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Trial record 1 of 1 for:    NCT03371706
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Communication Bridge: A Person-centered Internet-based Intervention for Individuals With Primary Progressive Aphasia

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ClinicalTrials.gov Identifier: NCT03371706
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : September 1, 2021
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Emily Rogalski, Northwestern University

Tracking Information
First Submitted Date  ICMJE December 8, 2017
First Posted Date  ICMJE December 13, 2017
Last Update Posted Date September 1, 2021
Actual Study Start Date  ICMJE April 3, 2018
Estimated Primary Completion Date February 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2021)
  • Change in Communication Confidence PROM [ Time Frame: 5 assessment time points through study completion, an average of 1 year, including change over time ]
    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.
  • Change in Communication Participation PROM [ Time Frame: 5 assessment time points through study completion, an average of 1 year, including change over time ]
    Communication Participation Item Bank, a 4-point rating scale with 0 representing 'very much' and 3 representing 'not at all'. Higher scores indicate greater severity of communication challenges.
  • Change in Communication Participation Person Centered Goals [ Time Frame: 5 assessment time points through study completion, an average of 1 year, including change over time ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 8, 2017)
Language Performance Measures [ Time Frame: 5 times over the course of the year ]
Accuracy on word training and script training.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: August 26, 2021)
  • Change in Word accuracy (trained words) [ Time Frame: 5 assessment time points through study completion, an average of 1 year, including change over time ]
    Percent accuracy on trained words
  • Change in Script accuracy (trained scripts) [ Time Frame: 5 assessment time points through study completion, an average of 1 year, including change over time ]
    Percent accuracy on trained scripts
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Communication Bridge: A Person-centered Internet-based Intervention for Individuals With Primary Progressive Aphasia
Official Title  ICMJE Communication Bridge: A Person-centered Internet-based Intervention for Individuals With Primary Progressive Aphasia
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
NIH Stage 2 behavioral clinical trial
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Primary Progressive Aphasia
Intervention  ICMJE Behavioral: Evidence-Based Treatment
Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.
Other Name: Communication Bridge™
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Behavioral: Evidence-Based Treatment
  • Active Comparator: 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.
    Intervention: Behavioral: Evidence-Based Treatment
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 8, 2017)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2024
Estimated Primary Completion Date February 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Libby Rogers, M.A. 312-503-4012 libbyrogers@northwestern.edu
Contact: Emily Rogalski, Ph.D. 312-503-1155 e-rogalski@northwestern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03371706
Other Study ID Numbers  ICMJE STU00206086
1R01AG055425-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Analytic Code
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. Informed Consent Form available immediately
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.
Responsible Party Emily Rogalski, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: Emily Rogalski, Ph.D. Northwestern University
PRS Account Northwestern University
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP