Clinical trial NCT06191198: Communication Bridge 3 Study
Official title: Communication Bridge: Optimizing an Evidence-based Intervention for Individuals With Primary Progressive Aphasia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Primary Progressive Aphasia
Keywords: Aphasia
Dementia
Communication
Frontotemporal Dementia
Alzheimer Disease
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Western University, Canada
name: National Institute on Aging (NIA)
First posted: 2024-01-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: NIH Stage 2 behavioral clinical trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria (person with PPA):

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

Inclusion Criteria (Co-enrolled communication partner):

1. 18+ years of age
2. English as primary language used in daily communication activities (by self-report)
3. Adequate hearing (aided or unaided) for communicating with others in a crowded room (by self-report)
4. Able to pass technology screening\* and demonstrates sufficient knowledge for use of video conference and Communication Bridge™ web application use (with or without training)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Communication Participation Person Centered Goals
timeFrame: 5 assessment time points through study completion (up to 18 months)
measure: Change in Communication Participation
timeFrame: 5 assessment time points through study completion (up to 18 months)
measure: Montgomery Burden Inventory (MBI)
timeFrame: 5 assessment time points through study completion (up to 18 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago - American School Building
state: Illinois
Study officials:
affiliation: Professor of Neurology
name: Emily Roglaski, PhD
role: PRINCIPAL_INVESTIGATOR
References: