Skip to main content

Table 2 Overview of study screening and enrollment processes

From: 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

  Who Procedures
Pre-screening interview RA + PT/CP Initial interview with PT/CP. Eligibility criteria reviewed. Verbal consent obtained for medical record review. RA (Research Assistant) works with PT/CP to request medical records.
Medical record review AST To confirm diagnosis and absence of other exclusionary medical indications.
Technology check RA + PT/CP PT/CP complete technology tasks with RA to verify sufficient technology skills and internet bandwidth for study sessions.
Cognitive, sensory systems, and depression screening RA + PT/CP PT/CP complete screening assessment tasks with RA to ensure participants meet eligibility criteria. Screening measures listed in Table 1.
Secondary screening SLP Non-treating SLP meets with dyad to confirm study readiness, PPA-related deficits /severity, and other relevant medical history information.
Screening review and enrollment decision AST The AST and other team members involved in screening process (RA and SLP) review all screening assessment results. AST makes the final decision to enroll through consensus.
Consents/orientation RA + PT/CP REDCap e-consent signature from PT+CP; Orientation to video conferencing platform and Communication Bridge web application. Complete demographic, health history, and questionnaires with PT. CP completes questionnaires independently and mails back to study team.
  1. RA research assistant, PT/CP participant with PPA and their co-enrolled communication partner, SLP speech-language pathologist not involved in delivering interventions who is blinded to trial arm allocation, AST the administrative study team (authors EAS, ACR, and ER)