- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05926908
Hospital-Induced Immobility
April 2, 2025 updated by: Jan Christensen, Rigshospitalet, Denmark
Hospital-Induced Immobility - A Backstage Story of Lack of Chairs, Time, and Assistance
Inactivity and bedrest during hospitalisation have numerous negative consequences, and it is especially important that older patients are mobile during hospitalisation.
In this study the investigators aimed to identify whether the introduction of formal education of clinical staff and a Mobilisation Initiative could increase mobilisation of patients in a geriatric and a medical ward.
Furthermore, the investigators wanted to explore patients' and health care staffs' view on facilitators and barriers for mobilisation during hospitalisation
Study Overview
Status
Completed
Conditions
Detailed Description
Staying in bed and being inactive during hospitalisation can lead to a range of adverse consequences especially among older adults.
The consequences include loss of muscle mass and strength leading to problems with loss of functional independence, risk of re-hospitalisation, and death.
Moreover, older adults do not recover as well as younger adults with poor long-term recovery.
The lack of in-hospital mobilisation is due to several factors including the hospital culture and organisational factors.
Therefore, it is necessary to bring attention to this problem among the hospital staff.
The aim of this study is to identify whether the introduction of formal education of clinical staff and a Mobilisation Initiative can increase the number of patients mobilised for breakfast and lunch among patients admitted to geriatric and medical wards.
The activities planned in this study is self-reported level of mealtime mobilisation and observations of the patients, focus group interviews and survey on mobilisation awareness among the clinical staff, introduction of formal education and a Mobilisation Initiative.
As hypothesized, this will result in an increased awareness of in-hospital mobilisation leading to an increase in the number of patients mobilised at mealtimes.
Accordingly, expectations are that this will affect the activity level of the hospitalised patients and reduce adverse consequences leading to an increase in functional independence and reduce the number of readmissions resulting in a socioeconomic benefit.
Study Type
Observational
Enrollment (Actual)
596
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Copenhagen, Denmark
- Rigshospitalet
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients in the geriatric and medical wards at Copenhagen University Hospital, Rigshospitalet
Description
Inclusion Criteria:
- In-hospital patients in the geriatric and medical ward at Copenhagen University Hospital, Rigshospitalet
Exclusion Criteria:
- Patients declared moribund or delirious in the electronical medical journal
- Patients isolated in the hospital room
- Patients requiring interpreter for communication
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Geriatric ward
Interventions are: Patients' self-reported level of mealtime mobilisation, observations of the patients' mobilisation level and environment at mealtimes, focus group interviews with health care professionals at the wards, survey on mobilisation awareness among the nursing staff, a Mobilisation Initiative, and formal education for all nursing staff
|
The Mobilisation Initiative consists of physiotherapists assisting nursing staff in mobilising patients to sit in a chair for breakfast and lunch.
This intervention follows the interventions of focus group interviews, formal education, observations of patients and the environment, and awareness of mobilisation survey
Focus group interviews using a semi-structured interview guide are conducted with health care professionals at the wards to explore the acceptability and demand for the contents of the Mobilisation Initiative, including the identification of facilitators and barriers to mobilisation
Formal education for all nursing staff employed at the two wards includes information on the consequences of immobilisation, with the purpose of enhancing confidence, competencies, and awareness of mobilisation
Patient's self-reported mealtime mobilisation level reported through interview-based surveys, including structured follow-up questions
During breakfast and lunch, the mobilisation status of all patients in the wards is observed using an observation checklist
To assess the nursing staff's awareness of and confidence in the mobilisation of the patients, a short survey on mobilisation awareness is distributed to the nursing staff at both wards
|
|
Medical ward
Interventions are: Patients' self-reported level of mealtime mobilisation, observations of the patients' mobilisation level and environment at mealtimes, focus group interviews with health care professionals at the wards, survey on mobilisation awareness among the nursing staff, a Mobilisation Initiative, and formal education for all nursing staff
|
The Mobilisation Initiative consists of physiotherapists assisting nursing staff in mobilising patients to sit in a chair for breakfast and lunch.
