Communication Bridge Pilot Study

Primary Progressive Aphasia Clinical Trial

— CB3_1  

Official title:

Communication Bridge: Optimizing an Evidence-based Intervention for Individuals With Primary Progressive Aphasia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06211374
• Other study ID #: IRB23-1620
• Secondary ID: 7R01AG055425-07
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: May 2024
• Source: University of Chicago
• Contact: Matthew Bona, MPH
• Phone: 773-702-1220
• Email: cbtrial[@]uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the effectiveness and feasibility of evidence-based interventions in individuals living with mild to moderate primary progressive aphasia (PPA) that address communication-focused outcomes.

Description:

The purpose of this study is to evaluate the effectiveness and feasibility of evidence-based interventions in individuals living with mild to moderate primary progressive aphasia (PPA) that address communication-focused outcomes. The study team aims to enhance the personal relevance and therapeutic impact of goal attainment scaling (GAS) while building self-efficacy within a self-management framework. This study will be a continuation of one of the largest non-pharmacologic intervention studies for individuals with PPA to date. It will add critical information regarding the effectiveness of telepractice interventions for communication disorders in adults with primary progressive aphasia specifically, and in dementia more broadly. The goal of this study is to maximize functional communication and life participation for the participants.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Aphasia
• Aphasia, Primary Progressive
• Frontotemporal Dementia
• Pick Disease of the Brain
• Primary Progressive Aphasia

Intervention

Behavioral:
• Communication Bridge
Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.

Locations

Country	Name	City	State
United States	University of Chicago - American School Building	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
University of Chicago	National Institute on Aging (NIA), Western University, Canada

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Time Frame: 2 assessment time points through study completion, an average of 5 months, including change over time