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| ID | Type | Description | Link |
|---|---|---|---|
| P30AG064103 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Social LEAF | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
De-identified individual patient data will be made available upon request and after review by the study team.
After publication of main manuscript
Requesting investigators will need to provide a rationale for their request and plan for results. Depending on request, a Data User Agreement may also be required.
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| ID | Title | Description |
|---|---|---|
| FG000 | Wait-List Control | The wait-list control had a 6 week waiting period after which they had the option of doing the intervention. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Wait-List Control | The wait-list control had a 6 week waiting period after which they had the option of doing the intervention. |
| BG001 | 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. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Week 6 |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Wait-List Control | The wait-list control had a 6 week waiting period after which they received the intervention. |
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This is a small pilot trial. The intent was primarily to assess feasibility.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Benzi M. Kluger | University of Rochester | 5852754259 | benzi_kluger@urmc.rochester.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 31, 2023 | Jan 15, 2025 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 9, 2025 | Jan 31, 2025 | SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 31, 2023 | Feb 3, 2025 | ICF_004.pdf |
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| 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. | 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. | 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. | 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. | Week 6 |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| PROMIS Positive Affect | The Patient Reported Outcomes Measurement Information System (PROMIS)- Positive Affect 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"). 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. | 3 participants did not complete the baseline Positive Affect Measure | Mean | Standard Deviation | units on scale |
|
The wait-list control had a 6 week waiting period after which they had the option of doing the intervention.
| OG001 | Intervention | 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. |
|
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| Secondary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Week 6 |
|
|
|
|
| Secondary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Week 6 |
|
|
|
|
| Secondary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Week 6 |
|
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|
|
| Secondary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Week 6 |
|
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|
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| Secondary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Week 6 |
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| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Intervention | 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. | 0 | 29 | 0 | 29 | 0 | 29 |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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