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Use of Home-Based Connected Devices in Patients With Cystic Fibrosis for the Early Detection and Treatment of Pulmonary Exacerbations: Protocol for a Qualitative Study

BACKGROUND: Early detection of pulmonary exacerbations (PEx) in patients with cystic fibrosis (CF) is important to quickly trigger treatment and reduce respiratory damage. We hypothesized that using home-based and wearable connected devices (CDs) and educating patients to react in case of abnormal v...

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Autores principales: Morsa, Maxime, Perrin, Amélie, David, Valérie, Rault, Gilles, Le Roux, Enora, Alberti, Corinne, Gagnayre, Rémi, Pougheon Bertrand, Dominique
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8411325/
https://www.ncbi.nlm.nih.gov/pubmed/34406124
http://dx.doi.org/10.2196/14552
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author Morsa, Maxime
Perrin, Amélie
David, Valérie
Rault, Gilles
Le Roux, Enora
Alberti, Corinne
Gagnayre, Rémi
Pougheon Bertrand, Dominique
author_facet Morsa, Maxime
Perrin, Amélie
David, Valérie
Rault, Gilles
Le Roux, Enora
Alberti, Corinne
Gagnayre, Rémi
Pougheon Bertrand, Dominique
author_sort Morsa, Maxime
collection PubMed
description BACKGROUND: Early detection of pulmonary exacerbations (PEx) in patients with cystic fibrosis (CF) is important to quickly trigger treatment and reduce respiratory damage. We hypothesized that using home-based and wearable connected devices (CDs) and educating patients to react in case of abnormal variations in a set of parameters would allow patients to detect and manage their PEx early with their care team. OBJECTIVE: This qualitative study aimed to assess the feasibility and appropriate conditions of a new PEx management process from the users’ point of view by analyzing the experience of patients and of CF center teams regarding the education program, the use of CDs, and the relationship between the patient and the care team during PEx management. METHODS: We have been conducting a multicenter pilot study involving 36 patients with CF aged ≥12 years. The intervention was divided into 3 phases. In phase 1 (3 months), patients were equipped with CDs, and their parameters were collected on 3 nonconsecutive days each week. Phase 2 involved the development of a “React to PEx” educational program aimed at providing patients with a personalized action plan. A training session to the educational program was organized for the physicians. Physicians then determined the patients’ personalized alert thresholds by reviewing the data collected during phase 1 and their patients’ clinical history. In phase 3 (12 months), patients were educated by the physician during a clinic visit, and their action plan for reacting in timely fashion to their PEx signs was defined. Education and action plans were revised during clinic visits. At the end of the project, the patients’ experience was collected during semistructured interviews with a researcher as part of the qualitative study. The experience of CF teams was collected during focus groups using a semistructured guide once all their patients had finished the study. The interviews and focus groups were recorded and transcribed verbatim to be analyzed. Data from educational sessions were collected throughout the educational program to be put into perspective with the learnings reported by patients. Analyses are being led by 2 researchers using NVivo (QSR International). RESULTS: The study received the favorable reception of the Committee for the Protection of Persons (CPP NORTH WEST III) on June 10, 2017 (#2017-A00723-50). Out of the 36 patients included in phase 1, 27 were educated and entered phase 3. We completed collection of all data from the patients and care providers. Qualitative analysis will provide a better understanding of users’ experience on the conditions of data collection, how useful CDs are for detecting PEx, how useful the PEx action plan is for reacting quickly, what patients learned about PEx management, and the conditions for this PEx management to be sustainable in routine care. CONCLUSIONS: This study will open new perspectives for further research into the implementation of an optimal PEx care process in the organization of care teams in order to support patient self-management. TRIAL REGISTRATION: ClinicalTrials.gov NCT03304028; https://clinicaltrials.gov/ct2/show/results/NCT03304028 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/14552
