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

Trial Summary

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 data supports the effectiveness of the treatment STELLA-R Curriculum, STELLA-R, Support Via Technology: Living and Learning With Advancing Dementia-REVISED, Tele-STELLA?

Research on similar online programs like Tele-Savvy shows that caregivers find these interventions acceptable and helpful in understanding dementia and improving caregiving skills. Additionally, the Tele-STELLA protocol aims to reduce behavioral symptoms of dementia and improve caregiver responses, suggesting potential benefits for caregivers. ^{1 2 3 4 5}

Is the Online Support Program for Dementia Caregivers safe for participants?

The available research on similar online support programs for dementia caregivers, like Tele-STELLA and Tele-Savvy, focuses on their acceptability and effectiveness, but does not report any safety concerns for participants. ^{1 2 3 6 7}

What makes the STELLA-R treatment unique for dementia caregivers?

The STELLA-R treatment is unique because it is an online support program specifically designed for dementia caregivers, combining live tele-conferences and video modules to provide education and support directly in caregivers' homes, overcoming the logistical challenges of in-person programs. ^{2 4 8 9 10}

What is the purpose of this trial?

STELLA-R is a multicomponent, self-directed, online intervention designed to facilitate effective management of behavioral and psychological symptoms that are common in many types of dementia. The curriculum instructs care partners to use the ABC approach, a cognitive behavioral technique that teaches care partners to describe a Behavior, then consider the Activators and Consequences of a care recipient behavior. The goal of this intervention is to reduce care partner burden and decrease reactivity to upsetting behaviors.

Research Team

Allison Lindauer, PhD

Principal Investigator

Oregon Health and Science University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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]

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]

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 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]

References

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

The Tele-STELLA protocol: Telehealth-based support for families living with later-stage Alzheimer's disease. [2022]

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

An Online Program for Caregivers of Persons Living With Dementia: Lessons Learned. [2022]

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

Caregivers' experience with Tele-Savvy Caregiver Program post-hospitalization. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Caregiver Response to an Online Dementia and Caregiver Wellness Education Platform. [2022]

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

"Living Together with Dementia"-A psychoeducational group programme for family caregivers. [2022]

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

Enhancing Dementia Knowledge and Self-Efficacy of In-Home Supportive Services Caregivers Through Online Training. [2023]

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

SafeHome: A Serious Game to Promote Safe Environments for Persons Living with Dementia. [2020]

8. England pubmed.ncbi.nlm.nih.gov

A systematic review of Internet-based supportive interventions for caregivers of patients with dementia. [2022]

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

Development and Implementation of Tele-Savvy for Dementia Caregivers: A Department of Veterans Affairs Clinical Demonstration Project. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

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