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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05562583
Acronym
SAGE-LEAF
Enrollment
15
Registered
2022-10-03
Start date
2019-09-30
Completion date
2022-04-30
Last updated
2023-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Keywords

Alzheimer's Disease and Related Dementias, Caregiver

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.

Detailed description

The prevalence of Alzheimer's Disease (AD) and other dementias is steadily climbing and predicted to affect as many as 16 million Americans by 2050. In 2016, 59% of dementia caregivers reported experiencing high levels of emotional and physical stress, and the risk that the chronic stress of dementia caregiving places on caregivers for developing a range of physical and mental health issues is extensively documented. Caregiving-related stress contributes to social isolation, loneliness, and physical illness and increases the risk of caregiver death. Interventions for dementia caregivers have primarily focused on reducing negative emotions and burden. However, over the past few decades, it has become clear that positive emotions are uniquely related to better psychological and physical well-being, independent of the effects of negative emotion suggesting that an intervention that specifically targets positive emotion holds promise for improving caregiver well-being and, ultimately, quality of care for the individual living with AD. The investigators' recent randomized trial of the positive emotion skills intervention, delivered by trained facilitators via the web in N = 170 family caregivers of people with dementia resulted in significant improvements in caregiver psychological well being. However, facilitator-delivered interventions are costly and difficult to implement with fidelity on a large scale. Furthermore, a major challenge to advancing behavioral interventions delivered by trained facilitators is assuring fidelity. The investigators have developed a self-guided online version of the intervention that has shown feasibility and acceptability in several samples, but this version does not capture the critical social connection aspects of the facilitator-delivered intervention. The investigators propose to take the next step toward closing the science-to-practice gap for the positive emotion regulation intervention by tailoring the self-guided online version specifically for dementia caregivers that incorporates the social connection components to combat the loneliness and isolation experienced by many Alzheimer's caregivers. The intervention, called SAGE-LEAF (Social Augmentation of self-Guided Electronic delivery of the Life Enhancing Activities for Family caregivers), leverages the lessons learned from the original LEAF project and adapts its positive emotion intervention to AD caregivers in a self-guided format while incorporating social connection components and adaptive system feedback mechanisms to promote intervention adherence.

Interventions

BEHAVIORALSAGE LEAF

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.

Sponsors

Northwestern University
CollaboratorOTHER
BrightOutcome
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Skill Pages in SAGE-LEAF Accessed by a ParticipantPost-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.
Willingness to Recommend SAGE-LEAF to Other AD CaregiversPost-study (week 6)This is to measure the acceptability of SAGE-LEAF. Score range: 1-10. A higher score indicates higher acceptability.
System Usability ScalePost-study (week 6)This is to measure the usability of SAGE-LEAF. Score range: 0-100. A higher score indicates better usability.

Secondary

MeasureTime frameDescription
Positive Aspects of Caregiving ScalePre-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.
Role Captivity Sub-scale of Caregiver Reaction AssessmentPre-study and post-study (week 6)Measuring role captivity in caregiving. Score 1-4. Higher scores indicate stronger feelings of role captivity.
Overload Sub-scale of Caregiver Reaction AssessmentPre-study and post-study (week 6)Measuring the feeling of overload in caregiving. Score 1-4. Higher scores indicate stronger feelings of overload.
Caregiving Mastery Subscale of the Caregiving Appraisal MeasurePre-study and post-study (week 6)Measuring caregiving mastery. Score range: 1-5. Higher scores indicate better caregiving mastery.
Cohen's Perceived Stress ScalePre-study and post-study (week 6)Measuring perceived stress. Score range: 0-40. Higher scores indicate higher levels of perceived stress
Positive Affect in Differential Emotions ScalePre-study and post-study (week 6)Measuring positive emotions. Score range: 1-5. Higher scores indicate higher levels of positive emotions.
Zarit Burden InterviewPre-study and post-study (week 6)Measuring caregiving burden. Score range: 0-88. Higher scores indicate greater burden.
Patient-Reported Outcomes Measurement Information System - DepressionPre-study and post-study (week 6)Measuring depression level. Score range: 20-80. Higher scores indicate higher depression levels.
Patient-Reported Outcomes Measurement Information System - AnxietyPre-study and post-study (week 6)Measuring anxiety level. Score range: 20-80. Higher scores indicate higher anxiety levels.
Patient-Reported Outcomes Measurement Information System - Sleep DisturbancePre-study and post-study (week 6)Measuring sleep disturbance level. Score range: 20-80. Higher scores indicate higher levels of sleep disturbance.
Patient-Reported Outcomes Measurement Information System - Meaning and PurposePre-study and post-study (week 6)Measuring one's sense of life having purpose and that there are good reasons for living. Score range: 20-80. Higher scores indicate hopefulness, optimism, goal-directedness, and feelings that one's life is worthy.
Patient-Reported Outcomes Measurement Information System - Social IsolationPre-study and post-study (week 6)Measuring perceptions of being avoided, excluded, detached, disconnected from, or unknown by, others. Score range: 20-80. Higher scores indicate higher levels of perception of social isolation.
Negative Affect in Differential Emotions ScalePre-study and post-study (week 6)Measuring positive emotions. Score range: 1-5. Higher scores indicate higher levels of negative emotions.
Oberst Caregiving Burden Scale - TimePre-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.
Oberst Caregiving Burden Scale - DifficultyPre-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.

