Sequential exploratory mixed-method research of an eHealth intervention on blood pressure, sleep quality and physical activity in obstructive sleep apnoea: rationale and methodology of the Moore4Medical trial protocol
Introduction The management of a chronic and frequent pathology, such as obstructive sleep apnoea (OSA), requires personalised programmes that implement new technology-based tools to improve the comprehensive treatment of the patient to reduce the morbidity associated with this disease. This study w...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2024-12-01
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| Series: | BMJ Open Respiratory Research |
| Online Access: | https://bmjopenrespres.bmj.com/content/11/1/e001889.full |
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| author | Manuel Sánchez-de-la-Torre Ferran Barbé Oriol Martínez-Navarro Francisco José Verdejo-Amengual Fran Valenzuela-Pascual Joan Blanco-Blanco Rabie Adel El Arab Esther Rubinat-Arnaldo Maria Masbernat-Almenara Francesc Rubí‑Carnacea Blanca Manuel Martí |
| author_facet | Manuel Sánchez-de-la-Torre Ferran Barbé Oriol Martínez-Navarro Francisco José Verdejo-Amengual Fran Valenzuela-Pascual Joan Blanco-Blanco Rabie Adel El Arab Esther Rubinat-Arnaldo Maria Masbernat-Almenara Francesc Rubí‑Carnacea Blanca Manuel Martí |
| author_sort | Manuel Sánchez-de-la-Torre |
| collection | DOAJ |
| description | Introduction The management of a chronic and frequent pathology, such as obstructive sleep apnoea (OSA), requires personalised programmes that implement new technology-based tools to improve the comprehensive treatment of the patient to reduce the morbidity associated with this disease. This study will evaluate the effectiveness of an eHealth tool in managing the pathophysiological consequences of OSA and how they impact the quality of life after 3 months of intervention among adults.Methods and analysis This is a mixed-method sequential exploratory study protocol. Participants will be≥18 years with a new diagnosis of moderate OSA and diagnosed with hypertension. The qualitative phase will consist of personal semistructured interviews. The quantitative phase will be a triple-blind randomised controlled trial. The experimental group (n=135) will receive an eHealth intervention using an electronic wrist device and a mobile application that will offer specific healthcare recommendations, physical activity indications and hygienic and dietary advice. These recommendations will be based on the information obtained in the qualitative phase. Those in the control group (n=135) will receive the usual educational materials from the sleep unit. The primary outcome will be blood pressure changes at 3 months. Secondary outcomes are subjective sleep quality, sleep apnoea-related parameters, daytime sleepiness, physical activity, empowerment and motivation for change, quality of life, anthropometry, cost–benefit and adherence.Ethics and dissemination Ethical approval for the study has been obtained from the Hospital Universitari Arnau de Vilanova (CEIC-2511). Results will be published in a peer-reviewed journal.Trial registration number ClinicalTrials.gov Identifier: NCT05380726. |
| format | Article |
| id | doaj-art-0dc4f159deb54f478e4e46f11bb34fa2 |
| institution | Kabale University |
| issn | 2052-4439 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open Respiratory Research |
| spelling | doaj-art-0dc4f159deb54f478e4e46f11bb34fa22025-01-14T21:05:09ZengBMJ Publishing GroupBMJ Open Respiratory Research2052-44392024-12-0111110.1136/bmjresp-2023-001889Sequential exploratory mixed-method research of an eHealth intervention on blood pressure, sleep quality and physical activity in obstructive sleep apnoea: rationale and methodology of the Moore4Medical trial protocolManuel Sánchez-de-la-Torre0Ferran Barbé1Oriol Martínez-Navarro2Francisco José Verdejo-Amengual3Fran Valenzuela-Pascual4Joan Blanco-Blanco5Rabie Adel El Arab6Esther Rubinat-Arnaldo7Maria Masbernat-Almenara8Francesc Rubí‑Carnacea9Blanca Manuel Martí10Precision Medicine in Chronic Diseases, Hospital Universitari Arnau de Vilanova-Santa Maria, IRB Lleida, Lleida, SpainTranslation Research in Respiratory Medicine, Hospital Universitari Arnau de Vilanova-Santa María, IRB Lleida, Lleida, SpainDepartment of Nursing and Physiotherapy, University of Lleida, Lleida, SpainDepartment of Nursing and Physiotherapy, University of Lleida, Lleida, SpainDepartment of Nursing