NCT05562583: SAGE-LEAF

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

Completed NA Results posted Last updated 24 October 2023

What this trial tests

NA trial testing SAGE LEAF in Alzheimer Disease in 15 participants. Completed in 30 April 2022.

Timeline

30 September 2019

Primary endpoint
30 April 2022

30 April 2022

Quick facts

Lead sponsor	BrightOutcome
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	15
Start date	30 September 2019
Primary completion	30 April 2022
Estimated completion	30 April 2022
Sites	1 location across United States

Drugs / interventions tested

• SAGE LEAF

Conditions studied

• Alzheimer Disease — all drugs for Alzheimer Disease →

Sponsor

BrightOutcome

Who can join

Adults 18 to 90, any sex, with Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Skill Pages in SAGE-LEAF Accessed by a Participant Primary · Post-study (week 6)

This is to measure adherence to SAGE-LEAF intervention. Score range: 0-100%. A higher percentage means better adherence to the SAGE-LEAF intervention.

Group	Value	95% CI
Intervention (Single Arm)	72	± 42

Willingness to Recommend SAGE-LEAF to Other AD Caregivers Primary · Post-study (week 6)

This is to measure the acceptability of SAGE-LEAF. Score range: 1-10. A higher score indicates higher acceptability.

Group	Value	95% CI
Intervention (Single Arm)	8	6.25 – 9.5

System Usability Scale Primary · Post-study (week 6)

This is to measure the usability of SAGE-LEAF. Score range: 0-100. A higher score indicates better usability.

Group	Value	95% CI
Intervention (Single Arm)	73.75	57.5 – 85.63

Zarit Burden Interview Secondary · Pre-study and post-study (week 6)

Measuring caregiving burden. Score range: 0-88. Higher scores indicate greater burden.

Group	Value	95% CI
Intervention (Single Arm)	15.67	± 3.54

Oberst Caregiving Burden Scale - Time Secondary · Pre-study and post-study (week 6)

Measuring caregiving burden in terms of time. Score range: 1-5. Higher scores indicate higher levels of caregiver burden.

Group	Value	95% CI
Intervention (Single Arm)	3.07	± 0.75

Oberst Caregiving Burden Scale - Difficulty Secondary · Pre-study and post-study (week 6)

Measuring caregiving burden in terms of difficulty. Score range: 1-5. Higher scores indicate higher levels of caregiver burden.

Group	Value	95% CI
Intervention (Single Arm)	2.77	± 0.82

Positive Aspects of Caregiving Scale Secondary · Pre-study and post-study (week 6)

Measuring positive aspects to caregiving for dementia patients. Score range: 5-45. Higher scores indicate better caregivers' outlook on life and self-affirmations.

Group	Value	95% CI
Intervention (Single Arm)	22.23	± 9.27

Role Captivity Sub-scale of Caregiver Reaction Assessment Secondary · Pre-study and post-study (week 6)

Measuring role captivity in caregiving. Score 1-4. Higher scores indicate stronger feelings of role captivity.

Group	Value	95% CI
Intervention (Single Arm)	2.55	± 0.7

Overload Sub-scale of Caregiver Reaction Assessment Secondary · Pre-study and post-study (week 6)

Measuring the feeling of overload in caregiving. Score 1-4. Higher scores indicate stronger feelings of overload.

Group	Value	95% CI
Intervention (Single Arm)	2.65	± 0.83

Caregiving Mastery Subscale of the Caregiving Appraisal Measure Secondary · Pre-study and post-study (week 6)

Measuring caregiving mastery. Score range: 1-5. Higher scores indicate better caregiving mastery.

Group	Value	95% CI
Intervention (Single Arm)	2.66	± 0.45

Cohen's Perceived Stress Scale Secondary · Pre-study and post-study (week 6)

Measuring perceived stress. Score range: 0-40. Higher scores indicate higher levels of perceived stress

Group	Value	95% CI
Intervention (Single Arm)	7.5	± 1.78

Positive Affect in Differential Emotions Scale Secondary · Pre-study and post-study (week 6)

Measuring positive emotions. Score range: 1-5. Higher scores indicate higher levels of positive emotions.

Group	Value	95% CI
Intervention (Single Arm)	1.82	± 0.68

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.