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CB3 Pilot (Communication Bridge: A Person-centered Internet-based Intervention for Individuals With Primary Progressive Aphasia) (CB3 Pilot)

Primary Purpose

Aphasia, Primary Progressive Aphasia, Dementia

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Communication Bridge™
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria (person with PPA): Meets diagnostic criteria for PPA based on neurologist and supporting medical assessments (extracted from medical records) English as primary language used in daily communication activities (by self-report) Adequate hearing (aided or unaided) for communicating with others in a crowded room (by self-report) Adequate vision (aided or unaided) for reading a newspaper, or other functional materials (by self-report) 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 may be requested and reviewed to determine eligibility.

Sites / Locations

  • Mesulam Center for Cognitive Neurology & Alzheimer's Disease

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: Communication Bridge™

Arm Description

Participants receive Communication Bridge™, a multi-component, participation-focused, dyadic intervention in which both the person with PPA and their co-enrolled communication partner are intervention recipients. Communication Bridge™ is modelled on the Living with Aphasia: Framework for Outcome Measurement (A-FROM) and the Care Pathway Model that was developed for persons living with primary progressive aphasia. Consistent with participation-focused intervention models personally salient training stimuli are incorporated into all therapy activities in the Experimental arm.

Outcomes

Primary Outcome Measures

Change in Communication Confidence PROM
Communication Confidence Rating Scale in Aphasia, a 0-100 numeric rating scale with 0 representing 'not confident' and 100 representing 'very confident'. Higher scores indicate greater confidence.

Secondary Outcome Measures

Full Information

First Posted
January 10, 2023
Last Updated
September 18, 2023
Sponsor
Northwestern University
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT05697380
Brief Title
CB3 Pilot (Communication Bridge: A Person-centered Internet-based Intervention for Individuals With Primary Progressive Aphasia)
Acronym
CB3 Pilot
Official Title
Communication Bridge: A Person-centered Internet-based Intervention for Individuals With Primary Progressive Aphasia 3.0 Pilot
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will evaluate evidence-based treatments for adults with mild Primary Progressive Aphasia (PPA). The aim of the study is to help identify efficacious communication and quality of life interventions for those with PPA and their care-partners. 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 iPad equipped with the necessary applications and features for the study. Participants will complete evaluations, speech therapy sessions with a speech and language therapist, and sessions with a licensed social worker or related clinician. They will have 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.
Detailed Description
This study will evaluate evidence-based treatments for adults with mild Primary Progressive Aphasia (PPA). The aim of the study is to help identify efficacious communication and quality of life interventions for those with PPA and their care-partners. 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 iPad equipped with the necessary applications and features for the study. Participants will complete evaluations, speech therapy sessions with a speech and language therapist, and sessions with a licensed social worker or related clinician. They will have 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Primary Progressive Aphasia, Dementia, Communication, Alzheimer Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Communication Bridge™
Arm Type
Experimental
Arm Description
Participants receive Communication Bridge™, a multi-component, participation-focused, dyadic intervention in which both the person with PPA and their co-enrolled communication partner are intervention recipients. Communication Bridge™ is modelled on the Living with Aphasia: Framework for Outcome Measurement (A-FROM) and the Care Pathway Model that was developed for persons living with primary progressive aphasia. Consistent with participation-focused intervention models personally salient training stimuli are incorporated into all therapy activities in the Experimental arm.
Intervention Type
Behavioral
Intervention Name(s)
Communication Bridge™
Intervention Description
Evidence-based speech language therapy treatment will be compared and contrasted.
Primary Outcome Measure Information:
Title
Change in Communication Confidence PROM
Description
Communication Confidence Rating Scale in Aphasia, a 0-100 numeric rating scale with 0 representing 'not confident' and 100 representing 'very confident'. Higher scores indicate greater confidence.
Time Frame
Time Frame: 5 assessment time points through study completion, an average of 1 year, including change over time

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria (person with PPA): Meets diagnostic criteria for PPA based on neurologist and supporting medical assessments (extracted from medical records) English as primary language used in daily communication activities (by self-report) Adequate hearing (aided or unaided) for communicating with others in a crowded room (by self-report) Adequate vision (aided or unaided) for reading a newspaper, or other functional materials (by self-report) 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 may be requested and reviewed to determine eligibility.
Facility Information:
Facility Name
Mesulam Center for Cognitive Neurology & Alzheimer's Disease
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Learn more about this trial

CB3 Pilot (Communication Bridge: A Person-centered Internet-based Intervention for Individuals With Primary Progressive Aphasia)

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