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Feasibility of remote neurocognitive assessment: pandemic adaptations for a clinical trial, the Cognition and Obstructive Sleep Apnea in Parkinson’s Disease, Effect of Positive Airway Pressure Therapy (COPE-PAP) study

BACKGROUND: The COVID-19 pandemic poses challenges for timely outcome assessment in randomized clinical trials (RCT). Our aim was to describe our remote neurocognitive testing (NCT) protocol administered by telephone in patients with Parkinson’s disease (PD) and obstructive sleep apnea (OSA). METHOD...

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Autores principales: Lajoie, Annie C., Crane, Joelle, Robinson, Ann R., Lafontaine, Anne-Louise, Benedetti, Andrea, Kimoff, R. John, Kaminska, Marta
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8665856/
https://www.ncbi.nlm.nih.gov/pubmed/34895299
http://dx.doi.org/10.1186/s13063-021-05879-1
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author Lajoie, Annie C.
Crane, Joelle
Robinson, Ann R.
Lafontaine, Anne-Louise
Benedetti, Andrea
Kimoff, R. John
Kaminska, Marta
author_facet Lajoie, Annie C.
Crane, Joelle
Robinson, Ann R.
Lafontaine, Anne-Louise
Benedetti, Andrea
Kimoff, R. John
Kaminska, Marta
author_sort Lajoie, Annie C.
collection PubMed
description BACKGROUND: The COVID-19 pandemic poses challenges for timely outcome assessment in randomized clinical trials (RCT). Our aim was to describe our remote neurocognitive testing (NCT) protocol administered by telephone in patients with Parkinson’s disease (PD) and obstructive sleep apnea (OSA). METHODS: We studied PD patients with OSA and Montreal Cognitive Assessment (MoCA) score ≤ 27 participating in a RCT assessing OSA treatment impact on cognition. Trial outcomes included change in MoCA and specific cognitive domains from baseline to 3 and 6 months. With COVID19 pandemic-related restrictions, 3-month visits were converted from in-person to telephone administration with materials mailed to participants for compatible tests and retrieved by courier the same day. In exploratory analyses, we compared baseline vs. 3-month results in the control arm, which were not expected to change significantly (test-re-test), using a paired t-test and assessed agreement with the intraclass correlation coefficient (ICC). RESULTS: Seven participants were approached and agreed to remote NCT at 3-month follow-up. Compared to the in-person NCT control arm group, they were younger (60.6 versus 70.6 years) and had a shorter disease course (3.9 versus 9.2 years). Remote NCT data were complete. The mean test-retest difference in MoCA was similar for in-person and remote NCT control-arm groups (between group difference − 0.69; 95%CI − 3.67, 2.29). Agreement was good for MOCA and varied for specific neurocognitive tests. CONCLUSION: Telephone administration of the MoCA and a modified neurocognitive battery is feasible in patients with PD and OSA. Further validation will require a larger sample size. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05879-1.
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spelling pubmed-86658562021-12-13 Feasibility of remote neurocognitive assessment: pandemic adaptations for a clinical trial, the Cognition and Obstructive Sleep Apnea in Parkinson’s Disease, Effect of Positive Airway Pressure Therapy (COPE-PAP) study Lajoie, Annie C. Crane, Joelle Robinson, Ann R. Lafontaine, Anne-Louise Benedetti, Andrea Kimoff, R. John Kaminska, Marta Trials Letter BACKGROUND: The COVID-19 pandemic poses challenges for timely outcome assessment in randomized clinical trials (RCT). Our aim was to describe our remote neurocognitive testing (NCT) protocol administered by telephone in patients with Parkinson’s disease (PD) and obstructive sleep apnea (OSA). METHODS: We studied PD patients with OSA and Montreal Cognitive Assessment (MoCA) score ≤ 27 participating in a RCT assessing OSA treatment impact on cognition. Trial outcomes included change in MoCA and specific cognitive domains from baseline to 3 and 6 months. With COVID19 pandemic-related restrictions, 3-month visits were converted from in-person to telephone administration with materials mailed to participants for compatible tests and retrieved by courier the same day. In exploratory analyses, we compared baseline vs. 3-month results in the control arm, which were not expected to change significantly (test-re-test), using a paired t-test and assessed agreement with the intraclass correlation coefficient (ICC). RESULTS: Seven participants were approached and agreed to remote NCT at 3-month follow-up. Compared to the in-person NCT control arm group, they were younger (60.6 versus 70.6 years) and had a shorter disease course (3.9 versus 9.2 years). Remote NCT data were complete. The mean test-retest difference in MoCA was similar for in-person and remote NCT control-arm groups (between group difference − 0.69; 95%CI − 3.67, 2.29). Agreement was good for MOCA and varied for specific neurocognitive tests. CONCLUSION: Telephone administration of the MoCA and a modified neurocognitive battery is feasible in patients with PD and OSA. Further validation will require a larger sample size. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05879-1. BioMed Central 2021-12-11 /pmc/articles/PMC8665856/ /pubmed/34895299 http://dx.doi.org/10.1186/s13063-021-05879-1 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Letter
Lajoie, Annie C.
Crane, Joelle
Robinson, Ann R.
Lafontaine, Anne-Louise
Benedetti, Andrea
Kimoff, R. John
Kaminska, Marta
Feasibility of remote neurocognitive assessment: pandemic adaptations for a clinical trial, the Cognition and Obstructive Sleep Apnea in Parkinson’s Disease, Effect of Positive Airway Pressure Therapy (COPE-PAP) study
title Feasibility of remote neurocognitive assessment: pandemic adaptations for a clinical trial, the Cognition and Obstructive Sleep Apnea in Parkinson’s Disease, Effect of Positive Airway Pressure Therapy (COPE-PAP) study
title_full Feasibility of remote neurocognitive assessment: pandemic adaptations for a clinical trial, the Cognition and Obstructive Sleep Apnea in Parkinson’s Disease, Effect of Positive Airway Pressure Therapy (COPE-PAP) study
title_fullStr Feasibility of remote neurocognitive assessment: pandemic adaptations for a clinical trial, the Cognition and Obstructive Sleep Apnea in Parkinson’s Disease, Effect of Positive Airway Pressure Therapy (COPE-PAP) study
title_full_unstemmed Feasibility of remote neurocognitive assessment: pandemic adaptations for a clinical trial, the Cognition and Obstructive Sleep Apnea in Parkinson’s Disease, Effect of Positive Airway Pressure Therapy (COPE-PAP) study
title_short Feasibility of remote neurocognitive assessment: pandemic adaptations for a clinical trial, the Cognition and Obstructive Sleep Apnea in Parkinson’s Disease, Effect of Positive Airway Pressure Therapy (COPE-PAP) study
title_sort feasibility of remote neurocognitive assessment: pandemic adaptations for a clinical trial, the cognition and obstructive sleep apnea in parkinson’s disease, effect of positive airway pressure therapy (cope-pap) study
topic Letter
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8665856/
https://www.ncbi.nlm.nih.gov/pubmed/34895299
http://dx.doi.org/10.1186/s13063-021-05879-1
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