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

NCT05562583 | Completed Results

• 1 other identifier: R43AG065080
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Keywords

Alzheimer's Disease and Related Dementias; Caregiver

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (15)

• Zarit Burden Interview

  Pre-study and post-study (week 6)

• Oberst Caregiving Burden Scale - Time

  Pre-study and post-study (week 6)

• Oberst Caregiving Burden Scale - Difficulty

  Pre-study and post-study (week 6)

• Positive Aspects of Caregiving Scale

  Pre-study and post-study (week 6)

• Role Captivity Sub-scale of Caregiver Reaction Assessment

  Pre-study and post-study (week 6)

Study Arms (1)

Intervention (single arm)

EXPERIMENTAL

5 session self-guided online delivered positive emotion regulation intervention with social components.

Behavioral: SAGE LEAF

Interventions

SAGE LEAF BEHAVIORAL

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.

Intervention (single arm)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• BrightOutcome: lead
• Northwestern University: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related 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.

  PMID: 37672311 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Judith Tedlie Moskowitz
• Organization: Northwestern University

judith.moskowitz@northwestern.edu

312-503-7712

Study Officials

• DerShung Yang, PhD

  BrightOutcome

  PRINCIPAL INVESTIGATOR

• Judith T Moskowitz, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: September 18, 2022
• First Posted: October 3, 2022
• Study Start: September 30, 2019
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: October 24, 2023
• Results First Posted: October 24, 2023

Record last verified: 2023-08

Locations

US (1)