An INtervention TO Improve MOBility of Older Hospitalized Patients (INTOMOB)

Impact of an INtervention TO Increase MOBility in Older Hospitalized Medical Patients (INTOMOB): a Cluster Randomized Controlled Trial

Low mobility during an acute care hospitalization is very frequent, particularly among older patients, and associated with adverse outcomes, such as persistent functional decline, institutionalization and death. However, increasing hospital mobility remains challenging because of the multiple existing barriers.

The goal of this clinical trial is to test the effect of a multilevel intervention to increase hospital mobility, which addresses modifiable barriers and facilitators and does not require unavailable additional resources.

This study aims to answer whether this intervention can improve mobility and patient-relevant outcomes such as life-space mobility and functional status.

The multilevel intervention will target:

1. The patients, who will receive an information booklet, a customizable diary, an exercise booklet and an iPad with access to the videos of the exercise booklet.
2. The healthcare professionals (nursing staff and physicians) who will complete an e-learning, receive an oral presentation on the intervention, and receive a "mobility checklist" that reminds them of what they should assess daily regarding mobility.
3. The hospital environment, where posters will be hung in the wards, including walking itineraries, on topics of interest to older adults.

In a first phase, the intervention will be pilot-tested in one ward of each hospital. The intervention will then be adapted based on patient and healthcare professional feedback.

In a second phase, the intervention will be tested in a cluster randomized controlled trial, and compared to standard of care.

Study Overview

• Status: Recruiting
• Conditions: Iatrogenic Disease; Sarcopenia; Hospital Mobility; Mobility Limitation; Life-Space; Functional Status; Hospital-Acquired Condition; Muscle Atrophy or Weakness
• Intervention / Treatment: Behavioral: INTOMOB intervention

• Study Type: Interventional
• Enrollment (Estimated): 294
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carole E Aubert, MD, MSc; Phone Number: +41 31 664 24 34; Email: caroleelodie.aubert@insel.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • Inselspital, Bern University Hospital, InselGruppe AG
    • Contact: Carole E Aubert, MD, MSc; Phone Number: +41 31 664 24 34; Email: caroleelodie.aubert@insel.ch
    • Principal Investigator: Carole E Aubert, MD, MSc
  • Bern, Switzerland, 3004
    • Terminated
    • Spital Tiefenau, InselGruppe AG
  • Aargau
    • Baden, Aargau, Switzerland, 5404
      • Recruiting
      • Kantonsspital Baden
      • Contact: Maria M Wertli, MD, PhD; Phone Number: +41 56 486 25 02; Email: maria.wertli@ksb.ch
  • Fribourg
    • Villars-sur-Glâne, Fribourg, Switzerland, 1752
      • Recruiting
      • HFR-Fribourg - hôpital cantonal
      • Contact: Marco Mancinetti, MD; Phone Number: +41 26 306 23 60; Email: marco.mancinetti@h-fr.ch
      • Contact: Sandrine Foucras; Phone Number: +41 26 306 21 06; Email: sandrine.foucras@h-fr.ch
      • Principal Investigator: Marco Mancinetti, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• Admission to a general internal medicine (GIM) ward of a participating hospital
• Age ≥60 years
• Being ambulatory during the 2 weeks before admission (self-report)
• Living in the community (not in a nursing home or another institution) for at least the last 30 days prior to admission
• Ability to understand French or German
• Planned length of stay at least 3 days after enrollment
• For the pilot-study only: Possibility to start the study within 48 hours after admission to the GIM ward

Exclusion criteria:

• Medical contraindication to walk (e.g., wound not allowing loading weight)
• Wheelchair-bound
• End-of-life
• Severe psychiatric disorder (severe depression, schizophrenia, psychosis)
• Delirium (according to the Confusion Assessment Method [CAM])

Additional exclusion criterion for the pilot-study only:

- Dementia (defined as Mini-Cog <3)

Additional exclusion criteria for the RCT only:

