Effect of goal-directed mobilisation intervention compared with standard care on physical activity among medical inpatients: protocol for the GoMob-in randomised controlled trial.
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BORIS DOI
Date of Publication
May 12, 2022
Publication Type
Article
Division/Institute
Author
Subject(s)
Series
BMJ open
ISSN or ISBN (if monograph)
2044-6055
Publisher
BMJ Publishing Group
Language
English
Publisher DOI
PubMed ID
35551091
Uncontrolled Keywords
Description
INTRODUCTION
Despite the fact that immobilisation is a major contributor to morbidity and mortality, patients hospitalised in general internal medicine (GIM) wards spend up to 50% of time in bed. Previous studies in selected patient populations showed increased mobility after implementation of goal-directed mobilisation (GDM). Due to the study design used so far, the degree of evidence is generally low. The effect of GDM on clinical outcomes and economically relevant indicators in patients hospitalised in GIM wards is currently unknown. This study aims to evaluate a GDM intervention compared to standard care on physical activity (de Morton Mobility Index, DEMMI) in medical inpatients.
METHODS AND ANALYSIS
GoMob-in is a randomised, controlled, open-label study with blinded outcome assessment. We plan to enrol 160 inpatients with indication for physiotherapy on GIM wards of a tertiary hospital in Bern, Switzerland. Adult patients newly hospitalised on GIM wards will be included in the study. The primary outcome will be the change in the DEMMI score between baseline and 5 days. Secondary outcomes are change of DEMMI (inclusion to hospital discharge), mobilisation time (inclusion to day 5, inclusion to discharge), in-hospital delirium episodes, number of in-hospital falls, length of stay, number of falls within 3 months, number of re-hospitalisations and all-cause mortality within 3 months, change in independence during activities of daily living, concerns of falling, and quality of life within 3 months and destination after 3 months. Patients in the intervention group will be attributed a regularly updated individual mobility goal level made visible for all stakeholders and get a short educational intervention on GDM.
ETHICS AND DISSEMINATION
This study has been approved by the responsible Ethics Board (Ethikkommission Bern/2020-02305). Written informed consent will be obtained from participants before study inclusion. Results will be published in open access policy peer-reviewed journals.
TRIAL REGISTRATION NUMBER
NCT04760392.
Despite the fact that immobilisation is a major contributor to morbidity and mortality, patients hospitalised in general internal medicine (GIM) wards spend up to 50% of time in bed. Previous studies in selected patient populations showed increased mobility after implementation of goal-directed mobilisation (GDM). Due to the study design used so far, the degree of evidence is generally low. The effect of GDM on clinical outcomes and economically relevant indicators in patients hospitalised in GIM wards is currently unknown. This study aims to evaluate a GDM intervention compared to standard care on physical activity (de Morton Mobility Index, DEMMI) in medical inpatients.
METHODS AND ANALYSIS
GoMob-in is a randomised, controlled, open-label study with blinded outcome assessment. We plan to enrol 160 inpatients with indication for physiotherapy on GIM wards of a tertiary hospital in Bern, Switzerland. Adult patients newly hospitalised on GIM wards will be included in the study. The primary outcome will be the change in the DEMMI score between baseline and 5 days. Secondary outcomes are change of DEMMI (inclusion to hospital discharge), mobilisation time (inclusion to day 5, inclusion to discharge), in-hospital delirium episodes, number of in-hospital falls, length of stay, number of falls within 3 months, number of re-hospitalisations and all-cause mortality within 3 months, change in independence during activities of daily living, concerns of falling, and quality of life within 3 months and destination after 3 months. Patients in the intervention group will be attributed a regularly updated individual mobility goal level made visible for all stakeholders and get a short educational intervention on GDM.
ETHICS AND DISSEMINATION
This study has been approved by the responsible Ethics Board (Ethikkommission Bern/2020-02305). Written informed consent will be obtained from participants before study inclusion. Results will be published in open access policy peer-reviewed journals.
TRIAL REGISTRATION NUMBER
NCT04760392.
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File | File Type | Format | Size | License | Publisher/Copright statement | Content | |
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e058509.full.pdf | text | Adobe PDF | 481.91 KB | Attribution (CC BY 4.0) | published |