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Communication Bridge Speech Therapy Research Study

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ClinicalTrials.gov Identifier: NCT02439853
Recruitment Status : Active, not recruiting
First Posted : May 12, 2015
Last Update Posted : June 13, 2018
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

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.

Condition or disease Intervention/treatment Phase
Primary Progressive Aphasia Frontotemporal Dementia Behavioral: Monthly Check-in Session Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Communication Bridge Speech Therapy Research Study: Using Internet-Based Speech Therapy to Improve Quality of Life and Access to Care
Study Start Date : March 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2021


Arm Intervention/treatment
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.
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.

No Intervention: Control Arm
Subjects in the Control arm will not undergo three check-in sessions with the speech therapist.



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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): NCT02439853


Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Alzheimer's Association
The Association for Frontotemporal Degeneration
Illinois Department of Public Health
National Institutes of Health (NIH)
Investigators
Principal Investigator: Emily J Rogalski, PhD Northwestern University

Responsible Party: Emily Rogalski, Associate Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT02439853     History of Changes
Other Study ID Numbers: STU00073634
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018

Keywords provided by Emily Rogalski, Northwestern University:
primary progressive aphasia
progressive nonfluent aphasia
progressive aphasia
frontotemporal dementia
frontotemporal lobar degeneration

Additional relevant MeSH terms:
Frontotemporal Dementia
Pick Disease of the Brain
Dementia
Aphasia
Aphasia, Primary Progressive
Communication Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Speech Disorders
Language Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Neurodegenerative Diseases
Proteostasis Deficiencies
Metabolic Diseases
Neurodevelopmental Disorders