SAGE-LEAF: Reducing Burden in Alzheimer's Disease Caregivers Through Positive Emotion Regulation and Virtual Support

Alzheimer Disease Clinical Trial

— SAGE-LEAF  

Official title:

SAGE-LEAF: Reducing Burden in Alzheimer's Disease Caregivers Through Positive Emotion Regulation and Virtual Support

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05562583
• Other study ID #: R43AG065080
• Status: Completed
• Phase: N/A
• Start date: September 30, 2019
• Est. completion date: April 30, 2022

Study information

• Verified date: August 2023
• Source: BrightOutcome
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Behavioral:
• SAGE LEAF
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.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
BrightOutcome	Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Post-study (week 6)
Primary	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.	Post-study (week 6)
Primary	System Usability Scale	This is to measure the usability of SAGE-LEAF. Score range: 0-100. A higher score indicates better usability.	Post-study (week 6)
Secondary	Zarit Burden Interview	Measuring caregiving burden. Score range: 0-88. Higher scores indicate greater burden.	Pre-study and post-study (week 6)
Secondary	Oberst Caregiving Burden Scale - Time	Measuring caregiving burden in terms of time. Score range: 1-5. Higher scores indicate higher levels of caregiver burden.	Pre-study and post-study (week 6)
Secondary	Oberst Caregiving Burden Scale - Difficulty	Measuring caregiving burden in terms of difficulty. Score range: 1-5. Higher scores indicate higher levels of caregiver burden.	Pre-study and post-study (week 6)
Secondary	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.	Pre-study and post-study (week 6)
Secondary	Role Captivity Sub-scale of Caregiver Reaction Assessment	Measuring role captivity in caregiving. Score 1-4. Higher scores indicate stronger feelings of role captivity.	Pre-study and post-study (week 6)
Secondary	Overload Sub-scale of Caregiver Reaction Assessment	Measuring the feeling of overload in caregiving. Score 1-4. Higher scores indicate stronger feelings of overload.	Pre-study and post-study (week 6)
Secondary	Caregiving Mastery Subscale of the Caregiving Appraisal Measure	Measuring caregiving mastery. Score range: 1-5. Higher scores indicate better caregiving mastery.	Pre-study and post-study (week 6)
Secondary	Cohen's Perceived Stress Scale	Measuring perceived stress. Score range: 0-40. Higher scores indicate higher levels of perceived stress	Pre-study and post-study (week 6)
Secondary	Positive Affect in Differential Emotions Scale	Measuring positive emotions. Score range: 1-5. Higher scores indicate higher levels of positive emotions.	Pre-study and post-study (week 6)
Secondary	Negative Affect in Differential Emotions Scale	Measuring positive emotions. Score range: 1-5. Higher scores indicate higher levels of negative emotions.	Pre-study and post-study (week 6)
Secondary	Patient-Reported Outcomes Measurement Information System - Depression	Measuring depression level. Score range: 20-80. Higher scores indicate higher depression levels.	Pre-study and post-study (week 6)
Secondary	Patient-Reported Outcomes Measurement Information System - Anxiety	Measuring anxiety level. Score range: 20-80. Higher scores indicate higher anxiety levels.	Pre-study and post-study (week 6)
Secondary	Patient-Reported Outcomes Measurement Information System - Sleep Disturbance	Measuring sleep disturbance level. Score range: 20-80. Higher scores indicate higher levels of sleep disturbance.	Pre-study and post-study (week 6)
Secondary	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.	Pre-study and post-study (week 6)
Secondary	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.	Pre-study and post-study (week 6)