Online Support Program for Dementia Caregivers

(STELLA-R Trial)

Overseen By Christina Zonker, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Disqualifiers: Severe vision problems, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

Duration: 8 weeks

238 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online program called the STELLA-R Curriculum, designed to help caregivers manage the challenging behaviors of loved ones with dementia. The goal is to ease these situations for caregivers and reduce their stress. Participants will either start the program immediately or wait eight weeks to begin. This trial suits adults in Oregon, Washington, or Idaho who care for a family member with dementia and find certain behaviors particularly stressful. As an unphased trial, it offers caregivers the opportunity to access new resources that may enhance their caregiving experience.

Do I need to stop my current medications to join the trial?

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

What prior data suggests that this online intervention is safe for dementia caregivers?

Research shows that the STELLA-R Curriculum is safe for participants. This program is an online tool that helps caregivers manage symptoms in people with dementia. The STELLA-FTD Pilot Study found that such programs are easy to use and reduce caregiver stress. No evidence indicates any harmful effects from using the program. As an educational tool, it is unlikely to cause physical harm. Overall, current evidence suggests that users receive the STELLA-R Curriculum well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the STELLA-R Curriculum because it offers a fresh approach to supporting dementia caregivers. Unlike traditional caregiver support methods, such as in-person therapy sessions or support groups, STELLA-R is delivered entirely online, providing flexibility and accessibility for caregivers who may have demanding schedules. This digital format allows caregivers to access resources and support anytime, anywhere, which is particularly beneficial for those who may struggle to attend regular in-person meetings. By potentially reducing caregiver stress and improving their overall well-being, STELLA-R aims to enhance the quality of care provided to individuals with dementia, making it a promising development in caregiver support.

What evidence suggests that the STELLA-R Curriculum is effective for managing dementia-related symptoms?

Studies have shown that the STELLA-R Curriculum can help manage behavior and mood issues in people with dementia. In this trial, participants in the Experimental Group will start the STELLA-R Curriculum immediately after enrollment, while those in the Waitlist Control Group will begin 8 weeks later. Research indicates that similar programs, like STELLA-FTD and Tele-STELLA, are practical and well-received by caregivers. These programs may help reduce the stress and challenges of caring for someone with dementia. They teach caregivers how to better understand and respond to difficult behaviors, making caregiving less stressful. Overall, these early findings suggest that the STELLA-R Curriculum might effectively support those caring for people with dementia. ^{1 2 3 6 7}

Who Is on the Research Team?

Allison Lindauer, PhD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for adult caregivers in Oregon, Washington, or Idaho who look after a family member with dementia and find at least two behavioral symptoms distressing. Participants must speak English, have a phone, email, and mailing address to receive materials.

Inclusion Criteria

Speaks and understands English to be able to participate in intervention

Owns a telephone (smartphone, cell phone or landline)

I am an adult caring for a family member with Alzheimer's or related dementia.

Exclusion Criteria

I am willing and able to follow study instructions and procedures.

My vision problems are severe and may stop me from joining.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment

Initial assessments including the Pittsburgh Sleep Quality Index and other baseline measures

1 week

1 visit (virtual)

Treatment

Care partners start the STELLA-R Curriculum, focusing on the ABC approach to manage behavioral symptoms

8 weeks

Weekly online sessions

Follow-up

Participants are monitored for the effectiveness of the intervention and complete various assessments

16 weeks

Assessments at weeks 8, 16, and 24

Waitlist Control

Care partners in the waitlist control group start the STELLA-R Curriculum after an 8-week delay

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• STELLA-R Curriculum

Trial Overview The STELLA-R online curriculum is being tested. It's designed to help caregivers manage difficult behaviors in dementia using the ABC approach—a technique that focuses on understanding behavior triggers and consequences.

How Is the Trial Designed?

Group I: Experimental Group Experimental Treatment 3 Interventions

Care partners start the STELLA-R Curriculum immediately after enrollment.

Group II: Waitlist Control Group Active Control 3 Interventions

Care partners start the STELLA-R Curriculum 8 weeks after enrollment.

STELLA-R Curriculum is already approved in United States for the following indications:

Approved in United States as STELLA-R for:

• Management of behavioral and psychological symptoms in dementia care

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

The Hart Family Foundation

Collaborator

Trials

1

Recruited

240+

Published Research Related to This Trial

Internet interventions can improve the well-being of informal caregivers for dementia patients, enhancing aspects like confidence, depression, and self-efficacy, especially when tailored to individual needs and including multiple components.

Despite showing potential benefits, the overall quality of evidence from the studies is low, indicating a need for more rigorous randomized controlled trials to better assess the effectiveness of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of Internet-based supportive interventions for caregivers of patients with dementia. Boots, LM., de Vugt, ME., van Knippenberg, RJ., et al.[2022]

The IHSS + ADRD Training Project is a 10-week online training program designed to improve dementia care knowledge among IHSS caregivers in Alameda County.

Preliminary results show that caregivers who completed the training experienced significant increases in their knowledge about dementia and their confidence in providing care, highlighting the need for ongoing training initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Dementia Knowledge and Self-Efficacy of In-Home Supportive Services Caregivers Through Online Training. Yeh, J., Pond, B., Beld, M., et al.[2023]

A qualitative study involving 36 caregivers of individuals with dementia explored their experiences with an online psychoeducational program called Tele-Savvy, highlighting its potential to overcome logistical barriers of in-person training.

