Communication Bridge 3 Study

Официальное название

Communication Bridge: Optimizing an Evidence-based Intervention for Individuals With Primary Progressive Aphasia

Обзор

This study will use a randomized controlled trial design to evaluate the effect of two evidence-based treatments for adults with mild-moderate Primary Progressive Aphasia (PPA). The aim of the study is to help us better understand the effects of speech-language therapy on communication abilities in individuals with PPA.

Подробное описание

Participants with a diagnosis of PPA and their actively-engaged care partners will be involved in the study for approximately 17 months. Each participant will receive a laptop equipped with the necessary applications and features for the study. Participants will receive up to 10 evaluations and 20 speech therapy sessions with a licensed speech therapist, as well as access to Communication Bridge, a personalized web application to practice home exercises that reinforce treatment strategies. There are no costs to participate in this study.

Вмешательства

• Поведенческое Communication Bridge™
  Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.
• Поведенческое Evidence-Based Impairment Focused
  Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.

Первичные конечные точки

• Change in Communication Participation Person Centered Goals [Срок оценки: 5 assessment time points through study completion (up to 18 months)]
• Change in Communication Participation [Срок оценки: 5 assessment time points through study completion (up to 18 months)]
• Montgomery Burden Inventory (MBI) [Срок оценки: 5 assessment time points through study completion (up to 18 months)]

Критерии участия

Inclusion Criteria (person with PPA):

• Meets diagnostic criteria for PPA based on neurologist and supporting medical assessments (extracted from medical records)
• English as primary language used in daily communication activities (by self-report)
• Adequate hearing (aided or unaided) for communicating with others in a crowded room (by self-report)
• Adequate vision (aided or unaided) for reading a newspaper, or other functional materials (by self-report)
• Able to pass technology screening and demonstrates sufficient knowledge for use of video conference and Communication Bridge™ web application use (with or without training)
• Geriatric Depression Scale score ≤ 9
• Mild-moderate PPA informed by a structured interview with a speech-language pathologist and a standardized testing battery.

Inclusion Criteria (Co-enrolled communication partner):

• 18+ years of age
• English as primary language used in daily communication activities (by self-report)
• Adequate hearing (aided or unaided) for communicating with others in a crowded room (by self-report)
• Able to pass technology screening\* and demonstrates sufficient knowledge for use of video conference and Communication Bridge™ web application use (with or without training)

Критерии исключения

• A dementia diagnosis other than Primary Progressive Aphasia
• Participation is co-enrolled in an outside speech language therapy program during the study course.
• Communication partners will be excluded if they have a pre-existing communication impairment that would affect study participation (e.g., aphasia, dementia)

Medical records will be requested and reviewed to determine eligibility

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Chicago - American School Building — Chicago

Идентификаторы

NCT: NCT06191198 · IRB23-1175 · 7R01AG055425-07

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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