Clinical trial NCT05562583: SAGE-LEAF: Reducing Burden in Alzheimer's Disease Caregivers Through Positive Emotion Regulation and Virtual Support
Official title: SAGE-LEAF: Reducing Burden in Alzheimer's Disease Caregivers Through Positive Emotion Regulation and Virtual Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Keywords: Alzheimer's Disease and Related Dementias
Caregiver
Lead sponsor: BrightOutcome
Sponsor class: INDUSTRY
Collaborators: name: Northwestern University
First posted: 2022-10-03
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Percentage of Skill Pages in SAGE-LEAF Accessed by a Participant
timeFrame: Post-study (week 6)
measure: Willingness to Recommend SAGE-LEAF to Other AD Caregivers
timeFrame: Post-study (week 6)
measure: System Usability Scale
timeFrame: Post-study (week 6)
Secondary outcomes:
measure: Zarit Burden Interview
timeFrame: Pre-study and post-study (week 6)
measure: Oberst Caregiving Burden Scale - Time
timeFrame: Pre-study and post-study (week 6)
measure: Oberst Caregiving Burden Scale - Difficulty
timeFrame: Pre-study and post-study (week 6)
measure: Positive Aspects of Caregiving Scale
timeFrame: Pre-study and post-study (week 6)
measure: Role Captivity Sub-scale of Caregiver Reaction Assessment
timeFrame: Pre-study and post-study (week 6)
measure: Overload Sub-scale of Caregiver Reaction Assessment
timeFrame: Pre-study and post-study (week 6)
measure: Caregiving Mastery Subscale of the Caregiving Appraisal Measure
timeFrame: Pre-study and post-study (week 6)
measure: Cohen's Perceived Stress Scale
timeFrame: Pre-study and post-study (week 6)
measure: Positive Affect in Differential Emotions Scale
timeFrame: Pre-study and post-study (week 6)
measure: Negative Affect in Differential Emotions Scale
timeFrame: Pre-study and post-study (week 6)
measure: Patient-Reported Outcomes Measurement Information System - Depression
timeFrame: Pre-study and post-study (week 6)
measure: Patient-Reported Outcomes Measurement Information System - Anxiety
timeFrame: Pre-study and post-study (week 6)
measure: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance
timeFrame: Pre-study and post-study (week 6)
measure: Patient-Reported Outcomes Measurement Information System - Meaning and Purpose
timeFrame: Pre-study and post-study (week 6)
measure: Patient-Reported Outcomes Measurement Information System - Social Isolation
timeFrame: Pre-study and post-study (week 6)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: BrightOutcome
name: DerShung Yang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Judith T Moskowitz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.