Communication Bridge-2 randomized controlled trial: Recruitment and baseline features.

Area of Science:

• Neurology
• Speech-Language Pathology
• Clinical Trials

Background:

• Primary progressive aphasia (PPA) significantly impairs communication and quality of life for individuals and their care partners.
• Efficacy trials for non-pharmacological interventions in PPA are lacking, creating a need for feasibility studies.
• The Communication Bridge-2 (CB2) trial addresses this gap by assessing the feasibility of a novel intervention delivery method.

Purpose of the Study:

• To evaluate the feasibility of recruitment, enrollment, randomization, and baseline data collection for the Communication Bridge-2 (CB2) randomized controlled trial (RCT).
• To establish a model for conducting rigorous non-pharmacological efficacy trials for PPA and related dementias via telemedicine.

Main Methods:

• CB2 is the first international, Phase 2, Stage 2, parallel-group, active-controlled RCT delivered via video chat.
• Participants were recruited, screened, and randomized into one of two speech-language intervention arms.
• Ninety-five participant dyads (individuals with PPA and their care partners) from four countries were enrolled.

Main Results:

• Global recruitment, enrollment, and randomization of PPA participant dyads into the CB2 RCT were feasible.
• The study successfully enrolled 95 dyads, with a mean baseline age of 67.1 years (48% female).
• The trial demonstrated the viability of using video chat for delivering non-pharmacological interventions in PPA.

Conclusions:

• Telemedicine-delivered non-pharmacological RCTs are feasible for individuals with PPA.
• The CB2 trial provides a successful model for conducting rigorous efficacy studies for PPA and other neurodegenerative conditions like Alzheimer's disease.
• This approach has the potential to improve communication participation and quality of life for those affected by PPA.