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NCT Number: NCT06613204

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

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.

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Key information

Conditions

Frontotemporal Dementia Aphasia Aphasia, Primary Progressive Behavior Behavioral Symptoms Brain Diseases Caregiver Burden Central Nervous System Diseases Communication Disorders Corticobasal Degeneration Corticobasal Syndrome Dementia Frontotemporal Lobar Degeneration Language Disorders Mental Disorders Metabolic Diseases Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Primary Progressive Aphasia (PPA) Proteostasis Deficiencies Signs and Symptoms Speech Disorders Stress, Psychological TDP-43 Proteinopathies Tauopathies

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location status: Recruiting

Location contact

Hailey Chatterton, MS

CONTACT

[email protected]

503-568-9725

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

STELLA-FTD Control

Behavioral

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

STELLA-FTD Test

Behavioral

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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.

  2. 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).

  3. 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).

  4. 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.

  5. 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.

  6. 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

  7. 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.

  8. 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)

  9. 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)

  10. 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)

  11. 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.

  12. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Allison Lindauer, PhD, APRN

CONTACT

[email protected]

503-494-6976

Hailey Chatterton, MS

CONTACT

[email protected]

503-568-9725

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: STELLA-FTD

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Sep 25, 2024
Registry last updated
Oct 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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