and Physiotherapy, University of Lleida, Lleida, SpainResearch Group of Healthcare (GRECS) , Institute for Biomedical Research Dr Pifarre Foundation, Lleida, SpainResearch Group of Healthcare (GRECS) , Institute for Biomedical Research Dr Pifarre Foundation, Lleida, SpainDepartment of Nursing and Physiotherapy, University of Lleida, Lleida, SpainDepartment of Nursing and Physiotherapy, University of Lleida, Lleida, SpainDepartment of Nursing and Physiotherapy, University of Lleida, Lleida, SpainDepartment of Nursing and Physiotherapy, University of Lleida, Lleida, SpainIntroduction The management of a chronic and frequent pathology, such as obstructive sleep apnoea (OSA), requires personalised programmes that implement new technology-based tools to improve the comprehensive treatment of the patient to reduce the morbidity associated with this disease. This study will evaluate the effectiveness of an eHealth tool in managing the pathophysiological consequences of OSA and how they impact the quality of life after 3 months of intervention among adults.Methods and analysis This is a mixed-method sequential exploratory study protocol. Participants will be≥18 years with a new diagnosis of moderate OSA and diagnosed with hypertension. The qualitative phase will consist of personal semistructured interviews. The quantitative phase will be a triple-blind randomised controlled trial. The experimental group (n=135) will receive an eHealth intervention using an electronic wrist device and a mobile application that will offer specific healthcare recommendations, physical activity indications and hygienic and dietary advice. These recommendations will be based on the information obtained in the qualitative phase. Those in the control group (n=135) will receive the usual educational materials from the sleep unit. The primary outcome will be blood pressure changes at 3 months. Secondary outcomes are subjective sleep quality, sleep apnoea-related parameters, daytime sleepiness, physical activity, empowerment and motivation for change, quality of life, anthropometry, cost–benefit and adherence.Ethics and dissemination Ethical approval for the study has been obtained from the Hospital Universitari Arnau de Vilanova (CEIC-2511). Results will be published in a peer-reviewed journal.Trial registration number ClinicalTrials.gov Identifier: NCT05380726.https://bmjopenrespres.bmj.com/content/11/1/e001889.full |
| spellingShingle | Manuel Sánchez-de-la-Torre Ferran Barbé Oriol Martínez-Navarro Francisco José Verdejo-Amengual Fran Valenzuela-Pascual Joan Blanco-Blanco Rabie Adel El Arab Esther Rubinat-Arnaldo Maria Masbernat-Almenara Francesc Rubí‑Carnacea Blanca Manuel Martí Sequential exploratory mixed-method research of an eHealth intervention on blood pressure, sleep quality and physical activity in obstructive sleep apnoea: rationale and methodology of the Moore4Medical trial protocol BMJ Open Respiratory Research |
| title | Sequential exploratory mixed-method research of an eHealth intervention on blood pressure, sleep quality and physical activity in obstructive sleep apnoea: rationale and methodology of the Moore4Medical trial protocol |
| title_full | Sequential exploratory mixed-method research of an eHealth intervention on blood pressure, sleep quality and physical activity in obstructive sleep apnoea: rationale and methodology of the Moore4Medical trial protocol |
| title_fullStr | Sequential exploratory mixed-method research of an eHealth intervention on blood pressure, sleep quality and physical activity in obstructive sleep apnoea: rationale and methodology of the Moore4Medical trial protocol |
| title_full_unstemmed | Sequential exploratory mixed-method research of an eHealth intervention on blood pressure, sleep quality and physical activity in obstructive sleep apnoea: rationale and methodology of the Moore4Medical trial protocol |
| title_short | Sequential exploratory mixed-method research of an eHealth intervention on blood pressure, sleep quality and physical activity in obstructive sleep apnoea: rationale and methodology of the Moore4Medical trial protocol |
| title_sort | sequential exploratory mixed method research of an ehealth intervention on blood pressure sleep quality and physical activity in obstructive sleep apnoea rationale and methodology of the moore4medical trial protocol |
| url | https://bmjopenrespres.bmj.com/content/11/1/e001889.full |
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