Primary Progressive AphasiaCBNCT02439853
Communication Bridge Speech Therapy Research Study
A study testing Monthly Check-in Session in people with Primary Progressive Aphasia and Frontotemporal Dementia, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Progressive Aphasia, Frontotemporal Dementia
- What is being tested?
- Monthly Check-in Session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Monthly Check-in Session
- Keywords
- primary progressive aphasia, progressive nonfluent aphasia, progressive aphasia, frontotemporal dementia, frontotemporal lobar degeneration
- Medical subject headings
- Aphasia, Primary Progressive, Frontotemporal Dementia, Primary Progressive Nonfluent Aphasia, Aphasia, Frontotemporal Lobar Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monthly Check-in SessionBehavioural
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 group | Role | What they receive |
|---|---|---|
| Check-In group | Experimental | 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. Receives: Behavioral: Monthly Check-in Session |
| Control Arm | No intervention | Subjects in the Control arm will not undergo three check-in sessions with the speech therapist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline assessment at 2-months, 6-months and 12-months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startMar 2013
- Primary completionDec 2019
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Progressive AphasiaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Association, The Association for Frontotemporal Degeneration, Illinois Department of Public Health, National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Emily J Rogalski, PhD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02439853
- Sponsor's protocol ID
- IRB23-1336
- Acronym
- CB
- Status last verified
- Sep 2024
- First submitted
- 23 Apr 2015
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communication Bridge Speech Therapy Research Study: Using Internet-Based Speech Therapy to Improve Quality of Life and Access to Care
- ClinicalTrials.gov ID
- NCT02439853
- Acronym / sponsor ID
- CB / IRB23-1336
- Keywords
- primary progressive aphasia, progressive nonfluent aphasia, progressive aphasia, frontotemporal dementia, frontotemporal lobar degeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Alzheimer's Association, The Association for Frontotemporal Degeneration, Illinois Department of Public Health, National Institutes of Health (NIH)
- Study start
- Mar 2013
- Primary completion
- Dec 2019 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Check-In group | Experimental | Behavioral: Monthly Check-in SessionSubjects 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. |
| Control Arm | No intervention | –Subjects in the Control arm will not undergo three check-in sessions with the speech therapist. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monthly Check-in SessionSubjects 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. | Behavioural | Check-In group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily J Rogalski, PhD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monthly Check-in Session in people with Primary Progressive Aphasia and Frontotemporal Dementia, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Functional Communication Abilities (time frame: Change from baseline assessment at 2-months, 6-months and 12-months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.