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Communication Bridge Speech Therapy Research Study

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02439853
Recruitment Status : Active, not recruiting
First Posted : May 12, 2015
Last Update Posted : June 21, 2019
Sponsor:
Collaborators:
Alzheimer's Association
The Association for Frontotemporal Degeneration
Illinois Department of Public Health
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Emily Rogalski, Northwestern University

Tracking Information
First Submitted Date  ICMJE April 23, 2015
First Posted Date  ICMJE May 12, 2015
Last Update Posted Date June 21, 2019
Study Start Date  ICMJE March 2013
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2015)
Assessment of Functional Communication Abilities [ Time Frame: Change from baseline assessment at 2-months, 6-months and 12-months post-treatment ]
Functional Communication Abilities will be assessed through questionnaires about the participant's language and communication, neuropsychological testing, and speech and language therapy evaluations.
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 Speech Therapy Research Study
Official Title  ICMJE Communication Bridge Speech Therapy Research Study: Using Internet-Based Speech Therapy to Improve Quality of Life and Access to Care
Brief Summary This is a study on Internet-based video-practice speech and language therapy for persons with primary progressive aphasia (PPA), behavioral-variant frontotemporal dementia (bvFTD), or related conditions.
Detailed Description

The purpose of this study is:

  1. To evaluate the effectiveness of speech and language therapy on a person's ability to communicate immediately after treatment, 6-months after treatment, and 12-months after treatment.
  2. To identify the most effective speech and language therapy strategies for persons with these conditions.
  3. To determine the feasibility of Internet-based video-practice of speech and language therapy for persons with these conditions.

The study will involve 12 to 15 session over the course of 12 months. Some of these sessions will be in-person at the Northwestern Cognitive Neurology and Alzheimer's Disease Center (Chicago, IL), while others will take place over the Internet, using an online study portal.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Primary Progressive Aphasia
  • Frontotemporal Dementia
Intervention  ICMJE Behavioral: Monthly Check-in Session
Subjects in the Check-In group will have an online session with a speech-language pathologist 3-, 4-, and 5-months from the subject's enrollment date.
Study Arms  ICMJE
  • Experimental: Check-In group
    Subjects in the Check-In group will undergo three check-in sessions with the speech therapist. These sessions will happen remotely, via video-chat, and will last less than an hour. They will occur at 3-, 4-, and 5-months from the subject's enrollment date.
    Intervention: Behavioral: Monthly Check-in Session
  • No Intervention: Control Arm
    Subjects in the Control arm will not undergo three check-in sessions with the speech therapist.
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 14, 2017)
57
Original Estimated Enrollment  ICMJE
 (submitted: May 11, 2015)
40
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of dementia with language as a primary symptom (i.e. aphasia)
  • An informant who knows the participant well and can answer questions the participant's communication ability
  • Adequate hearing to follow conversation (correction permitted)
  • Adequate vision (correction permitted)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02439853
Other Study ID Numbers  ICMJE STU00073634
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Emily Rogalski, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE
  • Alzheimer's Association
  • The Association for Frontotemporal Degeneration
  • Illinois Department of Public Health
  • National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Emily J Rogalski, PhD Northwestern University
PRS Account Northwestern University
Verification Date June 2019

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