This intervention follows the interventions of focus group interviews, formal education, observations of patients and the environment, and awareness of mobilisation survey
Focus group interviews using a semi-structured interview guide are conducted with health care professionals at the wards to explore the acceptability and demand for the contents of the Mobilisation Initiative, including the identification of facilitators and barriers to mobilisation
Formal education for all nursing staff employed at the two wards includes information on the consequences of immobilisation, with the purpose of enhancing confidence, competencies, and awareness of mobilisation
Patient's self-reported mealtime mobilisation level reported through interview-based surveys, including structured follow-up questions
During breakfast and lunch, the mobilisation status of all patients in the wards is observed using an observation checklist
To assess the nursing staff's awareness of and confidence in the mobilisation of the patients, a short survey on mobilisation awareness is distributed to the nursing staff at both wards
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in patients mobilised at lunch
Time Frame: One, two, three, four, five, and six months
|
Change in percentage of patients mobilised at lunch t0-t1 Change in percentage of patients mobilised at lunch t1-t2 Change in percentage of patients mobilised at lunch t2-t3 Change in percentage of patients mobilised at lunch t3-t4 Change in percentage of patients mobilised at lunch t4-t5 Change in percentage of patients mobilised at lunch t5-t6
|
One, two, three, four, five, and six months
|
|
Change in patients mobilised at breakfast
Time Frame: One, two, three, four, five, and six months
|
Change in percentage of patients mobilised at breakfast t0-t1 Change in percentage of patients mobilised at breakfast t1-t2 Change in percentage of patients mobilised at breakfast t2-t3 Change in percentage of patients mobilised at breakfast t3-t4 Change in percentage of patients mobilised at breakfast t4-t5 Change in percentage of patients mobilised at breakfast t5-t6
|
One, two, three, four, five, and six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in chairs present bedside at breakfast
Time Frame: Two, three, four, five, and six months
|
Change in percentage of chairs observed placed bedside at breakfast for each patient t1-t2 Change in percentage of chairs observed placed bedside at breakfast for each patient t2-t3 Change in percentage of chairs observed placed bedside at breakfast for each patient t3-t4 Change in percentage of chairs observed placed bedside at breakfast for each patient t4-t5 Change in percentage of chairs observed placed bedside at breakfast for each patient t5-t6
|
Two, three, four, five, and six months
|
|
Change in chairs present bedside at lunch
Time Frame: Two, three, four, five, and six months
|
Change in percentage of chairs observed placed bedside at lunch for each patient t1-t2 Change in percentage of chairs observed placed bedside at lunch for each patient t2-t3 Change in percentage of chairs observed placed bedside at lunch for each patient t3-t4 Change in percentage of chairs observed placed bedside at lunch for each patient t4-t5 Change in percentage of chairs observed placed bedside at lunch for each patient t5-t6
|
Two, three, four, five, and six months
|
|
Self-reported level of mobilisation
Time Frame: One and six months
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Level of patient's mealtime mobilisation level reported through interview-based surveys on a 5-item ordinal scale: independently, with supervision, with the physical help of one person, with the physical help of two persons, or never sit in a chair.
|
One and six months
|
|
The Mobilisation Initiative
Time Frame: One and six months
|
The utilisation of the Mobilisation Initiative recorded as the daily number of patients referred to and mobilised in the Mobilisation Initiative at each ward
|
One and six months
|
|
Formal Education
Time Frame: Four and five months
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The number of nursing staff attending formal education
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Four and five months
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Focus Group Interviews
Time Frame: Two months
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Description of facilitators and barriers for mobilising the patients at each ward
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Two months
|
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Awareness of mobilisation among the nursing staff
Time Frame: Two months and follow up at eight months
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Levels of awareness on mobilisation among the nursing staff at each ward reported through questionnaires including the questions: "Do you feel confident mobilising your patients to sit in a chair at mealtimes?," "To what degree do you feel prepared to do a safe transfer from the bed to a chair with a patient you do not know?," and "How often do you talk to your colleagues about mobilisation?".
Questions are answered on 5-item Likert scales: never, less than half of the time, half of the time, more than half of the time, and every time; and to a very low degree, to a low degree, neither/nor, to a high degree, and to a very high degree
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Two months and follow up at eight months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2021
Primary Completion (Actual)
October 1, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
June 12, 2023
First Submitted That Met QC Criteria
June 21, 2023
First Posted (Actual)
July 3, 2023
Study Record Updates
Last Update Posted (Actual)
April 6, 2025
Last Update Submitted That Met QC Criteria
April 2, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- P-2020-1173
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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