Communication Bridge 2

Browse trials for

• Aphasia, Primary Progressive 77
• Aphasia 338
• Dementia 2,372
• Communication 719
• Frontotemporal Dementia 208
• Alzheimer Disease 3,965

Keywords

• aphasia
• primary progressive aphasia
• dementia
• communication
• frontotemporal dementia
• Alzheimer's disease

Aphasia, Primary Progressive

77 studies on the registry are indexed under Aphasia, Primary Progressive; 29 are open to participants now.

This study's enrollment of 190 is above the median of 30 across 60 interventional studies indexed under Aphasia, Primary Progressive.

Lead sponsor

University of Chicago is the lead sponsor of 924 studies on the registry; 185 are open to participants now.

Of its 103 completed or terminated interventional studies of FDA-regulated products, 72 (70%) have results posted.

Study arms

• 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™

• Active comparator
  Evidence-Based Impairment Focused

  The Control arm includes a non-dyadic intervention in which the person with PPA is the active intervention recipient and their communication partner is in a supporting role. In the Control arm, participants receive a speech-language intervention designed to address impairment and functional limitations, comprised of activities that address word retrieval and 'automatic' speech production using fixed, non-personalized, stimuli across participants.

  Behavioral: Evidence-Based Impairment Focused

Interventions

• BehavioralCommunication Bridge™

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

• BehavioralEvidence-Based Impairment Focused

  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)

   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.

   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

2. Change in Communication Participation Item Bank (CPIB)

   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

   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

3. Change in Communication Participation Person Centered Goals

   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.

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

Other outcomes

1. Change in Word Accuracy (Trained Words)

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

   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

2. Change in Script Accuracy (Trained Scripts)

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

   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

Baseline characteristics

Publications

• Roberts AC, Rademaker AW, Salley EA, Mooney A, Morhardt D, Fried-Oken M, Weintraub S, Mesulam M, Rogalski E. Communication Bridge-2 (CB2): an NIH Stage 2 randomized control trial of a speech-language intervention for communication impairments in individuals with mild to moderate primary progressive aphasia. Trials. 2022 Jun 13;23(1):487. doi: 10.1186/s13063-022-06162-7. PubMed 35698099 ↗
• Mesulam MM, Coventry C, Kuang A, Bigio EH, Mao Q, Flanagan ME, Gefen T, Sridhar J, Geula C, Zhang H, Weintraub S, Rogalski EJ. Memory Resilience in Alzheimer Disease With Primary Progressive Aphasia. Neurology. 2021 Feb 9;96(6):e916-e925. doi: 10.1212/WNL.0000000000011397. Epub 2021 Jan 13. PubMed 33441454 ↗

Study documents

• Protocol and statistical analysis plan ↗ · Jul 3, 2023

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan

Time frame: Publication of study protocol manuscript prior to enrolling final participant. Communication Bridge Manual of Procedures upon publication of study protocol or when final participant completes all study procedures (whichever comes later). Statistical Analysis Plan to be published with study protocol.

Access criteria: With approval of study administration team, with the exception of documents that will be made available to the public following study completion (manual of procedures). Analyzed and processed data will be available by request with an approved Collaborator Agreement.