Communication Bridge 2

NCT03371706 | Completed Results DMC

• 2 other identifiers: IRB23-13341R01AG055425-01A1
• Study Type: interventional
• Target: 190
• 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 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. 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 laptop equipped with the necessary applications and features for the study. Participants will receive 5 evaluations and 15 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

Keywords

aphasia; primary progressive aphasia; dementia; communication; frontotemporal dementia; Alzheimer's disease

Outcome Measures

Primary Outcomes (3)

• 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.

  5 assessment time points through study completion - Baseline, Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 months

• Change in Communication Participation Item Bank (CPIB)

  Communication Participation Item Bank is a 4-point rating scale with 0 representing 'very much' and 3 representing 'not at all'. Higher scores indicate greater severity of communication challenges. We are reporting on change in CPIB scores using T-scores. The Communicative Participation Item Bank (CPIB) T-score range is as follows: T57.5 and above: Represents a "normal" experience of communicative participation or "minimal problems" T57.5-T45: Represents mild challenges T45-T35: Represents moderate challenges T35 and below: Represents severe challenges The CPIB is a patient-reported instrument that measures communicative participation. The mean T-score is 50, and the standard deviation is 10. Higher scores are more favorable, indicating less interference in participation. The ideal score, or someone who reports no problems with communicative participation, would be a T-score of 74.3

  5 assessment time points through study completion - Baseline, Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 months

• Change in Communication Participation Person Centered Goals

  This measure assesses progress toward communication participation goals using Goal Attainment Scaling (GAS). Participants developed personalized goals, each set to a baseline value of '0'. Progress was tracked using a 7-point scale, where -3 represents 'no longer participating' and +3 represents 'exceeded goal'. Higher scores indicate better progress toward goal achievement. Goals were evaluated at 3, 6, 9, and 12 months, with the results reported as the percentage of goals that: Worsened (scores of -1, -2, or -3) No change (score remained at 0) Improved (scores of +1, +2, or +3), including getting close to, reaching, or exceeding the goal. The table below presents the percentage of goals falling into each of these categories at each assessment point.

  4 assessment time points through study completion - Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 months

Other Outcomes (2)

• Change in Word Accuracy (Trained Words)

  5 assessment time points through study completion - Baseline, Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 months

• Change in Script Accuracy (Trained Scripts)

  5 assessment time points through study completion - Baseline, Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 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
• 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

Related Publications (2)

• Roberts AC, Rademaker AW, Salley EA, Mooney A, Morhardt D, Fried-Oken M, Weintraub S, Mesulam M, Rogalski E. Communication Bridge-2 (CB2): an NIH Stage 2 randomized control trial of a speech-language intervention for communication impairments in individuals with mild to moderate primary progressive aphasia. Trials. 2022 Jun 13;23(1):487. doi: 10.1186/s13063-022-06162-7.

  PMID: 35698099 DERIVED

• Mesulam MM, Coventry C, Kuang A, Bigio EH, Mao Q, Flanagan ME, Gefen T, Sridhar J, Geula C, Zhang H, Weintraub S, Rogalski EJ. Memory Resilience in Alzheimer Disease With Primary Progressive Aphasia. Neurology. 2021 Feb 9;96(6):e916-e925. doi: 10.1212/WNL.0000000000011397. Epub 2021 Jan 13.

  PMID: 33441454 DERIVED

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

Results Point of Contact

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

emily.rogalski@bsd.uchicago.edu

855-824-7887

Study Officials

• Emily Rogalski, Ph.D.

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• 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 8, 2017
• First Posted: December 13, 2017
• Study Start: April 3, 2018
• Primary Completion: March 23, 2023
• Study Completion: March 23, 2023
• Last Updated: October 17, 2024
• Results First Posted: October 17, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Publication of study protocol manuscript prior to enrolling final participant. Communication Bridge Manual of Procedures upon publication of study protocol or when final participant completes all study procedures (whichever comes later). Statistical Analysis Plan to be published with study protocol.
• Access Criteria: With approval of study administration team, with the exception of documents that will be made available to the public following study completion (manual of procedures). Analyzed and processed data will be available by request with an approved Collaborator Agreement.

Locations

US (1)