SAGE LEAF 2: An Online Program to Reduce Dementia Caregiver Burden

Northwestern University

Status: Enrolling

Conditions: Caregiver Burden; Caregiving Stress

Treatments: Behavioral: SAGE LEAF Positive Emotion Skills Course

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT06708182

2R44AG065080-03 (U.S. NIH Grant/Contract)

STU00222543

Details and patient eligibility

About

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.

Full 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 dementia, (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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Identifies as primary family caregiver of someone with dementia
• 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

140 participants in 1 patient group

Experimental: Positive emotion skills intervention

Experimental group

Description:

Participants will go through a 6-week positive emotion skills course where 1 new skill lesson opens each week.

Treatment:

Behavioral: SAGE LEAF Positive Emotion Skills Course