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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Denmark
      • Copenhagen, Denmark
        • Rigshospitalet

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Behavioral: A Mobilisation Initiative
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
Behavioral: Focus Group Interviews
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
Behavioral: Formal Education
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
Behavioral: Self-reported Level of Mobilisation
Patient's self-reported mealtime mobilisation level reported through interview-based surveys, including structured follow-up questions
Behavioral: Observations of Patients and the Environment
During breakfast and lunch, the mobilisation status of all patients in the wards is observed using an observation checklist
Behavioral: Awareness of Mobilisation Survey
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
Behavioral: A Mobilisation Initiative
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
Behavioral: Focus Group Interviews
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
Behavioral: Formal Education
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
Behavioral: Self-reported Level of Mobilisation
Patient's self-reported mealtime mobilisation level reported through interview-based surveys, including structured follow-up questions
Behavioral: Observations of Patients and the Environment
During breakfast and lunch, the mobilisation status of all patients in the wards is observed using an observation checklist
Behavioral: Awareness of Mobilisation Survey
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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
The number of nursing staff attending formal education
Four and five months
Focus Group Interviews
Time Frame: Two months
Description of facilitators and barriers for mobilising the patients at each ward
Two months
Awareness of mobilisation among the nursing staff
Time Frame: Two months and follow up at eight months
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
Two months and follow up at eight months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rigshospitalet, Denmark

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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