An INtervention TO Improve MOBility of Older Hospitalized Patients

Sarcopenia Clinical Trial

— INTOMOB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05639231
• Other study ID #: 2022-01568
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2022
• Est. completion date: April 30, 2025

Study information

• Verified date: March 2024
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: Carole E Aubert, MD, MSc
• Phone: +41 31 664 24 34
• Email: caroleelodie.aubert[@]insel.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 294
• Est. completion date: April 30, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Functional Status
• Iatrogenic Disease
• Mobility Limitation
• Muscle Atrophy or Weakness
• Muscular Atrophy
• Sarcopenia

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Kantonsspital Baden	Baden	Aargau
Switzerland	Inselspital, Bern University Hospital, InselGruppe AG	Bern
Switzerland	Spital Tiefenau, InselGruppe AG	Bern
Switzerland	HFR-Fribourg - hôpital cantonal	Villars-sur-Glâne	Fribourg

Sponsors (4)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern	Hôpital Fribourgeois, Kantonsspital Baden, Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Primary	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	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
Secondary	Activities of Daily Living	Measured by the Barthel Index by telephone interview of the participant/relatives	Day 30 (+/-5) after enrollment
Secondary	Activities of Daily Living	Measured by the Barthel Index by telephone interview of the participant/relatives	Day 180 (+/-5) after enrollment
Secondary	Instrumental Activities of Daily Living	Measured by the Lawton Index by telephone interview of the participant/relatives	Day 30 (+/-5) after enrollment
Secondary	Instrumental Activities of Daily Living	Measured by the Lawton Index by telephone interview of the participant/relatives	Day 180 (+/-5) after enrollment
Secondary	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
Secondary	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
Secondary	Depression	Measured by the Patient Health Questionnaire (PHQ)-2 by telephone interview of the participant/relatives	Day 30 (+/-5) after enrollment
Secondary	Depression	Measured by the Patient Health Questionnaire (PHQ)-2 by telephone interview of the participant/relatives	Day 180 (+/-5) after enrollment
Secondary	Pressure ulcer	Evaluated according to the NPUAP/EPUAP classification, based on nurse report and electronic health record	Discharge (-1 to +2 days after discharge)
Secondary	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)
Secondary	Mobility at discharge	Measured by the de Morton Mobility Index (DEMMI); assessment conducted by the study team	Discharge (maximum 1 day before)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Fear of / concerns about falling	Measured by the Falls Efficacy Scale - International by telephone interview of the participant/relatives	Day 30 (+/-5) after enrollment
Secondary	Fear of / concerns about falling	Measured by the Falls Efficacy Scale - International by telephone interview of the participant/relatives	Day 180 (+/-5) after enrollment
Secondary	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)
Secondary	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)]
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	Number of patients with new institutionalization within 30 days of discharge	Assessed by telephone interview of the participant/relatives	Day 30 (+/-5) after enrollment
Secondary	Number of patients with new institutionalization within 180 days of discharge	Assessed by telephone interview of the participant/relatives	Day 180 (+/-5) after enrollment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	Satisfaction with hospitalization	Measured by the satisfaction questionnaire adapted and simplified	Discharge (-1 to +2 days after discharge)
Secondary	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
Secondary	Location at follow-up	Assessed by telephone interview of patient/relatives.	Day 30 (+/-5) after enrollment
Secondary	Location at follow-up	Assessed by telephone interview of patient/relatives.	Day 180 (+/-5) after enrollment
Secondary	Discharge destination	Assessed based on electronic health records	Discharge (-1 to +2 days after discharge)