Communication Bridge 3 Study

NCT06191198 | Recruiting Phase 2 DMC

• 2 other identifiers: IRB23-11757R01AG055425-07
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Progressive Aphasia

Keywords

Aphasia; Dementia; Communication; Frontotemporal Dementia; Alzheimer Disease

Outcome Measures

Primary Outcomes (3)

• 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 (up to 18 months)

• 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.

  5 assessment time points through study completion (up to 18 months)

• 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).

  5 assessment time points through study completion (up to 18 months)

Study Arms (2)

Communication Bridge™

EXPERIMENTAL

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 Impairment Focused

ACTIVE COMPARATOR

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

Interventions

Communication Bridge™ BEHAVIORAL

Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.

Communication Bridge™

Evidence-Based Impairment Focused BEHAVIORAL

Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.

Evidence-Based Impairment Focused

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• + 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead
• Western University, Canada: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Chicago - American School Building

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Aphasia, Primary Progressive; Aphasia; Dementia; Communication; Frontotemporal Dementia; Alzheimer Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Behavior; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Neurodegenerative Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Tauopathies

Study Officials

• Emily Roglaski, PhD

  Professor of Neurology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Bona, MPH

CONTACT

773-702-1220; cbtrial@uchicago.edu

Emily Cummings

CONTACT

773-702-1221; cbtrial@uchicago.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: NIH Stage 2 behavioral clinical trial

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 5, 2024
• Study Start: August 23, 2024
• Primary Completion (Estimated): July 15, 2028
• Study Completion (Estimated): July 15, 2028
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)