• Cognitive impairment making impossible to use study material (=implement the intervention) and to understand and sign informed consent, based on clinical judgement, except if a proxy can be actively involved in the study and provides consent
• Severe visual impairment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INTOMOB intervention; The intervention will be multilevel, targeting the patients, healthcare professionals (HCPs) and environment, as described under "Intervention description".	Behavioral: INTOMOB intervention; The intervention will be multilevel, targeting the patients, healthcare professionals (HCPs) and environment: PATIENTS: Information booklet on the importance/benefits of mobility, consequences of low mobility, how to be more active (with concrete information).; Customizable diary to document mobility goals, results, difficulties and needs.; Exercise booklet with explanations & pictures of mobility exercises (supine, sitting, standing).; iPad 10.2'' with videos of the exercises. HCPs (physicians & nursing staff): E-learning on the consequences of low mobility, barriers/facilitators to hospital mobility; recommendations, documentation, communication & interdisciplinary collaboration regarding mobility; implementation.; Oral presentation on the intervention.; Checklist to remind HCPs to address mobility. ENVIRONMENT: Posters in the wards about mobility and other topics of interest to older adults.; Walking itineraries in the wards.
No Intervention: Control; Control procedure in the randomized trial: Patients will receive standard of care, including physiotherapy if prescribed by the hospital physician and usual mobility recommendations and support by the HCPs.; HCPs will neither complete the e-learning, nor receive the checklist and the oral presentation.; The environment will not be modified in regards to mobility. Already existing information on this topic (e.g., small posters hanging in patient rooms) will not be removed, since it corresponds to current standard of care in some hospitals. In the pilot study, there will be no control procedure, since the objective is to assess experience and feasibility of the intervention, not its effects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Life-space level	Measured by the University of Alabama at Birmingham Study of Aging Life-Space Assessment (range 0-120, with maximum being a higher score = better outcome). For patients institutionalized, assessment through the Life-Space Assessment in Institutionalized Settings. Both scales can be merged since the scoring is similar. Assessment by telephone interview of the participant/relatives.	Day 30 (+/-5) after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activities of Daily Living	Measured by the Barthel Index by telephone interview of the participant/relatives	Day 30 (+/-5) after enrollment
Activities of Daily Living	Measured by the Barthel Index by telephone interview of the participant/relatives	Day 180 (+/-5) after enrollment
Instrumental Activities of Daily Living	Measured by the Lawton Index by telephone interview of the participant/relatives	Day 30 (+/-5) after enrollment
Instrumental Activities of Daily Living	Measured by the Lawton Index by telephone interview of the participant/relatives	Day 180 (+/-5) after enrollment
Quality of life (EQ-5D)	Measured by the European Quality of Life-5 Dimensions (EQ-5D) questionnaire by telephone interview of the participant/relatives	Day 30 (+/-5) after enrollment
Quality of life (EQ-5D)	Measured by the European Quality of Life-5 Dimensions (EQ-5D) questionnaire by telephone interview of the participant/relatives	Day 180 (+/-5) after enrollment
Depression	Measured by the Patient Health Questionnaire (PHQ)-2 by telephone interview of the participant/relatives	Day 30 (+/-5) after enrollment
Depression	Measured by the Patient Health Questionnaire (PHQ)-2 by telephone interview of the participant/relatives	Day 180 (+/-5) after enrollment
Pressure ulcer	Evaluated according to the NPUAP/EPUAP classification, based on nurse report and electronic health record	Discharge (-1 to +2 days after discharge)
Delirium during hospitalization (hospitalization duration expected to be 3 to 20 days on average)	Measured by the Confusion Assessment Method	Discharge (-1 to +2 days after discharge)
Mobility at discharge	Measured by the de Morton Mobility Index (DEMMI); assessment conducted by the study team	Discharge (maximum 1 day before)
Lower-limb muscle strength	Measured by lower-limb manual testing according to the method by Hislop and Montgomery; assessment conducted by the study team	Discharge (maximum 1 day before)
Step count during hospitalization (hospitalization duration expected to be 3 to 20 days on average)	Measured by a StepWatch ankle accelerometer or a GENEActiv wrist accelerometer (the choice of the device will be defined after the pilot study during which both accelerometers will be tested)	Discharge (hospitalization duration expected to be 3 to 20 days on average)
