Communication Bridge Speech Therapy Research Study
Primary Purpose
Primary Progressive Aphasia, Frontotemporal Dementia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Monthly Check-in Session
Sponsored by
About this trial
This is an interventional supportive care trial for Primary Progressive Aphasia focused on measuring primary progressive aphasia, progressive nonfluent aphasia, progressive aphasia, frontotemporal dementia, frontotemporal lobar degeneration
Eligibility 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)
Sites / Locations
- Northwestern University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Check-In group
Control Arm
Arm Description
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 Control arm will not undergo three check-in sessions with the speech therapist.
Outcomes
Primary Outcome Measures
Assessment of Functional Communication Abilities
Functional Communication Abilities will be assessed through questionnaires about the participant's language and communication, neuropsychological testing, and speech and language therapy evaluations.
Secondary Outcome Measures
Full Information
NCT ID
NCT02439853
First Posted
April 23, 2015
Last Updated
November 8, 2022
Sponsor
Northwestern University
Collaborators
Alzheimer's Association, The Association for Frontotemporal Degeneration, Illinois Department of Public Health, National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT02439853
Brief Title
Communication Bridge Speech Therapy Research Study
Official Title
Communication Bridge Speech Therapy Research Study: Using Internet-Based Speech Therapy to Improve Quality of Life and Access to Care
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
January 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Alzheimer's Association, The Association for Frontotemporal Degeneration, Illinois Department of Public Health, National Institutes of Health (NIH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Progressive Aphasia, Frontotemporal Dementia
Keywords
primary progressive aphasia, progressive nonfluent aphasia, progressive aphasia, frontotemporal dementia, frontotemporal lobar degeneration
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Check-In group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Subjects in the Control arm will not undergo three check-in sessions with the speech therapist.
Intervention Type
Behavioral
Intervention Name(s)
Monthly Check-in Session
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessment of Functional Communication Abilities
Description
Functional Communication Abilities will be assessed through questionnaires about the participant's language and communication, neuropsychological testing, and speech and language therapy evaluations.
Time Frame
Change from baseline assessment at 2-months, 6-months and 12-months post-treatment
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily J Rogalski, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Communication Bridge Speech Therapy Research Study
We'll reach out to this number within 24 hrs