SAGE-LEAF: Reducing Burden in Alzheimer's Disease Caregivers Through Positive Emotion Regulation and Virtual Support (SAGE-LEAF)
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SAGE LEAF
Sponsored by
About this trial
This is an interventional supportive care trial for Alzheimer Disease focused on measuring Alzheimer's Disease and Related Dementias, Caregiver
Eligibility Criteria
Inclusion Criteria:
- Adults age 18 and over who identify as the primary caregiver of a family member with Alzheimer's Disease
- Co-reside with the family caregiver
- Speak and read English
- Have internet access and a reliable email address
Exclusion Criteria:
- None
Sites / Locations
- Northwestern University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention (single arm)
Arm Description
5 session self-guided online delivered positive emotion regulation intervention with social components.
Outcomes
Primary Outcome Measures
Percentage of Skill Pages in SAGE-LEAF Accessed by a Participant
This is to measure adherence to SAGE-LEAF intervention. Score range: 0-100%. A higher percentage means better adherence to the SAGE-LEAF intervention.
Willingness to Recommend SAGE-LEAF to Other AD Caregivers
This is to measure the acceptability of SAGE-LEAF. Score range: 1-10. A higher score indicates higher acceptability.
System Usability Scale
This is to measure the usability of SAGE-LEAF. Score range: 0-100. A higher score indicates better usability.
Secondary Outcome Measures
Zarit Burden Interview
Measuring caregiving burden. Score range: 0-88. Higher scores indicate greater burden.
Oberst Caregiving Burden Scale - Time
Measuring caregiving burden in terms of time. Score range: 1-5. Higher scores indicate higher levels of caregiver burden.
Oberst Caregiving Burden Scale - Difficulty
Measuring caregiving burden in terms of difficulty. Score range: 1-5. Higher scores indicate higher levels of caregiver burden.
Positive Aspects of Caregiving Scale
Measuring positive aspects to caregiving for dementia patients. Score range: 5-45. Higher scores indicate better caregivers' outlook on life and self-affirmations.
Role Captivity Sub-scale of Caregiver Reaction Assessment
Measuring role captivity in caregiving. Score 1-4. Higher scores indicate stronger feelings of role captivity.
Overload Sub-scale of Caregiver Reaction Assessment
Measuring the feeling of overload in caregiving. Score 1-4. Higher scores indicate stronger feelings of overload.
Caregiving Mastery Subscale of the Caregiving Appraisal Measure
Measuring caregiving mastery. Score range: 1-5. Higher scores indicate better caregiving mastery.
Cohen's Perceived Stress Scale
Measuring perceived stress. Score range: 0-40. Higher scores indicate higher levels of perceived stress
Positive Affect in Differential Emotions Scale
Measuring positive emotions. Score range: 1-5. Higher scores indicate higher levels of positive emotions.
Negative Affect in Differential Emotions Scale
Measuring positive emotions. Score range: 1-5. Higher scores indicate higher levels of negative emotions.
Patient-Reported Outcomes Measurement Information System - Depression
Measuring depression level. Score range: 20-80. Higher scores indicate higher depression levels.
Patient-Reported Outcomes Measurement Information System - Anxiety
Measuring anxiety level. Score range: 20-80. Higher scores indicate higher anxiety levels.
Patient-Reported Outcomes Measurement Information System - Sleep Disturbance
Measuring sleep disturbance level. Score range: 20-80. Higher scores indicate higher levels of sleep disturbance.
Patient-Reported Outcomes Measurement Information System - Meaning and Purpose
Measuring one's sense of life having purpose and that there are good reasons for living. Score range: 20-80. Higher scores indicate hopefulness, optimism, goal-directedness, and feelings that one's life is worthy.
Patient-Reported Outcomes Measurement Information System - Social Isolation
Measuring perceptions of being avoided, excluded, detached, disconnected from, or unknown by, others. Score range: 20-80. Higher scores indicate higher levels of perception of social isolation.