Caregivers identified key areas for improvement, including enhancing rapport with instructors, diversifying content, and refining the program's structure, which can inform the development of future online caregiver training interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Online Program for Caregivers of Persons Living With Dementia: Lessons Learned. Kovaleva, M., Blevins, L., Griffiths, PC., et al.[2022]

The Tele-Savvy Caregiver Program, a 43-day online intervention, was well-accepted by caregivers of persons living with dementia, enhancing their understanding of dementia and caregiving responsibilities.

Caregivers provided valuable feedback on their needs post-hospital discharge, which will inform the development of future transitional care interventions tailored to support them effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caregivers' experience with Tele-Savvy Caregiver Program post-hospitalization. Kovaleva, MA., Kleinpell, R., Dietrich, MS., et al.[2023]

A serious game called 'SafeHome' was developed to educate caregivers on safety strategies for persons living with dementia, helping them identify and fix potential hazards at home, which can improve outcomes for both caregivers and patients.

In a usability study with 13 participants, 80% expressed satisfaction with the game, and all provided feedback for improvements, indicating a positive reception and potential for enhancing caregiver education through innovative e-learning resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SafeHome: A Serious Game to Promote Safe Environments for Persons Living with Dementia. Appel, L., Peisachovich, E., Sinclair, D., et al.[2020]

The Alzheimer's Caregiver Support Online program was developed to provide education and support for family caregivers of older adults with progressive dementia, addressing their emotional and behavioral challenges.

Initial evaluations of the program indicate that it offers valuable resources and training, which are crucial since most caregivers currently lack formal instruction on managing the complexities of dementia care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alzheimer's Caregiver Support Online: lessons learned, initial findings and future directions. Glueckauf, RL., Loomis, JS.[2022]

The psychoeducational program 'Living together with dementia' significantly reduced the burden experienced by family caregivers of people with dementia, based on a quasi-experimental study involving 15 participants.

The study included pretest and posttest assessments with a follow-up period of 4 months, suggesting that the program could be an effective training tool for caregivers in managing dementia-related challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Living Together with Dementia"-A psychoeducational group programme for family caregivers. Sousa, L., Sequeira, C., Ferré-Grau, C., et al.[2022]

A web-based educational intervention for dementia caregivers was feasible, with 55 out of 60 enrolled participants completing the study and averaging 8 hours of learning over 30 days, indicating strong engagement with the platform.

Participants reported high satisfaction (89%) and implemented skills learned from the program, although the intervention showed only small effect sizes in reducing neuropsychiatric symptoms and caregiver distress, suggesting potential benefits that may need further exploration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caregiver Response to an Online Dementia and Caregiver Wellness Education Platform. Rodriguez, K., Fugard, M., Amini, S., et al.[2022]

Tele-Savvy, an internet-based version of the Savvy Caregiver Program, maintained fidelity to the original program and showed improvements in certain areas, making it a reliable option for dementia caregivers.

Caregivers who participated in Tele-Savvy reported significant reductions in stress, anxiety, and depressive symptoms, as well as improvements in their competence, indicating the program's preliminary efficacy in supporting caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Implementation of Tele-Savvy for Dementia Caregivers: A Department of Veterans Affairs Clinical Demonstration Project. Griffiths, PC., Whitney, MK., Kovaleva, M., et al.[2022]

The Tele-STELLA intervention, involving 124 family Care Partners of individuals with Alzheimer's disease, aims to improve the management of behavioral symptoms through two 8-week videoconferencing components, enhancing both caregiver skills and support networks.

This study will evaluate the effectiveness of Tele-STELLA in reducing behavioral symptoms and caregiver reactivity, addressing a critical need for accessible support for families dealing with advanced dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Tele-STELLA protocol: Telehealth-based support for families living with later-stage Alzheimer's disease. Lindauer, A., Messecar, D., McKenzie, G., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06460012

Study Details | NCT06460012 | Support Via Technology ... STELLA-R is a multicomponent, self-directed, online intervention designed to facilitate effective management of behavioral and psychological symptoms that ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06460012?cond=%22Caregiver%20Burden%22&viewType=Table&rank=8

Study Details | Support Via Technology: Living and Learning ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10518812/

The STELLA-FTD Pilot Study The revised STELLA-FTD intervention was found to be feasible and acceptable, and has potential to improve care partner burden for families living with FTD.

4. ohsu.edu ohsu.edu/oregon-center-for-aging-and-technology/tele-stella-study

The Tele-STELLA Study The Tele-STELLA Study uses video-chat technology to inform and support care partners of persons with Alzheimer's disease.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8449811/

The Tele-STELLA Protocol: Telehealth-based Support for ... Tele-STELLA addresses symptoms that occur in the later stages of dementia, providing families with tools to facilitate effective behavioral management.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04627662

Study Details | NCT04627662 | Using Technology to ... The purpose of this study is to test a revised psychoeducational intervention to help Care Partners for family members with dementia understand and reduce the ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06460012/support-via-technology-living-and-learning-with-advancing-dementia-revised

Living and Learning With Advancing Dementia-REVISED STELLA-R is a multicomponent, self-directed, online intervention designed to facilitate effective management of behavioral and psychological symptoms that are ...