N/A
N=190
Communication Bridge 2
Primary Progressive Aphasia
Bottom Line
View on ClinicalTrials.gov: NCT03371706 ↗Enrolled (actual)
190
Serious AEs
11.6%
Results posted
Oct 2024
Primary outcome: Primary: Change in Communication Confidence (CCRSA) — 72.6; 72.9; 73.7; 74.5 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Communication Bridge™ (Behavioral); Evidence-Based Impairment Focused (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Chicago
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Communication Confidence (CCRSA) |
72.6; 72.9; 73.7; 74.5; 72.1; 73.1 | — |
| PRIMARY Change in Communication Participation Item Bank (CPIB) |
46.0; 47.1; 47.4; 47.7; 45.6; 46.8 | — |
| PRIMARY Change in Communication Participation Person Centered Goals |
3.8; 6.9; 29.6; 44.0; 66.7; 49.1 | — |
Summary
This study will use a randomized controlled trial design to evaluate the effect of two evidence-based treatments for adults with mild 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.
Participants with a diagnosis of PPA and their actively-engaged care partners will be involved in the study for 12 months. Each participant will receive a laptop equipped with the necessary applications and features for the study. Participants will receive 5 evaluations and 15 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):
- 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.
Data sourced from ClinicalTrials.gov (NCT03371706). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.