Full Information
NCT ID
NCT05562583
First Posted
September 18, 2022
Last Updated
September 30, 2023
Sponsor
BrightOutcome
Collaborators
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT05562583
Brief Title
SAGE-LEAF: Reducing Burden in Alzheimer's Disease Caregivers Through Positive Emotion Regulation and Virtual Support
Acronym
SAGE-LEAF
Official Title
SAGE-LEAF: Reducing Burden in Alzheimer's Disease Caregivers Through Positive Emotion Regulation and Virtual Support
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
BrightOutcome
Collaborators
Northwestern University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of the proposed study, is to adapt a positive emotion intervention for Alzheimer's Disease (AD) caregivers into a self-guided online format that incorporates social connection components and adaptive system feedback mechanisms to promote intervention adherence. Previous tests of the facilitated version of the program, called SAGE-LEAF (Social Augmentation to self-Guided Electronic delivery of the Life Enhancing Activities for Family caregivers), have shown efficacy for improving well-being in dementia caregivers. If effective, the SAGE-LEAF program can be disseminated to Alzheimer's caregivers nationwide through AD treatment and research centers.
Detailed Description
The prevalence of Alzheimer's Disease (AD) and other dementias is steadily climbing and predicted to affect as many as 16 million Americans by 2050. In 2016, 59% of dementia caregivers reported experiencing high levels of emotional and physical stress, and the risk that the chronic stress of dementia caregiving places on caregivers for developing a range of physical and mental health issues is extensively documented. Caregiving-related stress contributes to social isolation, loneliness, and physical illness and increases the risk of caregiver death. Interventions for dementia caregivers have primarily focused on reducing negative emotions and burden. However, over the past few decades, it has become clear that positive emotions are uniquely related to better psychological and physical well-being, independent of the effects of negative emotion suggesting that an intervention that specifically targets positive emotion holds promise for improving caregiver well-being and, ultimately, quality of care for the individual living with AD. The investigators' recent randomized trial of the positive emotion skills intervention, delivered by trained facilitators via the web in N = 170 family caregivers of people with dementia resulted in significant improvements in caregiver psychological well being. However, facilitator-delivered interventions are costly and difficult to implement with fidelity on a large scale. Furthermore, a major challenge to advancing behavioral interventions delivered by trained facilitators is assuring fidelity. The investigators have developed a self-guided online version of the intervention that has shown feasibility and acceptability in several samples, but this version does not capture the critical social connection aspects of the facilitator-delivered intervention. The investigators propose to take the next step toward closing the science-to-practice gap for the positive emotion regulation intervention by tailoring the self-guided online version specifically for dementia caregivers that incorporates the social connection components to combat the loneliness and isolation experienced by many Alzheimer's caregivers. The intervention, called SAGE-LEAF (Social Augmentation of self-Guided Electronic delivery of the Life Enhancing Activities for Family caregivers), leverages the lessons learned from the original LEAF project and adapts its positive emotion intervention to AD caregivers in a self-guided format while incorporating social connection components and adaptive system feedback mechanisms to promote intervention adherence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Alzheimer's Disease and Related Dementias, Caregiver
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention (single arm)
Arm Type
Experimental
Arm Description
5 session self-guided online delivered positive emotion regulation intervention with social components.
Intervention Type
Behavioral
Intervention Name(s)
SAGE LEAF
Intervention Description
SAGE LEAF covers 8 skills and each skill has related home-practice activities that "unlock" every week. Each week will consist of 1-2 days of didactic material and 5-6 days of real-life home practice. Participants can access the skills at their own leisure and as often as they'd like within that week. Participants cannot skip modules with didactic material and can only progress to the next lesson if they have completed the current one. However, participants can return to old lessons or exercises if they choose to do so at a later time.
Primary Outcome Measure Information:
Title
Percentage of Skill Pages in SAGE-LEAF Accessed by a Participant
Description
This is to measure adherence to SAGE-LEAF intervention. Score range: 0-100%. A higher percentage means better adherence to the SAGE-LEAF intervention.
Time Frame
Post-study (week 6)
Title
Willingness to Recommend SAGE-LEAF to Other AD Caregivers
Description
This is to measure the acceptability of SAGE-LEAF. Score range: 1-10. A higher score indicates higher acceptability.
Time Frame
Post-study (week 6)
Title
System Usability Scale
Description
This is to measure the usability of SAGE-LEAF. Score range: 0-100. A higher score indicates better usability.
Time Frame
Post-study (week 6)
Secondary Outcome Measure Information:
Title
Zarit Burden Interview
Description
Measuring caregiving burden. Score range: 0-88. Higher scores indicate greater burden.
