Communication Bridge: A Person-centered Internet-based Intervention for Individuals With Primary Progressive Aphasia

Study Overview
=================
Brief 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.

Official Title
-----------------
Communication Bridge: A Person-centered Internet-based Intervention for Individuals With Primary Progressive Aphasia

Conditions
-----------------
Primary Progressive Aphasia

Intervention / Treatment
-----------------
* Behavioral: Communication Bridge™
* Behavioral: Evidence-Based Impairment Focused


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: NIH Stage 2 behavioral clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Communication Bridge™<br>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. | Behavioral: Communication Bridge™<br>* Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.<br>|
| Active Comparator: Evidence-Based Impairment Focused<br>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. | Behavioral: Evidence-Based Impairment Focused<br>* Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Communication Confidence PROM | 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. | 5 assessment time points through study completion, an average of 1 year, including change over time | 
| Change in Communication Participation PROM | 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. | 5 assessment time points through study completion, an average of 1 year, including change over time | 
| Change in Communication Participation Person Centered Goals | 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. | 5 assessment time points through study completion, an average of 1 year, including change over time | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aphasia, primary progressive aphasia, dementia, communication, frontotemporal dementia, Alzheimer's disease