CB3 Pilot (Communication Bridge: A Person-centered Internet-based Intervention for Individuals With Primary Progressive Aphasia)

NCT05697380 | Completed Results DMC

• 3 other identifiers: IRB23-13332R56AG055425-06R01AG055425
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate evidence-based treatments for adults with mild Primary Progressive Aphasia (PPA). The aim of the study is to help identify efficacious communication and quality of life interventions for those with PPA and their care-partners. 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 iPad equipped with the necessary applications and features for the study. Participants will complete evaluations, speech therapy sessions with a speech and language therapist, and sessions with a licensed social worker or related clinician. They will have 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

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

Outcome Measures

Primary Outcomes (1)

• Change in Communication Confidence (CCRSA)

  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. (Note Primary Outcome Measure was not collected for care-partners)

  Time Frame: 5 assessment time points through study completion, an average of 1 year, including change over time

Study Arms (1)

Experimental: 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™

Interventions

Communication Bridge™ BEHAVIORAL

Evidence-based speech language therapy treatment will be compared and contrasted.

Experimental: Communication Bridge™

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)

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 may be requested and reviewed to determine eligibility.

Sponsors & Collaborators

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

Study Sites (1)

The Healthy Aging & Alzheimer's Research Care Center (University of Chicago)

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Behavior; Tauopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Dr. Emily Rogalski
• Organization: University of Chicago

emily.rogalski@bsd.uchicago.edu

855-824-7887

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 25, 2023
• Study Start: June 1, 2021
• Primary Completion: July 12, 2023
• Study Completion: July 12, 2023
• Last Updated: October 16, 2024
• Results First Posted: October 16, 2024

Record last verified: 2024-09

Locations

US (1)