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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 : July 2, 2020
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 July 2, 2020
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: December 8, 2017)
Language Performance Measures [ Time Frame: 5 times over the course of the year ]
Accuracy on word training and script training.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
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 and compensation will be provided.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Study Arms  ICMJE
  • Experimental: Evidence-Based Treatment 1
    Intervention: Behavioral: Evidence-Based Treatment
  • Active Comparator: Evidence-Based Treatment 2
    Intervention: Behavioral: Evidence-Based Treatment
Publications * Not Provided

*   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:

  • Diagnosis of PPA (with mild impairment)
  • Communication partner (e.g. spouse, family member) who is willing to participate
  • Adequate experience with computers and sufficient Internet connection
  • English speaking

Exclusion Criteria:

  • A dementia diagnosis other than Primary Progressive Aphasia
  • Participation in outside speech language therapy during the course of the 1-year study

Medical records will be requested and reviewed by the study doctors to determine eligibility. Additionally, a technology screening will be administered to determine comfort level with computers.

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: Undecided
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 June 2020

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