Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03371706
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.


Condition or disease Intervention/treatment Phase
Primary Progressive Aphasia Behavioral: Evidence-Based Treatment Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: NIH Stage 2 behavioral clinical trial
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Communication Bridge: A Person-centered Internet-based Intervention for Individuals With Primary Progressive Aphasia
Actual Study Start Date : April 3, 2018
Estimated Primary Completion Date : February 1, 2023
Estimated Study Completion Date : February 1, 2024


Arm Intervention/treatment
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.
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™

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.
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™




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Other Outcome Measures:
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03371706


Contacts
Layout table for location contacts
Contact: Libby Rogers, M.A. 312-503-4012 libbyrogers@northwestern.edu
Contact: Emily Rogalski, Ph.D. 312-503-1155 e-rogalski@northwestern.edu

Locations
Layout table for location information
United States, Illinois
Cognitive Neurology and Alzheimer's Disease Center - Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Libby Rogers, M.A.    312-503-4012    libbyrogers@northwestern.edu   
Contact: Emily Rogalski, Ph.D.    312-503-1155    erogalski@gmail.com   
Principal Investigator: Emily Rogalski, Ph.D.         
Sponsors and Collaborators
Northwestern University
National Institute on Aging (NIA)
Investigators
Layout table for investigator information
Principal Investigator: Emily Rogalski, Ph.D. Northwestern University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Emily Rogalski, Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT03371706    
Other Study ID Numbers: STU00206086
1R01AG055425-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: September 1, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Emily Rogalski, Northwestern University:
aphasia
primary progressive aphasia
dementia
communication
frontotemporal dementia
Alzheimer's disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Aphasia
Aphasia, Primary Progressive
Pick Disease of the Brain
Frontotemporal Dementia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Dementia
Brain Diseases
Central Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Neurodegenerative Diseases
Proteostasis Deficiencies
Metabolic Diseases