Clinical trial NCT06708182: SAGE LEAF 2: An Online Program to Reduce Dementia Caregiver Burden
Official title: Social Augmentation of Self-Guided Electronic Delivery of the Life Enhancing Activities for Family Caregivers (SAGE LEAF 2): An Online Self-Guided Positive Emotion Regulation Program to Reduce Alzheimer's Dementia Caregiver Burden Delivered Through Caregiver-Serving Organizations
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Caregiving Stress
Caregiver Burden
Keywords: Caregiving
Alzheimer's disease
Positive Emotion
Psychological well-being
Dementia
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: BrightOutcome
First posted: 2024-11-27
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to learn if the SAGE LEAF (Social Augmentation of self-Guided Electronic delivery of the Life Enhancing Activities for Family caregivers) online positive emotion skill-building program delivered through Caregiver Serving Organizations can help family caregivers of individuals with dementia cope with stress. The main questions it aims to answer are:

* How does SAGE LEAF affect positive emotion, caregiver burden, loneliness, and depression for family caregivers?
* What are the challenges and successes when rolling out an online program in partnership with Caregiver Serving Organizations? Participants will complete the 8-week online SAGE LEAF intervention as well as two survey assessments, one before the intervention and one after.

Detailed description: The SAGE LEAF 2 study is a single-arm fully online implementation trial of the SAGE LEAF program delivered to family caregivers through Caregiver Serving Organizations (CSOs). The SAGE LEAF intervention is 8 weeks long and involves weekly self-guided positive emotion skill lessons, daily skill practice exercises, and daily emotion reporting, all housed on the SAGE LEAF website. The website also includes social features, such as a discussion board and profile pages, to facilitate social connection among participants. Up to n=140 family caregivers of individuals with dementia will be recruited through CSOs and the general population. To participate, caregivers must (1) identify as the primary family caregiver of a person with Alzheimer's disease, (2) be at least 18 years old, (3) speak and read English, and (4) have access to high-speed internet. Participants will complete survey assessments via REDCap before and after they go through the SAGE LEAF intervention. All study activities will take place online.

Individual level effectiveness will be assessed using self-reported outcomes, such as positive affect, caregiver burden, loneliness, and depression. These outcomes will be measured both pre- and post-intervention. Implementation barriers and facilitators will be assessed using follow-up qualitative interviews.

Eligibility criteria: Inclusion Criteria:

* Identifies as primary family caregiver of someone with Alzheimer's disease
* Speak and read English
* Has access to high speed internet and wi-fi enabled device

Exclusion Criteria:

* Care recipient lives in care facility
* Does not speak/read English
* Does not have access to internet
* Care recipient does not have Alzheimer's disease

Primary outcomes:
measure: Caregiver Burden measured using the Zarit Burden Interview.
timeFrame: Baseline and 8 weeks
measure: Positive Aspects of Caregiving measured using the Positive Aspects of Caregiving scale
timeFrame: Baseline and 8 weeks
measure: Positive Affect measured using the PROMIS Bank v1.0 Positive Affect
timeFrame: Baseline and 8 weeks
measure: Caregiver self-efficacy/mastery measured using the Caregiving Mastery subscale of the Caregiving Appraisal Measure
timeFrame: Baseline and 8 weeks
measure: Anxiety measured by PROMIS Bank v1.0 Anxiety
timeFrame: Baseline and 8 weeks
measure: Depression measured by PROMIS Bank v1.0 Depression
timeFrame: Baseline and 8 weeks
measure: Social isolation measured by PROMIS Bank v2.0 Social Isolation
timeFrame: Baseline and 8 weeks
measure: Self-efficacy measured by PROMIS Bank v1.0 General Self-Efficacy
timeFrame: Baseline and 8 weeks
measure: Life satisfaction measured by PROMIS Bank v1.0 General Life Satisfaction
timeFrame: Baseline and 8 weeks
measure: Perceived stress measured by Cohen's Perceived Stress Scale
timeFrame: Baseline and 8 weeks
measure: Perceived social support measured by the Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: Baseline and 8 weeks
measure: Meaning and Purpose measured using PROMIS Bank v1.0 Meaning and Purpose
timeFrame: Baseline and 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Judith Moskowitz, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: