NCT05926908

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
596

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
Last Updated

April 6, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

June 12, 2023

Last Update Submit

April 2, 2025

Conditions

In-hospital MobilityGeriatricImmobilization

Keywords

MobilisationRehabilitationolder adultsinactivityhospitalisation

Outcome Measures

Primary Outcomes (2)

  • Change in patients mobilised at lunch

    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

    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 Outcomes (7)

  • Change in chairs present bedside at breakfast

    Two, three, four, five, and six months

  • Change in chairs present bedside at lunch

    Two, three, four, five, and six months

  • Self-reported level of mobilisation

    One and six months

  • The Mobilisation Initiative

    One and six months

  • Formal Education

    Four and five months

  • +2 more secondary outcomes

Study Arms (2)

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 InitiativeBehavioral: Focus Group InterviewsBehavioral: Formal EducationBehavioral: Self-reported Level of MobilisationBehavioral: Observations of Patients and the EnvironmentBehavioral: Awareness of Mobilisation Survey

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 InitiativeBehavioral: Focus Group InterviewsBehavioral: Formal EducationBehavioral: Self-reported Level of MobilisationBehavioral: Observations of Patients and the EnvironmentBehavioral: Awareness of Mobilisation Survey

Interventions

A Mobilisation InitiativeBEHAVIORAL

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

Geriatric wardMedical ward
Focus Group InterviewsBEHAVIORAL

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

Geriatric wardMedical ward
Formal EducationBEHAVIORAL

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

Geriatric wardMedical ward
Self-reported Level of MobilisationBEHAVIORAL

Patient's self-reported mealtime mobilisation level reported through interview-based surveys, including structured follow-up questions

Geriatric wardMedical ward
Observations of Patients and the EnvironmentBEHAVIORAL

During breakfast and lunch, the mobilisation status of all patients in the wards is observed using an observation checklist

Geriatric wardMedical ward
Awareness of Mobilisation SurveyBEHAVIORAL

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

Geriatric wardMedical ward

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients in the geriatric and medical wards at Copenhagen University Hospital, Rigshospitalet

You may qualify if:

  • In-hospital patients in the geriatric and medical ward at Copenhagen University Hospital, Rigshospitalet

You may not qualify if:

  • Patients declared moribund or delirious in the electronical medical journal
  • Patients isolated in the hospital room
  • Patients requiring interpreter for communication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

Location

Related Publications (1)

  • Piper KS, Oxfeldt M, Pedersen MM, Christensen J. Hospital-induced immobility - a backstage story of lack of chairs, time, and assistance. BMC Geriatr. 2024 Aug 24;24(1):704. doi: 10.1186/s12877-024-05286-6.

    PMID: 39182057DERIVED

Related Links

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior researcher, Head of research

Study Record Dates

First Submitted

June 12, 2023

First Posted

July 3, 2023

Study Start

April 1, 2021

Primary Completion

October 1, 2021

Study Completion

December 31, 2021

Last Updated

April 6, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)