TY - JOUR
T1 - Communication Bridge™-2 (CB2)
T2 - an NIH Stage 2 randomized control trial of a speech-language intervention for communication impairments in individuals with mild to moderate primary progressive aphasia
AU - Roberts, Angela C.
AU - Rademaker, Alfred W.
AU - Salley, Elizabeth Ann
AU - Mooney, Aimee
AU - Morhardt, Darby
AU - Fried-Oken, Melanie
AU - Weintraub, Sandra
AU - Mesulam, Marsel
AU - Rogalski, Emily
N1 - Funding Information:
The authors wish to acknowledge the contributions of the following individuals who are integral to the success of the CB2 trial and/or assisted with the manuscript development process. Acknowledged persons are presented in alphabetical order, which does not reflect their relative contributions to the CB2 trial. Erin Blaze, M.S., CCC-SLP, for her contributions to the enactment of the study protocol including the participant screening process and development of the SLP screening interview procedures. Marissa Esparza, for her invaluable contributions to the enactment of the study protocol and day-to-day study management activities including enactment and monitoring of the study fidelity plan, scoring of outcome measures, protocol manual development, among other key trial activities Rebecca Khayum, M.S., CCC-SLP, for her invaluable contributions to the original Communication Bridge™ intervention concept and the foundational intervention framework. Becky is also acknowledged for her role as a treating speech-language pathology interventionist in our pilot study (CB1) and in the early days of the CB2 trial. Leela Rao, M.S., CCC-SLP, for her role as a treating speech-language pathology interventionist in the CB2 trial and for her significant and invaluable contributions to the study protocol and manual. Haylie Santos, for her tireless assistance with the manuscript preparation and editing. Marie Saxon, M.S., CCC-SLP, for her pivotal role in the CB1 pilot study and for her contributions to the CB2 protocol and study manual. Zoe May Sweeney, for her role in day-to-day study management activities including participant screening, fidelity enactment, participant scheduling, among other key trial activities CB2 trial participants, without whose time and dedication the trial would not be possible. The authors read and approved the final manuscript. Authors ACR, ER, AWR, EAS, AM, and MF-O were involved in the conceptualization of the trial design and the development of the study protocol. Author AWR is responsible for the statistical analysis plan, supported by authors ACR and ER. Authors ACR, ER, AWR, and EAS were responsible for drafting the initial manuscript and provided edits on subsequent versions. Authors AM, MF-O, DM, MM, and SW provided influential editing comments to the manuscript drafts. The CB2 trial reported in this publication was supported by the National Institute on Aging (NIA) of the National Institutes of Health under Award Number R01AG055425 (author ER, PI). Other aspects of the research were supported in part by awards from the NIA R01AG056258, P30AG13854, National Institute of Neurologic Disorders and Stroke (NINDS) R01NS075075, National Institute of Deafness and Other Communication Disorders (NIDCD) R01DC008552, and National Center for Advancing Translational Sciences (NCATS) 5UL1TR001422. National Institute of Deafness and Other Communication Disorders (NIDCD) 1R21DC017255-01. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Key study investigators will have access to the final CB2 trial dataset. Trial data will be made available to non-study investigators following approval of a collaborative request agreement. Collaborative request agreements will require the investigator to secure a separate ethics approval for data use through their home institution and that is compliant with the data use and sharing procedures consented to by participants and the Northwestern University IRB. Contractual agreements for data sharing will be executed between Northwestern University and the requesting investigator’s home institution. Study-related materials and protocol manuals will be made available to the scientific community via links provided in this manuscript.
Funding Information:
The CB2 trial reported in this publication was supported by the National Institute on Aging (NIA) of the National Institutes of Health under Award Number R01AG055425 (author ER, PI). Other aspects of the research were supported in part by awards from the NIA R01AG056258, P30AG13854, National Institute of Neurologic Disorders and Stroke (NINDS) R01NS075075, National Institute of Deafness and Other Communication Disorders (NIDCD) R01DC008552, and National Center for Advancing Translational Sciences (NCATS) 5UL1TR001422. National Institute of Deafness and Other Communication Disorders (NIDCD) 1R21DC017255-01. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Publisher Copyright:
© 2022, The Author(s).