Level of activity during hospitalization (hospitalization duration expected to be 3 to 20 days on average)	Measured by GENEActiv wrist accelerometer (only if this accelerometer is chosen after the pilot study)	Discharge (hospitalization duration expected to be 3 to 20 days on average)
Fear of / concerns about falling	Measured by the Falls Efficacy Scale - International by telephone interview of the participant/relatives	Day 30 (+/-5) after enrollment
Fear of / concerns about falling	Measured by the Falls Efficacy Scale - International by telephone interview of the participant/relatives	Day 180 (+/-5) after enrollment
Fall-risk increasing drugs	Including loop diuretic, beta blocker, cardiac glycoside (digitalis, digoxin), statin, antipsychotic (neuroleptic), tricyclic antidepressant, selective serotonin reuptake inhibitor, other antidepressant, benzodiazepine, opioid, antiepileptic. Assessed through the electronic health record	Discharge (discharge letter) (hospitalization duration expected to be 3 to 20 days on average)
Fall-risk increasing drugs	Including loop diuretic, beta blocker, cardiac glycoside (digitalis, digoxin), statin, antipsychotic (neuroleptic), tricyclic antidepressant, selective serotonin reuptake inhibitor, other antidepressant, benzodiazepine, opioid, antiepileptic. Assessed by telephone interview of the participant	Day 30 (+/-5) after enrollment
Fall-risk increasing drugs	Including loop diuretic, beta blocker, cardiac glycoside (digitalis, digoxin), statin, antipsychotic (neuroleptic), tricyclic antidepressant, selective serotonin reuptake inhibitor, other antidepressant, benzodiazepine, opioid, antiepileptic. Assessed by telephone interview of the participant	Day 180 (+/-5) after enrollment
Number of patients with fall(s) during hospitalization (hospitalization duration expected to be 3 to 20 days on average)	Based on nurse report and electronic health record data	Discharge (-1 to +2 days after discharge)
Number of falls per patient during hospitalization (hospitalization duration expected to be 3 to 20 days on average)	Based on nurse report and electronic health record data	Discharge (-1 to +2 days after discharge)
Number of patients with fall(s) within 30 days after discharge	Assessed by telephone interview of the participant/relatives, based on a diary the participants/relatives will be asked to complete.	Day 30 (+/-5) after enrollment
Number of falls per patient within 30 days after discharge	Assessed by telephone interview of the participant/relatives, based on a diary the participants/relatives will be asked to complete.	Day 30 (+/-5) after enrollment
Number of patients with fall(s) within 180 days after discharge	Assessed by telephone interview of the participant/relatives, based on a diary the participants/relatives will be asked to complete.	Day 180 (+/-5) after enrollment
Number of falls per patient within 180 days after discharge	Assessed by telephone interview of the participant/relatives, based on a diary the participants/relatives will be asked to complete.	Day 180 (+/-5) after enrollment
Number of patients with new institutionalization at discharge	According to nurses / electronic health record / self-report by participant/relatives	Discharge (-1 to +2 days after discharge)
Number of patients with new institutionalization within 30 days of discharge	Assessed by telephone interview of the participant/relatives	Day 30 (+/-5) after enrollment
Number of patients with new institutionalization within 180 days of discharge	Assessed by telephone interview of the participant/relatives	Day 180 (+/-5) after enrollment
Number of patients with emergency room visits within 30 days of discharge	Assessed based on electronic health record and by telephone interview of the participant/relatives, based on the diary the participant/relatives will be asked to complete.	Day 30 (+/-5) after enrollment
Number of emergency room visits per patient within 30 days of discharge	Assessed based on electronic health record and by telephone interview of the participant/relatives, based on the diary the participant/relatives will be asked to complete.	Day 30 (+/-5) after enrollment
Number of patients with emergency room visits within 180 days of discharge	Assessed based on electronic health record and by telephone interview of the participant/relatives, based on the diary the participant/relatives will be asked to complete.	Day 180 (+/-5) after enrollment
Number of emergency room visits per patient within 180 days of discharge	Assessed based on electronic health record and by telephone interview of the participant/relatives, based on the diary the participant/relatives will be asked to complete.	Day 180 (+/-5) after enrollment
Number of patients with readmission within 30 days of discharge	Assessed based on electronic health record and by telephone interview of the participant/relatives, based on the diary the participant/relatives will be asked to complete.	Day 30 (+/-5) after enrollment
