STELLA-FTD for Frontotemporal Dementia

(STELLA-FTD Trial)

Overseen By Hailey Chatterton, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Disqualifiers: Hearing, vision problems, hospice, others

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

Compensation: Varies

Number of Visits: 8

640 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests STELLA-FTD, a telehealth program designed to support family caregivers of individuals with frontotemporal dementia (FTD). The program assists caregivers in managing the challenging behaviors and psychological symptoms associated with FTD by utilizing community and peer resources. The trial includes a test group receiving a specific intervention and a control group receiving general support. Family caregivers in the U.S. who provide at least four hours of care per week to a person with FTD and can identify challenging behaviors are well-suited for this study. As an unphased trial, this study offers caregivers the chance to contribute to innovative research that could enhance support systems for FTD care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on supporting family caregivers, so it's unlikely to require changes to your medication.

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

Research has shown that the STELLA-FTD program is practical and well-received by families dealing with frontotemporal dementia (FTD). In a previous study, participants found the program helpful for managing FTD challenges. The program is entirely online and focuses on educating and supporting family caregivers.

As an educational program rather than a drug treatment, it has not reported any negative effects. The study aims to enhance the experience of those caring for loved ones with FTD by teaching them how to handle behavioral and psychological symptoms. This indicates that the program is safe and well-tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the STELLA-FTD program for frontotemporal dementia (FTD) because it offers a unique approach by focusing on improving the support systems for caregivers. Unlike most treatments that directly target the symptoms of FTD in patients, STELLA-FTD aims to enhance the quality of care through structured group support and information-sharing for care partners. This approach hopes to indirectly improve patient outcomes by empowering those who care for them, potentially leading to less stress and better management of the condition. This innovative focus on the caregiving environment represents a fresh perspective in the management of FTD, which traditionally relies more on pharmacological interventions.

What evidence suggests that STELLA-FTD is effective for frontotemporal dementia?

Research has shown that the STELLA-FTD program, available to participants in this trial, could assist families managing frontotemporal dementia (FTD). Studies suggest this program might reduce stress and burden on family members caring for someone with FTD. It offers education and support through online sessions, which help manage difficult behaviors associated with FTD. Evidence also indicates that it could help caregivers respond more calmly to these challenging behaviors. Overall, early findings are promising for helping families cope more effectively. ^{1 3 6 7 8}

Who Is on the Research Team?

Allison Lindauer, PhD, APRN

Principal Investigator

Oregon Health and Science University

Aimee Mooney, MA, CCC-SLP

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for family caregivers in the US who provide at least 4 hours of care per week to a relative with frontotemporal degeneration (FTD). They must identify at least two distressing behaviors in their relative, speak English, have an email and mailing address, and own a phone. The person with FTD they're caring for must also consent to participate.

Inclusion Criteria

I provide at least 4 hours of care per week.

I speak and understand English well enough to participate.

I am a family member who helps care for someone with a health condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

STELLA-FTD intervention delivered over 8 sessions within 10 consecutive weeks in 1-hour video-based group sessions

10 weeks

8 sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after intervention

26 weeks

What Are the Treatments Tested in This Trial?

Interventions

• STELLA-FTD

Trial Overview STELLA-FTD is being tested; it's a video-conference based program designed to help caregivers manage behavioral symptoms of dementia by using community and peer resources effectively. Participants will be compared against a control group not receiving this specific intervention.

How Is the Trial Designed?

Group I: Test Group Experimental Treatment 1 Intervention

Test group, receives information and support in a group setting, but program is different from control (N=160 Care Partners).

Group II: Control Group Active Control 1 Intervention

Control group, receives information and support in a group setting (N=160 Care Partners).

Group III: Care Recipients with FTD Active Control 1 Intervention

Care recipients are consented to inform them of their rights, but they do not take part in any activities (N=320 Care Recipients).

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. 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.

2. 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 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05338710

Study Details | NCT05338710 | Support Via Technology ... Assess the preliminary efficacy of STELLA-FTD on the primary outcomes: reducing the frequency of behavioral symptoms and care partner reactivity to the ...

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

The STELLA-FTD Study STELLA-FTD is a completely online study that helps educate and support family Care Partners by teaching ways to help manage the challenges caused by FTD.

5. trialx.com trialx.com/clinical-trials/listings/323508/stella-ftd-examination-of-a-behavior-change-intervention-for-ftd-family-care-partners/

STELLA-FTD: Examination of a Behavior Change ... The purpose of this nationwide study is to test STELLA-FTD (Support via Telehealth: Living and Learning with Advancing Alzheimer's Disease)-FTD, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06613204?cond=Corticobasal%20syndrome%20OR%20%22%22&aggFilters=status:not%20rec&viewType=Table&rank=8

STELLA-FTD: Examination of a Behavior Change ... The purpose of this nationwide study is to test STELLA-FTD (Support via Telehealth: Living and Learning with Advancing Alzheimer's Disease)-FTD, ...

7. ftdregistry.org ftdregistry.org/find-a-study/

Find A Study - FTD Disorders Registry The upliFT-D Study, sponsored by Passage Bio Inc., is an interventional study investigating the safety and tolerability of a gene therapy (PBFT02) for persons ...

8. neurology.org neurology.org/doi/10.1212/WNL.0000000000208688

Exploring Quality of Life Impact Reported by Caregivers in ... As the most common form of dementia affecting persons under age 60, FTD can cause financial, career, and household challenges for caregivers ...