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NCT Number: NCT06191198

Communication Bridge 3 Study

This study will use a randomized controlled trial design to evaluate the effect of two evidence-based treatments for adults with mild-moderate 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.

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Key information

About this study

Participants with a diagnosis of PPA and their actively-engaged care partners will be involved in the study for approximately 17 months. Each participant will receive a laptop equipped with the necessary applications and features for the study. Participants will receive up to 10 evaluations and 20 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.

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 Participation Person Centered Goals

    Time frame: 5 assessment time points through study completion (up to 18 months)

    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.

  2. Change in Communication Participation

    Time frame: 5 assessment time points through study completion (up to 18 months)

    The CPIB measure is a 10-item, disorder-generic, Likert scale that asks persons to rate how their condition interferes with participating in daily communication activities (e.g., talking to people you know/do not know, securing a turn in a fast-moving conversation). The psychometric properties of the measure have been published previously (Baylor et al., 2013; Baylor et al., 2019). Both raw and T-scores are available. The CPIB T-score has a theoretical mean of 50 and standard deviation of 10 with higher numbers reflecting higher levels of participation in communication activities.

  3. Montgomery Burden Inventory (MBI)

    Time frame: 5 assessment time points through study completion (up to 18 months)

    The MBI is a pen/paper Likert scale with 16 items distributed across three subscales (Montgomery et al., 1985) completed by the care partner. Total and mean item scores are calculated for each of the three subscales: Objective burden is defined as the perceived infringement of disruption of tangible aspects of a caregiver's life; Subjective demand/relational burden is typically described as the extent to which the caregiver perceives that the care recipient is overly demanding in the context of caregiving; Subjective stress burden is the emotional impact of caregiving responsibilities. Participants rate each item with a score between 1 (Not at all) and 5 (A great deal) corresponding to the amount of perceived burden. Higher scores reflect increased burden. Internal consistency .81 to .90. Construct validity demonstrated in mixed cohort of care partners of persons with dementia. Test-retest stability coefficients are robust (ICC of 0.92 to 0.91) (Farley et al., 2010).

Study contacts

Contact information is provided by the study sponsor or research team.

Emily Cummings

CONTACT

[email protected]

773-702-1221

Matthew Bona, MPH

CONTACT

[email protected]

773-702-1220 ext. 51145

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • National Institute on Aging (NIA)
  • Western University, Canada

Registry information

Official study title

Communication Bridge: Optimizing an Evidence-based Intervention for Individuals With Primary Progressive Aphasia

Acronym: CB3

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jan 5, 2024
Registry last updated
Jun 1, 2026

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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