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NCT06708182 | NOT YET RECRUITING | Caregiving Stress


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

Northwestern University

Information provided by (Responsible Party):

Judith Moskowitz

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.

Condition or disease

Caregiving Stress

Caregiver Burden

Intervention/treatment

SAGE LEAF Positive Emotion Skills Course

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 140 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
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
Actual Study Start Date : 2025-06
Estimated Primary Completion Date : 2026-06
Estimated Study Completion Date : 2026-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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

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

Location Details

NCT06708182


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Locations


Not yet recruiting

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60611

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