- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03371706
Communication Bridge: A Person-centered Internet-based Intervention for Individuals With Primary Progressive Aphasia
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60611
- Mesulam Center for Cognitive Neurology and Alzheimer's Disease - Northwestern University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Communication Bridge™
Participants receive Communication Bridge™, a multi-component, participation-focused, dyadic intervention in which both the person with PPA and their co-enrolled communication partner are intervention recipients.
Communication Bridge™ is modelled on the Living with Aphasia: Framework for Outcome Measurement (A-FROM) and the Care Pathway Model that was developed for persons living with primary progressive aphasia.
Consistent with participation-focused intervention models personally salient training stimuli are incorporated into all therapy activities in the Experimental arm.
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Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.
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Active Comparator: Evidence-Based Impairment Focused
The Control arm includes a non-dyadic intervention in which the person with PPA is the active intervention recipient and their communication partner is in a supporting role.
In the Control arm, participants receive a speech-language intervention designed to address impairment and functional limitations, comprised of activities that address word retrieval and 'automatic' speech production using fixed, non-personalized, stimuli across participants.
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Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Communication Confidence PROM
Time Frame: 5 assessment time points through study completion, an average of 1 year, including change over time
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Communication Confidence Rating Scale in Aphasia, a 0-100 numeric rating scale with 0 representing 'not confident' and 100 representing 'very confident'.
Higher scores indicate greater confidence.
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5 assessment time points through study completion, an average of 1 year, including change over time
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Change in Communication Participation PROM
Time Frame: 5 assessment time points through study completion, an average of 1 year, including change over time
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Communication Participation Item Bank, a 4-point rating scale with 0 representing 'very much' and 3 representing 'not at all'.
Higher scores indicate greater severity of communication challenges.
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5 assessment time points through study completion, an average of 1 year, including change over time
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Change in Communication Participation Person Centered Goals
Time Frame: 5 assessment time points through study completion, an average of 1 year, including change over time
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Goal Attainment Scaling, a 7-point rating scale with -3 representing 'no longer participating' and +3 representing 'exceeded goal'.
Higher scores indicate better progress in goal achievement.
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5 assessment time points through study completion, an average of 1 year, including change over time
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Word accuracy (trained words)
Time Frame: 5 assessment time points through study completion, an average of 1 year, including change over time
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Percent accuracy on trained words
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5 assessment time points through study completion, an average of 1 year, including change over time
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Change in Script accuracy (trained scripts)
Time Frame: 5 assessment time points through study completion, an average of 1 year, including change over time
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Percent accuracy on trained scripts
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5 assessment time points through study completion, an average of 1 year, including change over time
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Emily Rogalski, Ph.D., Northwestern University
Publications and helpful links
General Publications
- Mesulam MM, Coventry C, Kuang A, Bigio EH, Mao Q, Flanagan ME, Gefen T, Sridhar J, Geula C, Zhang H, Weintraub S, Rogalski EJ. Memory Resilience in Alzheimer Disease With Primary Progressive Aphasia. Neurology. 2021 Feb 9;96(6):e916-e925. doi: 10.1212/WNL.0000000000011397. Epub 2021 Jan 13.
- Roberts AC, Rademaker AW, Salley EA, Mooney A, Morhardt D, Fried-Oken M, Weintraub S, Mesulam M, Rogalski E. Communication Bridge-2 (CB2): an NIH Stage 2 randomized control trial of a speech-language intervention for communication impairments in individuals with mild to moderate primary progressive aphasia. Trials. 2022 Jun 13;23(1):487. doi: 10.1186/s13063-022-06162-7.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Neurodegenerative Diseases
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Dementia
- Language Disorders
- Communication Disorders
- Speech Disorders
- Frontotemporal Lobar Degeneration
- Aphasia
- Frontotemporal Dementia
- Aphasia, Primary Progressive
- Pick Disease of the Brain
Other Study ID Numbers
- STU00206086
- 1R01AG055425-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Primary Progressive Aphasia
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Massachusetts General HospitalCompletedLogopenic Variant Primary Progressive Aphasia | Non-Fluent Primary Progressive AphasiaUnited States
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University of Texas at AustinUniversity of California, San Francisco; National Institute on Deafness and...Active, not recruitingPrimary Progressive Aphasia | Aphasia | Semantic Dementia | Logopenic Progressive Aphasia | Semantic Memory Disorder | Nonfluent Aphasia, Progressive | Aphasia, ProgressiveUnited States
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