N/A
Completed N=15
SAGE-LEAF: Reducing Burden in Alzheimer's Disease Caregivers Through Positive Emotion Regulation and Virtual Support
Source: ClinicalTrials.gov NCT05562583 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcomePrimary: Percentage of Skill Pages in SAGE-LEAF Accessed by a Participant — 72 Percentage of skill pages
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Skill Pages in SAGE-LEAF Accessed by a Participant |
72 | — |
| PRIMARY Willingness to Recommend SAGE-LEAF to Other AD Caregivers |
8 | — |
| PRIMARY System Usability Scale |
73.75 | — |
| SECONDARY Zarit Burden Interview |
15.67 | — |
| SECONDARY Oberst Caregiving Burden Scale - Time |
3.07 | — |
| SECONDARY Oberst Caregiving Burden Scale - Difficulty |
2.77 | — |
| SECONDARY Positive Aspects of Caregiving Scale |
22.23 | — |
| SECONDARY Role Captivity Sub-scale of Caregiver Reaction Assessment |
2.55 | — |
| SECONDARY Overload Sub-scale of Caregiver Reaction Assessment |
2.65 | — |
| SECONDARY Caregiving Mastery Subscale of the Caregiving Appraisal Measure |
2.66 | — |
| SECONDARY Cohen's Perceived Stress Scale |
7.5 | — |
| SECONDARY Positive Affect in Differential Emotions Scale |
1.82 | — |
| SECONDARY Negative Affect in Differential Emotions Scale |
1.34 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System - Depression |
57.96 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System - Anxiety |
57.45 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System - Sleep Disturbance |
52.73 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System - Meaning and Purpose |
47.19 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System - Social Isolation |
51.27 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05562583). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.