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Идёт набор NCT06613204

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

Без фазы С лечением Frontotemporal Dementia Caregiver Burden Primary Progressive Aphasia (PPA) Corticobasal Syndrome

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: STELLA-FTD Control, STELLA-FTD Test.
Кому может быть актуально
Состояния в реестре: Frontotemporal Dementia, Caregiver Burden, Primary Progressive Aphasia (PPA), Corticobasal Syndrome. Базовые параметры: 18 лет — 100 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое STELLA-FTD Control
    Participants receive information about FTD and support via weekly group video-conference-based meetings.
  • Поведенческое STELLA-FTD Test
    The test group receives a information and support, but with a focus that is different from the Control Group

Первичные конечные точки

  • Revised Memory and Behavior Problems Checklist, Frequency, Original Scale [Срок оценки: 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 [Срок оценки: 1 month pre-intervention; 1 week pre-intervention, 4 weeks after intervention start; 8 week post intervention; 2 and 6 months post intervention]
Вторичные конечные точки (12)
  • Self-efficacy for symptom management and support service use [Срок оценки: 1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention]
  • Neuropsychiatric Inventory-Caregiver Self-efficacy Scale [Срок оценки: 1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention]
  • Preparedness for Caregiving Scale [Срок оценки: 1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention]
  • Personalized Target Behavior Survey [Срок оценки: 1 week pre-intervention, 8 week post intervention]
  • Service and Support use survey [Срок оценки: 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 [Срок оценки: 1 week post intervention]
  • Orbit Survey [Срок оценки: Weekly, starts at Week 1, ends after week 36.]
  • Revised Memory and Behavior Problem Checklist Frontotemporal Degeneration Supplement, Frequency [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: One time assessment at enrollment]
  • Ten Item Personality Inventory [Срок оценки: Once, at Week 1 of intervention]
  • Contact Survey [Срок оценки: Week 13, 20, and 36]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • Oregon Health & Science University — Portland

Публикации

  • 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

Идентификаторы

NCT: NCT06613204 · STUDY00026023 · R01AG084523

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