STELLA-FTD: Examination of a Behavior Change Intervention for FTD Family Care Partners

NCT ID: NCT06613204

Last Updated: 2025-10-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 640 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-23
• Study Completion Date: 2029-06-30

Brief Summary

The purpose of this nationwide study is to test STELLA-FTD (Support via Telehealth: Living and Learning with Advancing Alzheimer's Disease)-FTD, an intervention to specifically address the needs of family Care Partners of persons with frontotemporal degeneration (FTD). STELLA-FTD is a multicomponent videoconference-based intervention designed to facilitate effective use of community and peer resources to foster effective management of behavioral and psychological symptoms of dementia. The study is recruiting families from across the United States.

Detailed Description

The study will enroll a total sample of up to 640 participants: 320 family Care Partners and their 320 Care Recipients with FTD. For our study "family Care Partner" includes any person who is considered "family" to the person with FTD, such as direct relations, fictive kin, close friends and neighbors. "Care Recipient" is defined as an individual with an FTD diagnosis noted by the AFTD: bv-FTD, PPA, progressive supranuclear palsy (PSP), corticobasal degeneration (CBD), or ALS with FTD. Care Recipients with FTD will not participate in intervention but will be consented (and thus enrolled) because data will be collected about them. The study will test to see if our program helps Care Partners.

The STELLA-FTD intervention is delivered over 8 sessions within 10 consecutive weeks in 1-hour "live" video-based group sessions led by two guides. There will be two intervention groups, the control group and the test group. There will be up to 8 Care Partners per group, which allows for the development of mutual trust and commitment.

Care Partners will be randomized to either the test or control group using an electronic randomization process and will be blinded to their group designation. Both groups will receive information and support (via videoconferencing). The test group will receive a different program than the control group. Care Partners will fill out 6 long surveys while in the study, and a brief weekly survey.

Conditions

Frontotemporal Dementia; Caregiver Burden; Primary Progressive Aphasia (PPA); Corticobasal Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Control Group

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

Group Type: ACTIVE_COMPARATOR

STELLA-FTD Control

Intervention Type: BEHAVIORAL

Participants receive information about FTD and support via weekly group video-conference-based meetings.

Test Group

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

Group Type: EXPERIMENTAL

STELLA-FTD Test

Intervention Type: BEHAVIORAL

The test group receives a information and support, but with a focus that is different from the Control Group

Care Recipients with FTD

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

STELLA-FTD Control

Participants receive information about FTD and support via weekly group video-conference-based meetings.

Intervention Type: BEHAVIORAL

STELLA-FTD Test

The test group receives a information and support, but with a focus that is different from the Control Group

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Adult caring for family member with FTD.
• Provides 4 or more hours of care/week. Does not have to reside with.
• Identifies at least 2 moderately upsetting behaviors in the person with FTD.
• Speaks and understands English to be able to participate in intervention.
• Owns a telephone (smartphone, cell phone or landline).
• Has email and mailing address to receive computer, study materials and surveys.
• Provides informed consent to participate in the research.
• Lives in the US

• Diagnosis of FTD
• Family member of a Care Partner (this can be a relative, spouse, or close kin that is considered family).
• Lives in US

Exclusion Criteria

• No Frontotemporal Degeneration diagnosis.
• Unable to leave Care Partner during STELLA-FTD sessions.
• Enrolled in hospice.

• Unable to find activity for Care Recipient during STELLA-FTD sessions to allow Care Partner to work privately with Guide and other Care Partners.
• Hearing and/or vision problems severe enough to prevent participation.
• Refuses to be video-recorded during STELLA-FTD sessions.
• Unwilling or unable to adequately follow study instructions and participate in study procedures.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Allison Lindauer

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Allison Lindauer, PhD, APRN

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Aimee Mooney, MA, CCC-SLP

Role: STUDY_DIRECTOR

Oregon Health and Science University

Locations

Oregon Health & Science University

Portland, Oregon, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Hailey Chatterton, MS

Role: CONTACT

chatterton@ohsu.edu

503-568-9725

Allison Lindauer, PhD, APRN

Role: CONTACT

lindauer@ohsu.edu

503-494-6976

Facility Contacts

Hailey Chatterton, MS

Role: primary

chatterton@ohsu.edu

503-568-9725

References

Lindauer A, Smith S, Gothard S, Mattek N, Tran L, Mooney A. 'There's no straight line...' a consumer-informed intervention for FTD family care partners: the STELLA-FTD pilot study. Aging Ment Health. 2023 Sep-Oct;27(10):2000-2010. doi: 10.1080/13607863.2023.2250741. Epub 2023 Sep 1.

Reference Type: BACKGROUND

PMID: 37655616 (View on PubMed)

Study Documents

Document Type: data set

View Document

Other Identifiers

R01AG084523

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00026023

Identifier Type: -

Identifier Source: org_study_id