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

NCT06613204 | Recruiting DMC

• 2 other identifiers: STUDY00026023R01AG084523
• Study Type: interventional
• Target: 640
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

behavioral intervention; FTD

Outcome Measures

Primary Outcomes (2)

• Revised Memory and Behavior Problems Checklist, Frequency, Original Scale

  Efficacy will be assessed by measuring pre/post changes on the RMBPC. The RMBPC is a 24-item caregiver report measure, 5-point Likert scale with higher scores on frequency indicate more upsetting behaviors Frequency range is 0 (never occurred) to 4 (daily or more often). Frequency score range is 0 to 96

  1 month pre-intervention; 1 week pre-intervention, 4 weeks after intervention start; 8 week post intervention; 2 and 6 months post intervention

• Revised Memory and Behavior Problems Checklist, Reactivity, Original Scale

  Efficacy will be assessed by measuring pre/post changes on the RMBPC. The RMBPC is a 24-item caregiver report measure, 5-point Likert scale with higher scores on reactivity indicate more Care Partner burden. Frequency range is 0 (no burden) to 4 (high burden). Frequency score range is 0 to 96

  1 month pre-intervention; 1 week pre-intervention, 4 weeks after intervention start; 8 week post intervention; 2 and 6 months post intervention

Secondary Outcomes (12)

• Self-efficacy for symptom management and support service use

  1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention

• Neuropsychiatric Inventory-Caregiver Self-efficacy Scale

  1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention

• Preparedness for Caregiving Scale

  1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention

• Personalized Target Behavior Survey

  1 week pre-intervention, 8 week post intervention

• Service and Support use survey

  1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention

Study Arms (3)

Control Group

ACTIVE COMPARATOR

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

Behavioral: STELLA-FTD Control

Test Group

EXPERIMENTAL

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

Behavioral: STELLA-FTD Test

Care Recipients with FTD

NO INTERVENTION

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

Interventions

STELLA-FTD Control BEHAVIORAL

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

Control Group

STELLA-FTD Test BEHAVIORAL

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

Test Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 37655616 BACKGROUND

MeSH Terms

Conditions

Frontotemporal Dementia; Caregiver Burden; Aphasia, Primary Progressive; Corticobasal Degeneration

Condition Hierarchy (Ancestors)

Frontotemporal Lobar Degeneration; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; TDP-43 Proteinopathies; Neurodegenerative Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Neurocognitive Disorders; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior; Aphasia; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Tauopathies

Study Officials

• Allison Lindauer, PhD, APRN

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• Aimee Mooney, MA, CCC-SLP

  Oregon Health and Science University

  STUDY DIRECTOR

Central Study Contacts

Hailey Chatterton, MS

CONTACT

503-568-9725; chatterton@ohsu.edu

Allison Lindauer, PhD, APRN

CONTACT

503-494-6976; lindauer@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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. Interventionists will also be blinded to their group designation (test or control) and the differences between the two programs.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: STELLA-FTD is a 36-week randomized controlled, repeated measures study.

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 25, 2024
• Study Start: June 23, 2025
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: October 27, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 2/15/2025-7/14/2029
• Access Criteria: Scientists can contact our center to request data

Locations

US (1)