Alzheimer DiseaseSAGE-LEAFNCT05562583
SAGE-LEAF: Reducing Burden in Alzheimer's Disease Caregivers Through Positive Emotion Regulation and Virtual Support
A study testing SAGE LEAF in people with Alzheimer Disease, run by BrightOutcome at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- SAGE LEAF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2019to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Alzheimer Disease
- Being tested
- SAGE LEAF
- Keywords
- Alzheimer's Disease and Related Dementias, Caregiver
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAGE LEAFBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (single arm) | Experimental | 5 session self-guided online delivered positive emotion regulation intervention with social components. Receives: Behavioral: SAGE LEAF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Post-study (week 6)
Secondary outcomes (15)
Zarit Burden Interview
Measuring caregiving burden. Score range: 0-88. Higher scores indicate greater burden.
Measured: Pre-study and post-study (week 6)
Oberst Caregiving Burden Scale - Time
Measuring caregiving burden in terms of time. Score range: 1-5. Higher scores indicate higher levels of caregiver burden.
Measured: Pre-study and post-study (week 6)
Oberst Caregiving Burden Scale - Difficulty
Measuring caregiving burden in terms of difficulty. Score range: 1-5. Higher scores indicate higher levels of caregiver burden.
Measured: Pre-study and post-study (week 6)
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.
Measured: Pre-study and post-study (week 6)
Role Captivity Sub-scale of Caregiver Reaction Assessment
Measuring role captivity in caregiving. Score 1-4. Higher scores indicate stronger feelings of role captivity.
Measured: Pre-study and post-study (week 6)
Overload Sub-scale of Caregiver Reaction Assessment
Measuring the feeling of overload in caregiving. Score 1-4. Higher scores indicate stronger feelings of overload.
Measured: Pre-study and post-study (week 6)
Caregiving Mastery Subscale of the Caregiving Appraisal Measure
Measuring caregiving mastery. Score range: 1-5. Higher scores indicate better caregiving mastery.
Measured: Pre-study and post-study (week 6)
Cohen's Perceived Stress Scale
Measuring perceived stress. Score range: 0-40. Higher scores indicate higher levels of perceived stress
Measured: Pre-study and post-study (week 6)
Positive Affect in Differential Emotions Scale
Measuring positive emotions. Score range: 1-5. Higher scores indicate higher levels of positive emotions.
Measured: Pre-study and post-study (week 6)
Negative Affect in Differential Emotions Scale
Measuring positive emotions. Score range: 1-5. Higher scores indicate higher levels of negative emotions.
Measured: Pre-study and post-study (week 6)
Patient-Reported Outcomes Measurement Information System - Depression
Measuring depression level. Score range: 20-80. Higher scores indicate higher depression levels.
Measured: Pre-study and post-study (week 6)
Patient-Reported Outcomes Measurement Information System - Anxiety
Measuring anxiety level. Score range: 20-80. Higher scores indicate higher anxiety levels.
Measured: Pre-study and post-study (week 6)
Patient-Reported Outcomes Measurement Information System - Sleep Disturbance
Measuring sleep disturbance level. Score range: 20-80. Higher scores indicate higher levels of sleep disturbance.
Measured: Pre-study and post-study (week 6)
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.
Measured: Pre-study and post-study (week 6)
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.
Measured: Pre-study and post-study (week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start30 Sep 2019
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- BrightOutcome
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Northwestern University
- Responsible party
- Principal investigator, DerShung Yang, PhD, BrightOutcome
- Investigators
- DerShung Yang, PhD, Principal investigator, BrightOutcomeJudith T Moskowitz, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562583
- Sponsor's protocol ID
- R43AG065080
- Acronym
- SAGE-LEAF
- Status last verified
- Aug 2023
- First submitted
- 18 Sep 2022
- Last updated
- 24 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37672311
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAGE-LEAF: Reducing Burden in Alzheimer's Disease Caregivers Through Positive Emotion Regulation and Virtual Support
- ClinicalTrials.gov ID
- NCT05562583
- Acronym / sponsor ID
- SAGE-LEAF / R43AG065080
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer's Disease and Related Dementias, Caregiver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- BrightOutcomeIndustry (pharma, biotech, devices)
- Collaborators
- Northwestern University
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 3 Oct 2022 (actual)
- Results
- Posted 24 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention (single arm) | Experimental | Behavioral: SAGE LEAF5 session self-guided online delivered positive emotion regulation intervention with social components. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAGE LEAFSAGE 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. | Behavioural | Intervention (single arm) |
Primary outcome
Percentage of Skill Pages in SAGE-LEAF Accessed by a Participant
Time frame: 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.
Willingness to Recommend SAGE-LEAF to Other AD Caregivers
Time frame: Post-study (week 6)
This is to measure the acceptability of SAGE-LEAF. Score range: 1-10. A higher score indicates higher acceptability.
System Usability Scale
Time frame: Post-study (week 6)
This is to measure the usability of SAGE-LEAF. Score range: 0-100. A higher score indicates better usability.
15 secondary outcomes
Zarit Burden Interview
Time frame: Pre-study and post-study (week 6)
Oberst Caregiving Burden Scale - Time
Time frame: Pre-study and post-study (week 6)
Oberst Caregiving Burden Scale - Difficulty
Time frame: Pre-study and post-study (week 6)
Positive Aspects of Caregiving Scale
Time frame: Pre-study and post-study (week 6)
Role Captivity Sub-scale of Caregiver Reaction Assessment
Time frame: Pre-study and post-study (week 6)
Overload Sub-scale of Caregiver Reaction Assessment
Time frame: Pre-study and post-study (week 6)
Caregiving Mastery Subscale of the Caregiving Appraisal Measure
Time frame: Pre-study and post-study (week 6)
Cohen's Perceived Stress Scale
Time frame: Pre-study and post-study (week 6)
Positive Affect in Differential Emotions Scale
Time frame: Pre-study and post-study (week 6)
Negative Affect in Differential Emotions Scale
Time frame: Pre-study and post-study (week 6)
Patient-Reported Outcomes Measurement Information System - Depression
Time frame: Pre-study and post-study (week 6)
Patient-Reported Outcomes Measurement Information System - Anxiety
Time frame: Pre-study and post-study (week 6)
Patient-Reported Outcomes Measurement Information System - Sleep Disturbance
Time frame: Pre-study and post-study (week 6)
Patient-Reported Outcomes Measurement Information System - Meaning and Purpose
Time frame: Pre-study and post-study (week 6)
Patient-Reported Outcomes Measurement Information System - Social Isolation
Time frame: Pre-study and post-study (week 6)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 37672311Kwok 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DerShung Yang, PhD principal investigator
BrightOutcome
Judith T Moskowitz, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAGE LEAF in people with Alzheimer Disease, run by BrightOutcome at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Skill Pages in SAGE-LEAF Accessed by a Participant (time frame: Post-study (week 6)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05562583, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023.