Time Frame
Pre-study and post-study (week 6)
Title
Oberst Caregiving Burden Scale - Time
Description
Measuring caregiving burden in terms of time. Score range: 1-5. Higher scores indicate higher levels of caregiver burden.
Time Frame
Pre-study and post-study (week 6)
Title
Oberst Caregiving Burden Scale - Difficulty
Description
Measuring caregiving burden in terms of difficulty. Score range: 1-5. Higher scores indicate higher levels of caregiver burden.
Time Frame
Pre-study and post-study (week 6)
Title
Positive Aspects of Caregiving Scale
Description
Measuring positive aspects to caregiving for dementia patients. Score range: 5-45. Higher scores indicate better caregivers' outlook on life and self-affirmations.
Time Frame
Pre-study and post-study (week 6)
Title
Role Captivity Sub-scale of Caregiver Reaction Assessment
Description
Measuring role captivity in caregiving. Score 1-4. Higher scores indicate stronger feelings of role captivity.
Time Frame
Pre-study and post-study (week 6)
Title
Overload Sub-scale of Caregiver Reaction Assessment
Description
Measuring the feeling of overload in caregiving. Score 1-4. Higher scores indicate stronger feelings of overload.
Time Frame
Pre-study and post-study (week 6)
Title
Caregiving Mastery Subscale of the Caregiving Appraisal Measure
Description
Measuring caregiving mastery. Score range: 1-5. Higher scores indicate better caregiving mastery.
Time Frame
Pre-study and post-study (week 6)
Title
Cohen's Perceived Stress Scale
Description
Measuring perceived stress. Score range: 0-40. Higher scores indicate higher levels of perceived stress
Time Frame
Pre-study and post-study (week 6)
Title
Positive Affect in Differential Emotions Scale
Description
Measuring positive emotions. Score range: 1-5. Higher scores indicate higher levels of positive emotions.
Time Frame
Pre-study and post-study (week 6)
Title
Negative Affect in Differential Emotions Scale
Description
Measuring positive emotions. Score range: 1-5. Higher scores indicate higher levels of negative emotions.
Time Frame
Pre-study and post-study (week 6)
Title
Patient-Reported Outcomes Measurement Information System - Depression
Description
Measuring depression level. Score range: 20-80. Higher scores indicate higher depression levels.
Time Frame
Pre-study and post-study (week 6)
Title
Patient-Reported Outcomes Measurement Information System - Anxiety
Description
Measuring anxiety level. Score range: 20-80. Higher scores indicate higher anxiety levels.
Time Frame
Pre-study and post-study (week 6)
Title
Patient-Reported Outcomes Measurement Information System - Sleep Disturbance
Description
Measuring sleep disturbance level. Score range: 20-80. Higher scores indicate higher levels of sleep disturbance.
Time Frame
Pre-study and post-study (week 6)
Title
Patient-Reported Outcomes Measurement Information System - Meaning and Purpose
Description
Measuring one's sense of life having purpose and that there are good reasons for living. Score range: 20-80. Higher scores indicate hopefulness, optimism, goal-directedness, and feelings that one's life is worthy.
Time Frame
Pre-study and post-study (week 6)
Title
Patient-Reported Outcomes Measurement Information System - Social Isolation
Description
Measuring perceptions of being avoided, excluded, detached, disconnected from, or unknown by, others. Score range: 20-80. Higher scores indicate higher levels of perception of social isolation.
Time Frame
Pre-study and post-study (week 6)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults age 18 and over who identify as the primary caregiver of a family member with Alzheimer's Disease
Co-reside with the family caregiver
Speak and read English
Have internet access and a reliable email address
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DerShung Yang, PhD
Organizational Affiliation
BrightOutcome, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Judith T Moskowitz, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
37672311
Citation
Kwok I, Lattie EG, Yang D, Summers A, Grote V, Cotten P, Moskowitz JT. Acceptability and Feasibility of a Socially Enhanced, Self-Guided, Positive Emotion Regulation Intervention for Caregivers of Individuals With Dementia: Pilot Intervention Study. JMIR Aging. 2023 Sep 6;6:e46269. doi: 10.2196/46269.
Results Reference
background
Learn more about this trial
SAGE-LEAF: Reducing Burden in Alzheimer's Disease Caregivers Through Positive Emotion Regulation and Virtual Support
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