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Completed

NCT Number: NCT03371706

Communication Bridge 2

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.

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Key information

Conditions

Primary Progressive Aphasia Alzheimer Disease Aphasia Aphasia, Primary Progressive Behavior Brain Diseases Central Nervous System Diseases Communication Communication Disorders Dementia Frontotemporal Dementia Frontotemporal Lobar Degeneration Language Disorders Mental Disorders Metabolic Diseases Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Proteostasis Deficiencies Signs and Symptoms Speech Disorders TDP-43 Proteinopathies Tauopathies

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Healthy Aging & Alzheimer's Research Care Center (University of Chicago)

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Communication Bridge™

Behavioral

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

Evidence-Based Impairment Focused

Behavioral

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

Primary outcomes

  1. Change in Communication Confidence (CCRSA)

    Time frame: 5 assessment time points through study completion - Baseline, Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 months

    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.

  2. Change in Communication Participation Item Bank (CPIB)

    Time frame: 5 assessment time points through study completion - Baseline, Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 months

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

    We are reporting on change in CPIB scores using T-scores. The Communicative Participation Item Bank (CPIB) T-score range is as follows:

    T57.5 and above: Represents a "normal" experience of communicative participation or "minimal problems" T57.5-T45: Represents mild challenges T45-T35: Represents moderate challenges T35 and below: Represents severe challenges

    The CPIB is a patient-reported instrument that measures communicative participation. The mean T-score is 50, and the standard deviation is 10. Higher scores are more favorable, indicating less interference in participation. The ideal score, or someone who reports no problems with communicative participation, would be a T-score of 74.3

  3. Change in Communication Participation Person Centered Goals

    Time frame: 4 assessment time points through study completion - Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 months

    This measure assesses progress toward communication participation goals using Goal Attainment Scaling (GAS). Participants developed personalized goals, each set to a baseline value of '0'. Progress was tracked using a 7-point scale, where -3 represents 'no longer participating' and +3 represents 'exceeded goal'. Higher scores indicate better progress toward goal achievement. Goals were evaluated at 3, 6, 9, and 12 months, with the results reported as the percentage of goals that:

    Worsened (scores of -1, -2, or -3) No change (score remained at 0) Improved (scores of +1, +2, or +3), including getting close to, reaching, or exceeding the goal.

    The table below presents the percentage of goals falling into each of these categories at each assessment point.

Other outcomes

  1. Change in Word Accuracy (Trained Words)

    Time frame: 5 assessment time points through study completion - Baseline, Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 months

    proportion of participants accuracy on trained words. Higher values indicate greater number of words produced after first prompt. Range 0 - 30

  2. Change in Script Accuracy (Trained Scripts)

    Time frame: 5 assessment time points through study completion - Baseline, Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 months

    proportion of participants accuracy on trained scripts. Higher values indicate greater level of script performance as a proportion. Range 0 - 1.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: CB2

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Dec 13, 2017
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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