PY - 2022/12
Y1 - 2022/12
N2 - Background: Primary progressive aphasia (PPA) is a clinical dementia syndrome. Impairments in language (speaking, reading, writing, and understanding) are the primary and persistent symptoms. These impairments progress insidiously and devastate communication confidence, participation, and quality of life for persons living with PPA. Currently, there are no effective disease modifying treatments for PPA. Speech-language interventions hold promise for mitigating communication challenges and language symptoms. However, evidence regarding their efficacy in PPA is of low quality and there are currently no rigorous randomized trials. Method: Communication Bridge™-2 (CB2) is a Stage 2, superiority, single-blind, randomized, parallel group, active-control, behavioral clinical trial delivered virtually within a telehealth service delivery model to individuals with PPA. Ninety carefully characterized participants with clinically confirmed PPA will be randomized to one of two speech-language intervention arms: (1) Communication Bridge™ a dyadic intervention based in communication participation therapy models that incorporates salient training stimuli or (2) the control intervention a non-dyadic intervention based in impairment therapy models addressing word retrieval and language production that incorporates fixed stimuli. The superiority of Communication Bridge™ over the Control arm will be evaluated using primary outcomes of communication confidence and participation. Other outcomes include accuracy for trained words and scripts. Participants complete two therapy blocks over a 12-month period. Outcomes will be measured at baseline, at each therapy block, and at 12 months post enrollment. Discussion: The CB2 trial will supply Level 2 evidence regarding the efficacy of the Communication Bridge™ intervention delivered in a telehealth service delivery model for individuals with mild to moderate PPA. An important by-product of the CB2 trial is that these data can be used to evaluate the efficacy of speech-language interventions delivered in both trial arms for persons with PPA. The impact of these data should not be overlooked as they will yield important insights examining why interventions work and for whom, which will advance effectiveness trials for speech-language interventions in PPA. Trial Registration: ClinicalTrials.govNCT03371706. Registered prospectively on December 13, 2017.
AB - Background: Primary progressive aphasia (PPA) is a clinical dementia syndrome. Impairments in language (speaking, reading, writing, and understanding) are the primary and persistent symptoms. These impairments progress insidiously and devastate communication confidence, participation, and quality of life for persons living with PPA. Currently, there are no effective disease modifying treatments for PPA. Speech-language interventions hold promise for mitigating communication challenges and language symptoms. However, evidence regarding their efficacy in PPA is of low quality and there are currently no rigorous randomized trials. Method: Communication Bridge™-2 (CB2) is a Stage 2, superiority, single-blind, randomized, parallel group, active-control, behavioral clinical trial delivered virtually within a telehealth service delivery model to individuals with PPA. Ninety carefully characterized participants with clinically confirmed PPA will be randomized to one of two speech-language intervention arms: (1) Communication Bridge™ a dyadic intervention based in communication participation therapy models that incorporates salient training stimuli or (2) the control intervention a non-dyadic intervention based in impairment therapy models addressing word retrieval and language production that incorporates fixed stimuli. The superiority of Communication Bridge™ over the Control arm will be evaluated using primary outcomes of communication confidence and participation. Other outcomes include accuracy for trained words and scripts. Participants complete two therapy blocks over a 12-month period. Outcomes will be measured at baseline, at each therapy block, and at 12 months post enrollment. Discussion: The CB2 trial will supply Level 2 evidence regarding the efficacy of the Communication Bridge™ intervention delivered in a telehealth service delivery model for individuals with mild to moderate PPA. An important by-product of the CB2 trial is that these data can be used to evaluate the efficacy of speech-language interventions delivered in both trial arms for persons with PPA. The impact of these data should not be overlooked as they will yield important insights examining why interventions work and for whom, which will advance effectiveness trials for speech-language interventions in PPA. Trial Registration: ClinicalTrials.govNCT03371706. Registered prospectively on December 13, 2017.
KW - Alzheimer’s
KW - Aphasia
KW - Behavioral intervention
KW - Communication
KW - Dementia
KW - Dyadic intervention
KW - Frontotemporal dementia
KW - Language
KW - Primary progressive aphasia
KW - Randomized clinical trial
KW - Speech
KW - Speech-language pathology
KW - Telehealth
KW - Therapy
UR - http://www.scopus.com/inward/record.url?scp=85131794393&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85131794393&partnerID=8YFLogxK
U2 - 10.1186/s13063-022-06162-7
DO - 10.1186/s13063-022-06162-7
M3 - Article
C2 - 35698099
AN - SCOPUS:85131794393
VL - 23
JO - Trials
JF - Trials
SN - 1745-6215
IS - 1
M1 - 487
ER -