Number of readmissions per patient within 30 days of discharge	Assessed based on electronic health record and by telephone interview of the participant/relatives, based on the diary the participant/relatives will be asked to complete.	Day 30 (+/-5) after enrollment
Number of patients with readmission within 180 days of discharge	Assessed based on electronic health record and by telephone interview of the participant/relatives, based on the diary the participant/relatives will be asked to complete.	Day 180 (+/-5) after enrollment
Number of readmissions per patient within 180 days of discharge	Assessed based on electronic health record and by telephone interview of the participant/relatives, based on the diary the participant/relatives will be asked to complete.	Day 180 (+/-5) after enrollment
Experience of the intervention	Assessed through qualitative and quantitative questions by interview of the participants/relatives (on the ward or by telephone). For the intervention group only. Will be done at the end of the assessment to preserve outcome assessor blinding.	Discharge (-1 to +2 days after discharge)
Satisfaction with hospitalization	Measured by the satisfaction questionnaire adapted and simplified	Discharge (-1 to +2 days after discharge)
Perspectives on hospital mobility	Quantitative questions (Likert-scale answers) based on the Health Action Process Approach (HAPA) model (simplification of a survey used in the preparation phase of this study to assess perspectives of patients and healthcare professionals on hospital mobility).	Day 30 (+/-5) after enrollment
Life-space level	Measured by the University of Alabama at Birmingham Study of Aging Life-Space Assessment (or Life-Space Assessment in Institutionalized Settings for institutionalized patients) by telephone interview of the participant/relatives	Day 180 (+/-5) after enrollment
Hand-grip muscle strength	Measured by JAMAR (for the pilot study) and SAEHAN (for the RCT) hand dynamometer; assessment conducted by the study team	Discharge (maximum 1 day before)
Fear of / concerns about falling	Measured by the Falls Efficacy Scale - International by telephone interview of the participant/relatives	Discharge (-1 to +2 days after discharge)
Fall-risk increasing drugs during hospitalization	Including loop diuretic, beta blocker, cardiac glycoside (digitalis, digoxin), statin, antipsychotic (neuroleptic), tricyclic antidepressant, selective serotonin reuptake inhibitor, other antidepressant, benzodiazepine, opioid, antiepileptic. Assessed through the electronic health record	Discharge (discharge letter) (hospitalization duration expected to be 3 to 20 days on average)]
Location at follow-up	Assessed by telephone interview of patient/relatives.	Day 30 (+/-5) after enrollment
Location at follow-up	Assessed by telephone interview of patient/relatives.	Day 180 (+/-5) after enrollment
Discharge destination	Assessed based on electronic health records	Discharge (-1 to +2 days after discharge)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare professional experience of the intervention and perspectives on hospital mobility	Semi-structured interview and survey (in the intervention group only)	After cluster closure (on average 1 to 10 months, maximum 15 months)
Patient opinion on comfort and practicability of the StepWatch and GENEActiv accelerometers	Outcome of the pilot study only. Assessment through semi-structured interview	Discharge (-1 to +2 days after discharge)
Patient opinion on comfort and practicability of the ActiGraph accelerometer	Outcome of the randomized trial only. Assessment through semi-structured interview	Discharge (-1 to +2 days after discharge)

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Collaborators: Swiss National Science Foundation; Hôpital Fribourgeois; Kantonsspital Baden
• Investigators: Principal Investigator: Carole E Aubert, MD, MSc, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: November 28, 2022
• First Posted (Actual): December 6, 2022

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; Hospital mobility; Life-Space; Functional status; Hospital-Acquired disability; Movement; Ambulation
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Disease Attributes; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Atrophy; Sarcopenia; Muscular Atrophy; Mobility Limitation; Iatrogenic Disease
• Other Study ID Numbers: 2022-01568

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study protocol, statistical analysis plan, informed consent form will be published. Other data will be made available upon reasonable request.
• IPD Sharing Time Frame: After study completion
• IPD Sharing Access Criteria: Upon reasonable request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

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