- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02439853
Communication Bridge Speech Therapy Research Study
November 8, 2022 updated by: Emily Rogalski, Northwestern University
Communication Bridge Speech Therapy Research Study: Using Internet-Based Speech Therapy to Improve Quality of Life and Access to Care
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The purpose of this study is:
- 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.
- To identify the most effective speech and language therapy strategies for persons with these conditions.
- 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
Enrollment (Actual)
57
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / 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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Change from baseline assessment at 2-months, 6-months and 12-months post-treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Emily J Rogalski, PhD, Northwestern University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (ACTUAL)
December 1, 2019
Study Completion (ACTUAL)
January 1, 2020
Study Registration Dates
First Submitted
April 23, 2015
First Submitted That Met QC Criteria
May 11, 2015
First Posted (ESTIMATE)
May 12, 2015
Study Record Updates
Last Update Posted (ACTUAL)
November 9, 2022
Last Update Submitted That Met QC Criteria
November 8, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Neurodegenerative Diseases
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Neurodevelopmental Disorders
- Language Disorders
- Speech Disorders
- Frontotemporal Lobar Degeneration
- Dementia
- Aphasia
- Frontotemporal Dementia
- Aphasia, Primary Progressive
- Pick Disease of the Brain
- Communication Disorders
Other Study ID Numbers
- STU00073634
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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