Tele-STELLA for Alzheimer's Caregivers

(Tele-STELLA Trial)

Overseen By Hannah Bernard

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Disqualifiers: Dementia not ADRD, Early stage dementia, Hearing/vision problems, others

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

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a video-based program called Tele-STELLA, designed to help family members caring for someone with dementia manage difficult behaviors and reduce stress. The program connects caregivers with professionals to find ways to handle upsetting situations that often occur in the later stages of dementia. Caregivers who spend at least 4 hours a week assisting a family member with moderate to late-stage Alzheimer's or related dementias might be a good fit. The goal is to ease the burden on caregivers and improve their ability to support their loved ones.

As an unphased trial, this study offers caregivers a unique opportunity to access innovative support strategies and contribute to valuable research.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on providing support and education for caregivers rather than altering medical treatments.

What prior data suggests that the Tele-STELLA intervention is safe for Care Partners?

Research shows that Tele-STELLA, a video call-based program, helps families dealing with late-stage dementia by assisting caregivers in managing difficult behaviors often seen in dementia. Previous studies indicate that this program uses technology to provide caregivers with guidance and tools, enabling them to handle challenging behaviors more effectively.

The studies do not mention any negative side effects or safety issues, suggesting that the program is well-tolerated. As a support program rather than a medication, Tele-STELLA is generally safe for participants. Participants use technology to learn strategies, which further reduces any physical risk.

Overall, this program appears to be a safe and helpful option for those caring for loved ones with dementia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Tele-STELLA for Alzheimer's caregivers because it offers a unique, digital approach to support. Unlike traditional methods that often involve in-person therapy or support groups, Tele-STELLA provides remote, accessible support through telehealth. This allows caregivers to receive guidance and resources from the comfort of their own home, making it easier to balance their responsibilities. Additionally, Tele-STELLA aims to reduce caregiver stress and improve their ability to care for loved ones with dementia, potentially leading to better outcomes for both caregivers and care recipients.

What evidence suggests that the Tele-STELLA intervention is effective for managing distressing behaviors in dementia?

Research shows that Tele-STELLA, which participants in this trial will receive, is designed to help families manage difficult behaviors in the later stages of dementia. Studies suggest it provides tools that effectively reduce these behaviors, easing the burden on caregivers. Early results from similar programs, such as STELLA-FTD, indicated it might lower the stress caregivers face when managing challenging behaviors. This approach is both practical and promising for improving the lives of those caring for loved ones with dementia. ^{3 4 6 7 8}

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 family members caring for individuals with moderate to late-stage Alzheimer's or related dementias, who are dealing with at least two distressing behaviors from the person they're caring for that happen three or more times a week.

Inclusion Criteria

My family member has been diagnosed with moderate to late-stage Alzheimer's or related dementia.

Exhibits 2 or more behaviors listed on RMBPC that are bothersome to the Care Partner and occur 3 or more times/week at study enrollment

Care Recipient

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Tele-STELLA intervention where Care Partners and Guides meet via videoconference to manage behavioral and psychological symptoms of dementia

8 sessions

8 virtual sessions

Follow-up

Participants are monitored for changes in behavioral symptoms and Care Partner burden

12 months

Post-intervention Support

Care Partners are linked to each other to sustain support after the main intervention

What Are the Treatments Tested in This Trial?

Interventions

• Tele-STELLA

Trial Overview

Tele-STELLA, a videoconference-based program, is being tested. It aims to educate and support caregivers by helping them manage difficult behaviors associated with advanced dementia through sessions with professional Guides.

How Is the Trial Designed?

Group I: Care Partners Experimental Treatment 1 Intervention

Based on previous work, we will recruit up to 75 Care Partners and their 75 care recipients with dementia. This allows for 20% attrition. We will recruit participants from Alzheimer's Disease Research Centers (ADRCs) and other national locations.

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Published Research Related to This Trial

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]

Televideo monitoring significantly improved medication compliance in individuals with mild dementia, achieving an 81% compliance rate compared to 66% in the control group, based on over 4000 interactions with 8 participants.

The study demonstrated that while video-monitored participants maintained stable compliance, those without monitoring experienced a decline in compliance, highlighting the potential of this technology to support medication management in vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth home monitoring of solitary persons with mild dementia. Smith, GE., Lunde, AM., Hathaway, JC., et al.[2017]

The TeleFAMILIES telehealth intervention significantly reduced caregiver burden and depressive symptoms among 216 caregivers of persons with dementia, with notable improvements in scores on the Zarit Burden Interview and Center for Epidemiologic Studies Depression Scale.

Caregivers using the TeleFAMILIES program experienced greater improvements in managing behavioral symptoms of dementia compared to those receiving in-person support, highlighting the effectiveness and convenience of telehealth services in caregiver support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the efficacy of TeleFAMILIES: a telehealth intervention for caregivers of community-dwelling people with dementia. Rice, JD., Sperling, SA., Brown, DS., et al.[2022]

Citations

1.

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.

2.

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.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04627662

Study Details | NCT04627662 | Using Technology to ...

Establish the efficacy of Tele-STELLA in reducing the frequency of behavioral and psychological symptoms of dementia (BPSD) and Care Partner reactivity to the ...

4.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/abs/10.1111/jan.14980

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 behavioural management.

5.

tandfonline.com

tandfonline.com/doi/abs/10.1080/13607863.2023.2250741

the STELLA-FTD pilot study

The post-intervention findings suggest STELLA-FTD has the potential to reduce care partner reactivity to upsetting behaviors and to decrease care partner burden ...

6.

theaftd.org

theaftd.org/posts/1ftd-in-the-news/blog-stella-ftd-study-2/

AFTD Grant Recipient Evaluates Efficacy of Remote ...

A pilot study published in the medical journal Aging & Mental Health evaluates the efficacy of the remote caregiver support program STELLA-FTD.

7.

researchgate.net

researchgate.net/publication/353375708_The_Tele-STELLA_protocol_Telehealth-based_support_for_families_living_with_later-stage_Alzheimer's_disease

The Tele‐STELLA protocol: Telehealth‐based support for ...

Impact Tele‐STELLA addresses symptoms that occur in the later stages of dementia, providing families with tools to facilitate effective ...

8.

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.