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

Primary Purpose

Primary Progressive Aphasia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Communication Bridge™

Evidence-Based Impairment Focused

About this trial

This is an interventional treatment trial for Primary Progressive Aphasia focused on measuring aphasia, primary progressive aphasia, dementia, communication, frontotemporal dementia, Alzheimer's disease

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)
Geriatric Depression Scale score ≤ 9
Mild-moderate PPA informed by a structured interview with a speech-language pathologist and a standardized testing battery.

Inclusion Criteria (Co-enrolled communication partner):

18+ years of age
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)
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.

Sites / Locations

Mesulam Center for Cognitive Neurology and Alzheimer's Disease - Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Communication Bridge™

Evidence-Based Impairment Focused

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.

The Control arm includes a non-dyadic intervention in which the person with PPA is the active intervention recipient and their communication partner is in a supporting role. In the Control arm, participants receive a speech-language intervention designed to address impairment and functional limitations, comprised of activities that address word retrieval and 'automatic' speech production using fixed, non-personalized, stimuli across participants.

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.

Change in Communication Participation PROM

Communication Participation Item Bank, a 4-point rating scale with 0 representing 'very much' and 3 representing 'not at all'. Higher scores indicate greater severity of communication challenges.

Change in Communication Participation Person Centered Goals

Goal Attainment Scaling, a 7-point rating scale with -3 representing 'no longer participating' and +3 representing 'exceeded goal'. Higher scores indicate better progress in goal achievement.

Secondary Outcome Measures

Full Information

NCT ID

NCT03371706

First Posted

December 8, 2017

Last Updated

June 27, 2023

Sponsor

Northwestern University

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT03371706

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

April 3, 2018 (Actual)

Primary Completion Date

March 23, 2023 (Actual)

Study Completion Date

March 23, 2023 (Actual)

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Progressive Aphasia

Keywords

aphasia, primary progressive aphasia, dementia, communication, frontotemporal dementia, Alzheimer's disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

NIH Stage 2 behavioral clinical trial

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

95 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Communication Bridge™

Arm Type

Experimental

Arm Description

Arm Title

Evidence-Based Impairment Focused

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Communication Bridge™

Intervention Description

Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.

Intervention Type

Behavioral

Intervention Name(s)

Evidence-Based Impairment Focused

Intervention Description

Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.

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

5 assessment time points through study completion, an average of 1 year, including change over time

Title

Change in Communication Participation PROM

Description

Communication Participation Item Bank, a 4-point rating scale with 0 representing 'very much' and 3 representing 'not at all'. Higher scores indicate greater severity of communication challenges.

Time Frame

5 assessment time points through study completion, an average of 1 year, including change over time

Title

Change in Communication Participation Person Centered Goals

Description

Goal Attainment Scaling, a 7-point rating scale with -3 representing 'no longer participating' and +3 representing 'exceeded goal'. Higher scores indicate better progress in goal achievement.

Time Frame

5 assessment time points through study completion, an average of 1 year, including change over time

Other Pre-specified Outcome Measures:

Title

Change in Word accuracy (trained words)

Description

Percent accuracy on trained words

Time Frame

5 assessment time points through study completion, an average of 1 year, including change over time

Title

Change in Script accuracy (trained scripts)

Description

Percent accuracy on trained scripts

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

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) Geriatric Depression Scale score ≤ 9 Mild-moderate PPA informed by a structured interview with a speech-language pathologist and a standardized testing battery. Inclusion Criteria (Co-enrolled communication partner): 18+ years of age 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) 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Emily Rogalski, Ph.D.

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mesulam Center for Cognitive Neurology and Alzheimer's Disease - Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Time Frame

Publication of study protocol manuscript prior to enrolling final participant. Communication Bridge Manual of Procedures upon publication of study protocol or when final participant completes all study procedures (whichever comes later). Statistical Analysis Plan to be published with study protocol. Informed Consent Form available immediately

IPD Sharing Access Criteria

With approval of study administration team, with the exception of documents that will be made available to the public following study completion (manual of procedures). Analyzed and processed data will be available by request with an approved Collaborator Agreement.

Citations:

PubMed Identifier

35698099

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.

Results Reference

derived

PubMed Identifier

33441454

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.

Results Reference

derived

Learn more about this trial

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

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