Online Program for Dementia Caregiver Burden

(SAGE LEAF 2 Trial)

Overseen By Caroline Leong

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Care recipient in facility, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

140 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn if the SAGE LEAF (Social Augmentation of self-Guided Electronic delivery of the Life Enhancing Activities for Family caregivers) online positive emotion skill-building program delivered through Caregiver Serving Organizations can help family caregivers of individuals with dementia cope with stress. The main questions it aims to answer are: * How does SAGE LEAF affect positive emotion, caregiver burden, loneliness, and depression for family caregivers? * What are the challenges and successes when rolling out an online program in partnership with Caregiver Serving Organizations? Participants will complete the 8-week online SAGE LEAF intervention as well as two survey assessments, one before the intervention and one after.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment SAGE LEAF Positive Emotion Skills Course for reducing caregiver burden in dementia?

Research shows that interventions focusing on positive emotions can help caregivers of people with dementia by improving their well-being, coping skills, and mental health. A study on a similar positive affect skills intervention found it could enhance caregivers' quality of life and reduce stress. ^{1 2 3 4 5}

Is the Online Program for Dementia Caregiver Burden safe for humans?

The studies reviewed do not provide specific safety data for the Online Program for Dementia Caregiver Burden, but they suggest that similar interventions, like resourcefulness training and behavioral activation, are generally acceptable and feasible for caregivers, indicating they are likely safe. ^{1 2 4 6 7}

How is the SAGE LEAF Positive Emotion Skills Course different from other treatments for dementia caregiver burden?

The SAGE LEAF Positive Emotion Skills Course is unique because it is an online program specifically designed to teach positive emotion skills to caregivers, which can help them manage stress and improve their emotional well-being. Unlike traditional in-person workshops or psychoeducational interventions, this course offers the flexibility and accessibility of online learning, making it easier for caregivers to participate at their convenience. ^{5 8 9 10 11}

Research Team

Judith Moskowitz, Ph.D.

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for family caregivers of individuals with dementia. Participants should be experiencing stress related to their caregiving responsibilities and must have access to the internet to complete an 8-week online program. The study aims to help them cope better.

Inclusion Criteria

* Identifies as primary family caregiver of someone with Alzheimer's disease

* Speak and read English

* Has access to high speed internet and wi-fi enabled device

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete the 8-week online SAGE LEAF intervention, involving weekly self-guided positive emotion skill lessons, daily skill practice exercises, and daily emotion reporting.

8 weeks

Follow-up

Participants are monitored for changes in positive emotion, caregiver burden, loneliness, and depression after the intervention.

4 weeks

Treatment Details

Interventions

• SAGE LEAF Positive Emotion Skills Course

Trial Overview The SAGE LEAF online course is being tested for its effectiveness in reducing caregiver burden and improving positive emotions, loneliness, and depression among dementia caregivers through a self-guided program delivered by Caregiver Serving Organizations.

Participant Groups

Group I: Experimental: Positive emotion skills intervention Experimental Treatment 1 Intervention

Participants will go through a 6-week positive emotion skills course where 1 new skill lesson opens each week.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

BrightOutcome, Inc.

Collaborator

Trials

4

Recruited

240+

BrightOutcome

Industry Sponsor

Trials

7

Recruited

610+

Findings from Research

A systematic review of 24 studies on dyadic psychoeducational support programs for people with dementia and their caregivers found that tailored, goal-oriented programs significantly improve various aspects of health and quality of life for both parties.

The review highlights the importance of long-term, individualized support programs to address the progressive needs of individuals with dementia and their caregivers, suggesting that such interventions can lead to sustained positive outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of dyadic psychoeducational programs for persons with dementia and their family caregivers. Ghosh, M., Dunham, M., O'Connell, B.[2023]

The dementia Carer Education Programme increased carers' knowledge about dementia but did not significantly improve their quality of life, burden, or well-being after six months, based on a study of 32 carers.

Carers who reported a worsening situation post-programme experienced poorer quality of life and increased burden, highlighting that patient behavior disturbance was a key factor affecting their experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dementia carer education and patient behaviour disturbance. Coen, RF., O'Boyle, CA., Coakley, D., et al.[2006]

A systematic review of 19 studies found that online dementia training programs significantly improve the preparedness and condition of both formal and informal caregivers, addressing the growing need for skilled dementia care as Alzheimer's disease rates rise.

Future research should focus on enhancing study designs by incorporating multiple time points, control groups, and personalized, interactive content to better evaluate the effectiveness of these online training programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of online dementia caregivers training programs: A systematic review. Pleasant, M., Molinari, V., Dobbs, D., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Systematic review of dyadic psychoeducational programs for persons with dementia and their family caregivers. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Dementia carer education and patient behaviour disturbance. [2006]

3. United States pubmed.ncbi.nlm.nih.gov

Change in indices of distress among Latino and Anglo female caregivers of elderly relatives with dementia: site-specific results from the REACH national collaborative study. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Life Enhancing Activities for Family Caregivers of people with dementia: protocol for a randomized controlled trial of a positive affect skills intervention. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

"Easing the way" for spouse caregivers of individuals with dementia: a pilot feasibility study of a grief intervention. [2010]

6. England pubmed.ncbi.nlm.nih.gov

Resourcefulness Training for Women Dementia Caregivers: Acceptability and Feasibility of Two Methods. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Telephone-Based Behavioral Activation for Improving Sleep Quality in Family Caregivers of People With Dementia: A Pilot Randomized Controlled Trial. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Caregiver Burden: Caregiving Workshops Have a Positive Impact on Those Caring for Individuals With Dementia in Arkansas. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

"Coping with frustration" classes: development and preliminary outcomes with women who care for relatives with dementia. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of a psychoeducational intervention group program in the reduction of the burden experienced by caregivers of patients with dementia: the EDUCA-II randomized trial. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of online dementia caregivers training programs: A systematic review. [2021]