Trials / Recruiting
RecruitingNCT06613204
STELLA-FTD: Examination of a Behavior Change Intervention for FTD Family Care Partners
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 640 (estimated)
- Sponsor
- Oregon Health and Science University · Academic / Other
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | STELLA-FTD Control | Participants receive information about FTD and support via weekly group video-conference-based meetings. |
| BEHAVIORAL | STELLA-FTD Test | The test group receives a information and support, but with a focus that is different from the Control Group |
Timeline
- Start date
- 2025-06-23
- Primary completion
- 2029-06-01
- Completion
- 2029-06-01
- First posted
- 2024-09-25
- Last updated
- 2025-10-27
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT06613204. Inclusion in this directory is not an endorsement.