Communication Bridge 3 Study

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified April 2025 by University of Chicago
Sponsor
University of Chicago
Information Provided by (Responsible Party)
University of Chicago
Clinicaltrials.gov Identifier
NCT06191198
Other Study ID Numbers:
IRB23-1175
First Submitted
December 19, 2023
First Posted
January 4, 2024
Last Update Posted
May 29, 2025
Last Verified
April 2025

ClinicalTrials.gov processed this data on May 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study 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.

Condition or DiseaseIntervention/Treatment
Primary Progressive Aphasia
Behavioral: Communication Bridge™Behavioral: Evidence-Based Impairment Focused

Study Design

Study TypeInterventional
Actual Enrollment200 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingTriple
Primary PurposeTreatment
Official TitleCommunication Bridge: Optimizing an Evidence-based Intervention for Individuals With Primary Progressive Aphasia
Study Start DateAugust 22, 2024
Actual Primary Completion Date2yrs 1mo from now
Actual Study Completion Date2yrs 1mo from now

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures
  1. 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.
  2. Change in Communication Participation
    The CPIB measure is a 10-item, disorder-generic, Likert scale that asks persons to rate how their condition interferes with participating in daily communication activities (e.g., talking to people you know/do not know, securing a turn in a fast-moving conversation). The psychometric properties of the measure have been published previously (Baylor et al., 2013; Baylor et al., 2019). Both raw and T-scores are available. The CPIB T-score has a theoretical mean of 50 and standard deviation of 10 with higher numbers reflecting higher levels of participation in communication activities.
  3. Montgomery Burden Inventory (MBI)
    The MBI is a pen/paper Likert scale with 16 items distributed across three subscales (Montgomery et al., 1985) completed by the care partner. Total and mean item scores are calculated for each of the three subscales: Objective burden is defined as the perceived infringement of disruption of tangible aspects of a caregiver's life; Subjective demand/relational burden is typically described as the extent to which the caregiver perceives that the care recipient is overly demanding in the context of caregiving; Subjective stress burden is the emotional impact of caregiving responsibilities. Participants rate each item with a score between 1 (Not at all) and 5 (A great deal) corresponding to the amount of perceived burden. Higher scores reflect increased burden. Internal consistency .81 to .90. Construct validity demonstrated in mixed cohort of care partners of persons with dementia. Test-retest stability coefficients are robust (ICC of 0.92 to 0.91) (Farley et al., 2010).

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion 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

Contacts and Locations

Sponsors and CollaboratorsUniversity of Chicago
Locations
University of Chicago - American School Building | Chicago Illinois, United States, 60637
Investigators
Principal Investigator: Emily Roglaski, PhD, Professor of Neurology