Clinical trial NCT06613204: STELLA-FTD: Examination of a Behavior Change Intervention for FTD Family Care Partners
Official title: STELLA-FTD: Examination of a Behavior Change Intervention for FTD Family Care Partners
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Frontotemporal Dementia
Caregiver Burden
Primary Progressive Aphasia(PPA)
Corticobasal Syndrome
Keywords: behavioral intervention
FTD
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2024-09-25
Enrollment: 640
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: STELLA-FTD is a 36-week randomized controlled, repeated measures study.
Primary purpose: SUPPORTIVE_CARE

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 video-conference 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 US.

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 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 weekly brief survey.

Eligibility criteria: Inclusion Criteria: Family Care Partner

* 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

Inclusion Criteria: Person with FTD

* 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: Person with FTD

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

Exclusion Criteria: Family Care Partner

* 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.

Primary outcomes:
measure: Revised Memory and Behavior Problems Checklist, Frequency, Original Scale
timeFrame: 1 month pre-intervention; 1 week pre-intervention, 4 weeks after intervention start; 8 week post intervention; 2 and 6 months post intervention
measure: Revised Memory and Behavior Problems Checklist, Reactivity, Original Scale
timeFrame: 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:
measure: Self-efficacy for symptom management and support service use
timeFrame: 1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention
measure: Neuropsychiatric Inventory-Caregiver Self-efficacy Scale
timeFrame: 1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention
measure: Preparedness for Caregiving Scale
timeFrame: 1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention
measure: Personalized Target Behavior Survey
timeFrame: 1 week pre-intervention, 8 week post intervention
measure: Service and Support use survey
timeFrame: 1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention
measure: Support via Telehealth: Living and Learning with Advancing Frontotemporal Dementia Experience Survey
timeFrame: 1 week post intervention
measure: Orbit Survey
timeFrame: Weekly, starts at Week 1, ends after week 36.
measure: Revised Memory and Behavior Problem Checklist Frontotemporal Degeneration Supplement, Frequency
timeFrame: 1 month pre-intervention; 1 week pre-intervention, 4 weeks after intervention start; 8 week post intervention; 2 and 6 months post intervention
measure: Revised Memory and Behavior Problem Checklist Frontotemporal Degeneration Supplement, Reactivity
timeFrame: 1 month pre-intervention; 1 week pre-intervention, 4 weeks after intervention start; 8 week post intervention; 2 and 6 months post intervention
measure: Clinical Dementia Rating Scale plus Frontotemporal Lobar Degeneration
timeFrame: One time assessment at enrollment
measure: Ten Item Personality Inventory
timeFrame: Once, at Week 1 of intervention
measure: Contact Survey
timeFrame: Week 13, 20, and 36
Other outcomes:
Locations:
Study officials:
affiliation: Oregon Health &amp; Science University
name: Allison Lindauer, PhD, APRN
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health &amp; Science University
name: Aimee Mooney, MA, CCC-SLP
role: STUDY_DIRECTOR
References:
citation: 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.