Clinical trial NCT03371706: Communication Bridge 2
Official title: Communication Bridge: A Person-centered Internet-based Intervention for Individuals With Primary Progressive Aphasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Progressive Aphasia
Keywords: aphasia
primary progressive aphasia
dementia
communication
frontotemporal dementia
Alzheimer's disease
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2017-12-13
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: NIH Stage 2 behavioral clinical trial
Primary purpose: TREATMENT

Brief summary: This study will use a randomized controlled trial design to evaluate the effect of two evidence-based treatments for adults with mild Primary Progressive Aphasia (PPA). The aim of the study is to help us better understand the effects of speech language therapy on communication abilities in individuals with PPA.

Participants with a diagnosis of PPA and their actively-engaged care partners will be involved in the study for 12 months. Each participant will receive a laptop equipped with the necessary applications and features for the study. Participants will receive 5 evaluations and 15 speech therapy sessions with a licensed speech therapist, as well as access to Communication Bridge, a personalized web application to practice home exercises that reinforce treatment strategies. There are no costs to participate in this study.


Eligibility criteria: Inclusion Criteria (person with PPA):

1. Meets diagnostic criteria for PPA based on neurologist and supporting medical assessments (extracted from medical records)
2. English as primary language used in daily communication activities (by self-report)
3. Adequate hearing (aided or unaided) for communicating with others in a crowded room (by self-report)
4. Adequate vision (aided or unaided) for reading a newspaper, or other functional materials (by self-report)
5. Able to pass technology screening and demonstrates sufficient knowledge for use of video conference and Communication Bridge™ web application use (with or without training)
6. Geriatric Depression Scale score ≤ 9
7. Mild-moderate PPA informed by a structured interview with a speech-language pathologist and a standardized testing battery.

Inclusion Criteria (Co-enrolled communication partner):

1. 18+ years of age
2. English as primary language used in daily communication activities (by self-report)
3. Adequate hearing (aided or unaided) for communicating with others in a crowded room (by self-report)
4. Able to pass technology screening\* and demonstrates sufficient knowledge for use of video conference and Communication Bridge™ web application use (with or without training)

Exclusion Criteria:

* A dementia diagnosis other than Primary Progressive Aphasia
* Participation is co-enrolled in an outside speech language therapy program during the study course.
* Communication partners will be excluded if they have a pre-existing communication impairment that would affect study participation (e.g., aphasia, dementia)

Medical records will be requested and reviewed to determine eligibility.

Primary outcomes:
measure: Change in Communication Confidence (CCRSA)
timeFrame: 5 assessment time points through study completion - Baseline, Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 months
measure: Change in Communication Participation Item Bank (CPIB)
timeFrame: 5 assessment time points through study completion - Baseline, Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 months
measure: Change in Communication Participation Person Centered Goals
timeFrame: 4 assessment time points through study completion - Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 months
Secondary outcomes:
Other outcomes:
measure: Change in Word Accuracy (Trained Words)
timeFrame: 5 assessment time points through study completion - Baseline, Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 months
measure: Change in Script Accuracy (Trained Scripts)
timeFrame: 5 assessment time points through study completion - Baseline, Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 months
Locations:
city: Chicago
country: United States
facility: The Healthy Aging & Alzheimer's Research Care Center (University of Chicago)
state: Illinois
Study officials:
affiliation: University of Chicago
name: Emily Rogalski, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roberts AC, Rademaker AW, Salley EA, Mooney A, Morhardt D, Fried-Oken M, Weintraub S, Mesulam M, Rogalski E. Communication Bridge-2 (CB2): an NIH Stage 2 randomized control trial of a speech-language intervention for communication impairments in individuals with mild to moderate primary progressive aphasia. Trials. 2022 Jun 13;23(1):487. doi: 10.1186/s13063-022-06162-7.
citation: Mesulam MM, Coventry C, Kuang A, Bigio EH, Mao Q, Flanagan ME, Gefen T, Sridhar J, Geula C, Zhang H, Weintraub S, Rogalski EJ. Memory Resilience in Alzheimer Disease With Primary Progressive Aphasia. Neurology. 2021 Feb 9;96(6):e916-e925. doi: 10.1212/WNL.0000000000011397. Epub 2021 Jan 13.