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

October 23, 2025 updated by: Allison Lindauer, Oregon Health and Science University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

640

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Allison Lindauer, PhD, APRN
  • Phone Number: 503-494-6976
  • Email: lindauer@ohsu.edu

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
Control group, receives information and support in a group setting (N=160 Care Partners).
Behavioral: STELLA-FTD Control
Participants receive information about FTD and support via weekly group video-conference-based meetings.
Experimental: Test Group
Test group, receives information and support in a group setting, but program is different from control (N=160 Care Partners).
Behavioral: STELLA-FTD Test
The test group receives a information and support, but with a focus that is different from the Control Group
No Intervention: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Revised Memory and Behavior Problems Checklist, Frequency, Original Scale
Time Frame: 1 month pre-intervention; 1 week pre-intervention, 4 weeks after intervention start; 8 week post intervention; 2 and 6 months post intervention
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
Time Frame: 1 month pre-intervention; 1 week pre-intervention, 4 weeks after intervention start; 8 week post intervention; 2 and 6 months post intervention
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-efficacy for symptom management and support service use
Time Frame: 1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention
10-item scale to measure self-efficacy. Assesses caregiver certainty that they will use services and support programing. 1= not at all certain, to 10=very certain. Scores range from 10 to 100, with 100 being high certainty.
1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention
Neuropsychiatric Inventory-Caregiver Self-efficacy Scale
Time Frame: 1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention
Measures frequency of behaviors related to frontotemporal dementia and Care Partner confidence in managing behaviors. Frequency is rated on a scale of 1 (occasionally) to 4 (very frequently), severity is rated from 1 (mild) to 3 (severe), and caregiver distress is rated from 0 (no distress) to 5 (extreme or very severe). Total scores are calculated by multiplication of the frequency and severity for each symptom and the addition of all item scores, with a range of 0-144. The distress score total is calculated by the sum of all the individual domain scores, with a range of between 0 and 60. If a behavioral symptom is noted, the care partner is asked to about how confident they are in addressing it, Responses range from 4 (not at all confident), 3 (fairly confident), 2 (confident), and 1 (very confident).
1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention
Preparedness for Caregiving Scale
Time Frame: 1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention
10-item measure that assesses how prepared care partners feel to care for their family member with dementia. Ranges from 0 (not at all prepared) to 40 (very well prepared).
1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention
Personalized Target Behavior Survey
Time Frame: 1 week pre-intervention, 8 week post intervention
On STELLA-FTD Website, measures frequency and reactivity of up to 3 personalized behaviors identified by Care Partners. Care partners rate how often the 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 4 for each Target behavior. Higher scores indicate higher frequency and burden.
1 week pre-intervention, 8 week post intervention
Service and Support use survey
Time Frame: 1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention
10-item survey that queries participants about service use. Score is not on a scale.
1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention
Support via Telehealth: Living and Learning with Advancing Frontotemporal Dementia Experience Survey
Time Frame: 1 week post intervention
18-item- survey on satisfaction, privacy, ease of use. Scores range from 1 (strongly disagree) to 5 (strongly agree). Total score ranged 18-90, higher scores are better
1 week post intervention
Orbit Survey
Time Frame: Weekly, starts at Week 1, ends after week 36.
Weekly survey of burden, service use, medication use. Score is not on a scale.
Weekly, starts at Week 1, ends after week 36.
Revised Memory and Behavior Problem Checklist Frontotemporal Degeneration Supplement, Frequency
Time Frame: 1 month pre-intervention; 1 week pre-intervention, 4 weeks after intervention start; 8 week post intervention; 2 and 6 months post intervention
Measures frequency of upsetting frontotemporal behaviors. 9 items, scores range from 0 (no behaviors) to 36 (all behaviors)
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 Problem Checklist Frontotemporal Degeneration Supplement, Reactivity
Time Frame: 1 month pre-intervention; 1 week pre-intervention, 4 weeks after intervention start; 8 week post intervention; 2 and 6 months post intervention
Measures caregivers reactions to upsetting frontotemporal behaviors. 9 items, scores range from 0 (no reactivity) to 36 (high reactivity)
1 month pre-intervention; 1 week pre-intervention, 4 weeks after intervention start; 8 week post intervention; 2 and 6 months post intervention
Clinical Dementia Rating Scale plus Frontotemporal Lobar Degeneration
Time Frame: One time assessment at enrollment
This is an 8-item survey that assesses disease severity, with 0=no impairment to 3=severe impairment. Range is 0-24 (Sum of boxes)
One time assessment at enrollment
Ten Item Personality Inventory
Time Frame: Once, at Week 1 of intervention

10 items that assess personality type. Respondents note how they agree with each. personality type, from

1=Disagree strongly 2 = Disagree moderately 3 = Disagree a little 4 = Neither agree nor disagree 5 = Agree a little 6 = Agree moderately 7 = Agree strongly

Score is not on a scale.
Once, at Week 1 of intervention
Contact Survey
Time Frame: Week 13, 20, and 36
Nine questions query caregivers about if they contacted other caregivers in the study, and, if so, how often. Score is not on a scale
Week 13, 20, and 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Allison Lindauer, PhD, APRN, Oregon Health and Science University
  • Study Director: Aimee Mooney, MA, CCC-SLP, Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2025

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

September 17, 2024

First Submitted That Met QC Criteria

September 23, 2024

First Posted (Actual)

September 25, 2024

Study Record Updates

Last Update Posted (Estimated)

October 27, 2025

Last Update Submitted That Met QC Criteria

October 23, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00026023
  • R01AG084523 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Aggregated data for journal articles and presentations, IPD via data request to OHSU

IPD Sharing Time Frame

2/15/2025-7/14/2029

IPD Sharing Access Criteria

Scientists can contact our center to request data

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Study Data/Documents

  1. data set

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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