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

Sponsor
Northwestern University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05697380
Collaborator
National Institute on Aging (NIA) (NIH)
30
1
17

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Communication Bridge™
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Communication Bridge: A Person-centered Internet-based Intervention for Individuals With Primary Progressive Aphasia 3.0 Pilot
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental: Communication Bridge™

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.

Behavioral: Communication Bridge™
Evidence-based speech language therapy treatment will be compared and contrasted.

Outcome Measures

Primary Outcome Measures

  1. Change in Communication Confidence PROM [Time Frame: 5 assessment time points through study completion, an average of 1 year, including change over time]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Northwestern University
  • National Institute on Aging (NIA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Emily Rogalski, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier:
NCT05697380
Other Study ID Numbers:
  • STU00214098
  • 2R56AG055425-06
First Posted:
Jan 25, 2023
Last Update Posted:
Jan 25, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 25, 2023