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spelling pubmed-84113252021-09-24 Use of Home-Based Connected Devices in Patients With Cystic Fibrosis for the Early Detection and Treatment of Pulmonary Exacerbations: Protocol for a Qualitative Study Morsa, Maxime Perrin, Amélie David, Valérie Rault, Gilles Le Roux, Enora Alberti, Corinne Gagnayre, Rémi Pougheon Bertrand, Dominique JMIR Res Protoc Protocol BACKGROUND: Early detection of pulmonary exacerbations (PEx) in patients with cystic fibrosis (CF) is important to quickly trigger treatment and reduce respiratory damage. We hypothesized that using home-based and wearable connected devices (CDs) and educating patients to react in case of abnormal variations in a set of parameters would allow patients to detect and manage their PEx early with their care team. OBJECTIVE: This qualitative study aimed to assess the feasibility and appropriate conditions of a new PEx management process from the users’ point of view by analyzing the experience of patients and of CF center teams regarding the education program, the use of CDs, and the relationship between the patient and the care team during PEx management. METHODS: We have been conducting a multicenter pilot study involving 36 patients with CF aged ≥12 years. The intervention was divided into 3 phases. In phase 1 (3 months), patients were equipped with CDs, and their parameters were collected on 3 nonconsecutive days each week. Phase 2 involved the development of a “React to PEx” educational program aimed at providing patients with a personalized action plan. A training session to the educational program was organized for the physicians. Physicians then determined the patients’ personalized alert thresholds by reviewing the data collected during phase 1 and their patients’ clinical history. In phase 3 (12 months), patients were educated by the physician during a clinic visit, and their action plan for reacting in timely fashion to their PEx signs was defined. Education and action plans were revised during clinic visits. At the end of the project, the patients’ experience was collected during semistructured interviews with a researcher as part of the qualitative study. The experience of CF teams was collected during focus groups using a semistructured guide once all their patients had finished the study. The interviews and focus groups were recorded and transcribed verbatim to be analyzed. Data from educational sessions were collected throughout the educational program to be put into perspective with the learnings reported by patients. Analyses are being led by 2 researchers using NVivo (QSR International). RESULTS: The study received the favorable reception of the Committee for the Protection of Persons (CPP NORTH WEST III) on June 10, 2017 (#2017-A00723-50). Out of the 36 patients included in phase 1, 27 were educated and entered phase 3. We completed collection of all data from the patients and care providers. Qualitative analysis will provide a better understanding of users’ experience on the conditions of data collection, how useful CDs are for detecting PEx, how useful the PEx action plan is for reacting quickly, what patients learned about PEx management, and the conditions for this PEx management to be sustainable in routine care. CONCLUSIONS: This study will open new perspectives for further research into the implementation of an optimal PEx care process in the organization of care teams in order to support patient self-management. TRIAL REGISTRATION: ClinicalTrials.gov NCT03304028; https://clinicaltrials.gov/ct2/show/results/NCT03304028 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/14552 JMIR Publications 2021-08-18 /pmc/articles/PMC8411325/ /pubmed/34406124 http://dx.doi.org/10.2196/14552 Text en ©Maxime Morsa, Amélie Perrin, Valérie David, Gilles Rault, Enora Le Roux, Corinne Alberti, Rémi Gagnayre, Dominique Pougheon Bertrand. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 18.08.2021. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.
spellingShingle Protocol
Morsa, Maxime
Perrin, Amélie
David, Valérie
Rault, Gilles
Le Roux, Enora
Alberti, Corinne
Gagnayre, Rémi
Pougheon Bertrand, Dominique
Use of Home-Based Connected Devices in Patients With Cystic Fibrosis for the Early Detection and Treatment of Pulmonary Exacerbations: Protocol for a Qualitative Study
title Use of Home-Based Connected Devices in Patients With Cystic Fibrosis for the Early Detection and Treatment of Pulmonary Exacerbations: Protocol for a Qualitative Study
title_full Use of Home-Based Connected Devices in Patients With Cystic Fibrosis for the Early Detection and Treatment of Pulmonary Exacerbations: Protocol for a Qualitative Study
title_fullStr Use of Home-Based Connected Devices in Patients With Cystic Fibrosis for the Early Detection and Treatment of Pulmonary Exacerbations: Protocol for a Qualitative Study
title_full_unstemmed Use of Home-Based Connected Devices in Patients With Cystic Fibrosis for the Early Detection and Treatment of Pulmonary Exacerbations: Protocol for a Qualitative Study
title_short Use of Home-Based Connected Devices in Patients With Cystic Fibrosis for the Early Detection and Treatment of Pulmonary Exacerbations: Protocol for a Qualitative Study
title_sort use of home-based connected devices in patients with cystic fibrosis for the early detection and treatment of pulmonary exacerbations: protocol for a qualitative study
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8411325/
https://www.ncbi.nlm.nih.gov/pubmed/34406124
http://dx.doi.org/10.2196/14552
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