Communication Bridge 3 Study

Phase 2RecruitingNCT06191198

University of Chicago200 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

200

Conditions

Primary Progressive Aphasia

Interventions

Communication Bridge™BEHAVIORAL

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

Evidence-Based Impairment FocusedBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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) 6. Geriatric Depression Scale score ≤ 9 7. Mild-moderate PPA informed by a structured interview with a speech-language pathologist and a standardized testing battery. Inclusion Criteria (Co-enrolled communication partner): 1. 18+ years of age 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. 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

Locations (1)

University of Chicago - American School Building

Chicago, Illinois, United States

RECRUITING

Outcomes

Primary Outcomes

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.

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

Change in Communication Participation

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.

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

Montgomery Burden Inventory (MBI)

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).

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

Central Contacts

Matthew Bona, MPH

CONTACT

773-702-1220 cbtrial@uchicago.edu

Emily Cummings

CONTACT

773-702-1221 cbtrial@uchicago.edu

Data from ClinicalTrials.gov

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