Countries

United States

Participant flow

Recruitment details

Participants were recruited from a group of individuals who responded to social media advertisements for another caregiver study but were not eligible (3/15, 20%) and from dementia caregiver support groups (12/15, 80%).

Participants by arm

ArmCount
Intervention (Single Arm)
5 session self-guided online delivered positive emotion regulation intervention with social components. SAGE LEAF: 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.
15
Total15

Baseline characteristics

CharacteristicIntervention (Single Arm)
Age, Continuous62.8 years
STANDARD_DEVIATION 11.31
Diagnosis
Frontotemporal dementia
11 Participants
Diagnosis
Uncategorized dementia
4 Participants
Duration of caregiving4.27 years
STANDARD_DEVIATION 2.94
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
13 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
15 Participants
Sex: Female, Male
Female
11 Participants
Sex: Female, Male
Male
4 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 15
other
Total, other adverse events
0 / 15
serious
Total, serious adverse events
0 / 15

Outcome results

Primary

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.

Time frame: Post-study (week 6)

ArmMeasureValue (MEAN)Dispersion
Intervention (Single Arm)Percentage of Skill Pages in SAGE-LEAF Accessed by a Participant72 Percentage of skill pagesStandard Deviation 42
Primary

System Usability Scale

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

Time frame: Post-study (week 6)

ArmMeasureValue (MEDIAN)
Intervention (Single Arm)System Usability Scale73.75 score on a scale
Primary

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.

Time frame: Post-study (week 6)

ArmMeasureValue (MEDIAN)
Intervention (Single Arm)Willingness to Recommend SAGE-LEAF to Other AD Caregivers8 score on a scale
Secondary

Caregiving Mastery Subscale of the Caregiving Appraisal Measure

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

Time frame: Pre-study and post-study (week 6)

ArmMeasureValue (MEAN)Dispersion
Intervention (Single Arm)Caregiving Mastery Subscale of the Caregiving Appraisal Measure2.66 score on a scaleStandard Deviation 0.45
Secondary

Cohen's Perceived Stress Scale

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

Time frame: Pre-study and post-study (week 6)

ArmMeasureValue (MEAN)Dispersion
Intervention (Single Arm)Cohen's Perceived Stress Scale7.5 score on a scaleStandard Deviation 1.78
Secondary

Negative Affect in Differential Emotions Scale

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

Time frame: Pre-study and post-study (week 6)

ArmMeasureValue (MEAN)Dispersion
Intervention (Single Arm)Negative Affect in Differential Emotions Scale1.34 score on a scaleStandard Deviation 0.72
Secondary

Oberst Caregiving Burden Scale - Difficulty

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

Time frame: Pre-study and post-study (week 6)

ArmMeasureValue (MEAN)Dispersion
Intervention (Single Arm)Oberst Caregiving Burden Scale - Difficulty2.77 score on a scaleStandard Deviation 0.82
Secondary

