Communication Bridge 3 Study
ConditionPrimary Progressive Aphasia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity of Chicago
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Communication Bridge™
BehavioralEvidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.
Evidence-Based Impairment Focused
BehavioralEvidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Communication Bridge™Experimental treatment 1 intervention
Group B: Evidence-Based Impairment FocusedActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)2
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)3
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)Sponsors and contacts
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University of Chicago
Lead sponsor
Western University, Canada
Collaborator
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov