Communication Bridge 3 Study

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

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

Eligibility criteria

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)

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Chicago - American School Building — Chicago

Identifiers

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

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