Oberst Caregiving Burden Scale - Time

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

Time frame: Pre-study and post-study (week 6)

ArmMeasureValue (MEAN)Dispersion
Intervention (Single Arm)Oberst Caregiving Burden Scale - Time3.07 score on a scaleStandard Deviation 0.75
Secondary

Overload Sub-scale of Caregiver Reaction Assessment

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

Time frame: Pre-study and post-study (week 6)

ArmMeasureValue (MEAN)Dispersion
Intervention (Single Arm)Overload Sub-scale of Caregiver Reaction Assessment2.65 score on a scaleStandard Deviation 0.83
Secondary

Patient-Reported Outcomes Measurement Information System - Anxiety

Measuring anxiety level. Score range: 20-80. Higher scores indicate higher anxiety levels.

Time frame: Pre-study and post-study (week 6)

ArmMeasureValue (MEAN)Dispersion
Intervention (Single Arm)Patient-Reported Outcomes Measurement Information System - Anxiety57.45 score on a scaleStandard Deviation 7.96
Secondary

Patient-Reported Outcomes Measurement Information System - Depression

Measuring depression level. Score range: 20-80. Higher scores indicate higher depression levels.

Time frame: Pre-study and post-study (week 6)

ArmMeasureValue (MEAN)Dispersion
Intervention (Single Arm)Patient-Reported Outcomes Measurement Information System - Depression57.96 score on a scaleStandard Deviation 5.05
Secondary

Patient-Reported Outcomes Measurement Information System - Meaning and Purpose

Measuring one's sense of life having purpose and that there are good reasons for living. Score range: 20-80. Higher scores indicate hopefulness, optimism, goal-directedness, and feelings that one's life is worthy.

Time frame: Pre-study and post-study (week 6)

ArmMeasureValue (MEAN)Dispersion
Intervention (Single Arm)Patient-Reported Outcomes Measurement Information System - Meaning and Purpose47.19 score on a scaleStandard Deviation 5.63
Secondary

Patient-Reported Outcomes Measurement Information System - Sleep Disturbance

Measuring sleep disturbance level. Score range: 20-80. Higher scores indicate higher levels of sleep disturbance.

Time frame: Pre-study and post-study (week 6)

ArmMeasureValue (MEAN)Dispersion
Intervention (Single Arm)Patient-Reported Outcomes Measurement Information System - Sleep Disturbance52.73 score on a scaleStandard Deviation 7.27
Secondary

Patient-Reported Outcomes Measurement Information System - Social Isolation

Measuring perceptions of being avoided, excluded, detached, disconnected from, or unknown by, others. Score range: 20-80. Higher scores indicate higher levels of perception of social isolation.

Time frame: Pre-study and post-study (week 6)

ArmMeasureValue (MEAN)Dispersion
Intervention (Single Arm)Patient-Reported Outcomes Measurement Information System - Social Isolation51.27 score on a scaleStandard Deviation 5.73
Secondary

Positive Affect in Differential Emotions Scale

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

Time frame: Pre-study and post-study (week 6)

ArmMeasureValue (MEAN)Dispersion
Intervention (Single Arm)Positive Affect in Differential Emotions Scale1.82 score on a scaleStandard Deviation 0.68
Secondary

Positive Aspects of Caregiving Scale

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

Time frame: Pre-study and post-study (week 6)

ArmMeasureValue (MEAN)Dispersion
Intervention (Single Arm)Positive Aspects of Caregiving Scale22.23 score on a scaleStandard Deviation 9.27
Secondary

Role Captivity Sub-scale of Caregiver Reaction Assessment

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

Time frame: Pre-study and post-study (week 6)

ArmMeasureValue (MEAN)Dispersion
Intervention (Single Arm)Role Captivity Sub-scale of Caregiver Reaction Assessment2.55 score on a scaleStandard Deviation 0.7
Secondary

Zarit Burden Interview

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

Time frame: Pre-study and post-study (week 6)

ArmMeasureValue (MEAN)Dispersion
Intervention (Single Arm)Zarit Burden Interview15.67 score on a scaleStandard Deviation 3.54

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026