Communication Bridge 3 Study

NCT ID: NCT06191198

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-23
• Study Completion Date: 2028-07-15

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.

Detailed 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.

Conditions

Primary Progressive Aphasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Communication Bridge™

Intervention Type: BEHAVIORAL

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.

Group Type: ACTIVE_COMPARATOR

Evidence-Based Impairment Focused

Intervention Type: BEHAVIORAL

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

Interventions

Communication Bridge™

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

Intervention Type: BEHAVIORAL

Evidence-Based Impairment Focused

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western University, Canada

OTHER

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emily Roglaski, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor of Neurology

Locations

University of Chicago - American School Building

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Matthew Bona, MPH

Role: CONTACT

cbtrial@uchicago.edu

773-702-1220 ext. 51145

Emily Cummings

Role: CONTACT

cbtrial@uchicago.edu

773-702-1221

Facility Contacts

Matthew Bona, MPH

Role: primary

cbtrial@uchicago.edu

Other Identifiers

7R01AG055425-07

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB23-1175

Identifier Type: -

Identifier Source: org_study_id