF in reducing loneliness, increasing positive affect, and increasing social engagement.
- Conditions
- Social Connectedness
- Being tested
- Social LEAF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social LEAFBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Wait-List Control | No intervention | The wait-list control had a 6 week waiting period after which they received the Social LEAF intervention |
| Intervention | Experimental | Social LEAF is an adaptation of the Life Enhancing Activities for Family Caregivers program to focus on social relationships and loneliness.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 maintenance 6 weeks after the end of the intervention. Receives: Behavioral: Social LEAF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Reported Outcome Measurement Information System (PROMIS )Positive Affect
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.
Measured: Week 6
Secondary outcomes (5)
Berkman-Syme Social Network Index
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.
Measured: Week 6
Patient Reported Outcome Measurement Information System (PROMIS) Social Isolation
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.
Measured: Week 6
Patient Reported Outcome Measurement Information System (PROMIS) Satisfaction Role Activities
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.
Measured: Week 6
Positive Aspects of Caregiving Scale
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.
Measured: Week 6
University of California Los Angeles (UCLA) Loneliness Scale
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.
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start28 Jul 2022
- Primary completion23 Jul 2023
- Study completion23 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Social ConnectednessStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Benzi Kluger, MD, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274074
- Sponsor's protocol ID
- 375254
- Other IDs
- P30AG064103
- Status last verified
- Feb 2025
- First submitted
- 27 Jan 2022
- Last updated
- 3 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data will be made available upon request and after review by the study team.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Care Partner Outcomes Through Positive Connections
- ClinicalTrials.gov ID
- NCT05274074
- Acronym / sponsor ID
- 375254
- Conditions
- Social Connectedness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 28 Jul 2022 (actual)
- Primary completion
- 23 Jul 2023 (actual)
- Study completion
- 23 Jul 2023 (actual)
- First posted
- 10 Mar 2022 (actual)
- Results
- Posted 3 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The objective of the Social-LEAF study is to examine psychological mechanisms whereby Social LEAF delivered in a group and via video call reduces loneliness and improves positive emotions for older caregivers of loved ones with DLB. This is an 18-month Stage 2 study examining Social LEAF, which is strengths-based and teaches positive coping skills focused on improving social relationships and is delivered remotely in a group format. These two adaptations to the original LEAF intervention are included to provide a more potent means of improving social connection. A pilot phase with up to 20 caregivers (Aim 1) will address these adaptations regarding feasibility, acceptability, and signal for reducing loneliness, with refinements as needed. A second phase (Aims 2 and 3) will involve a randomized trial comparing Social LEAF to control (30 caregivers in each arm) on loneliness (primary outcome), positive affect (mechanism), and social engagement (mechanism). Data will also be collected on acceptability and perceived benefits using mixed methods.
Aim 1 is to refine the LEAF intervention to target social relationships and loneliness.
Aim 2 is to examine feasibility and acceptability of Social LEAF for DLB caregivers.
Aim 3 is to examine efficacy of Social LEAF in reducing loneliness, increasing positive affect, and increasing social engagement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wait-List Control | No intervention | –The wait-list control had a 6 week waiting period after which they received the Social LEAF intervention |
| Intervention | Experimental | Behavioral: Social LEAFSocial LEAF is an adaptation of the Life Enhancing Activities for Family Caregivers program to focus on social relationships and loneliness.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 maintenance 6 weeks after the end of the intervention. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social LEAFSocial 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. | Behavioural | Intervention |
Primary outcome
Patient Reported Outcome Measurement Information System (PROMIS )Positive Affect
Time frame: 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.
5 secondary outcomes
Berkman-Syme Social Network Index
Time frame: Week 6
Patient Reported Outcome Measurement Information System (PROMIS) Social Isolation
Time frame: Week 6
Patient Reported Outcome Measurement Information System (PROMIS) Satisfaction Role Activities
Time frame: Week 6
Positive Aspects of Caregiving Scale
Time frame: Week 6
University of California Los Angeles (UCLA) Loneliness Scale
Time frame: Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified individual patient data will be made available upon request and after review by the study team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social LEAF in people with Social Connectedness, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Reported Outcome Measurement Information System (PROMIS )Positive Affect (time frame: Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.