Clinical trial NCT05639231: An INtervention TO Improve MOBility of Older Hospitalized Patients
Official title: Impact of an INtervention TO Increase MOBility in Older Hospitalized Medical Patients (INTOMOB): a Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hospital Mobility
Mobility Limitation
Life-Space
Functional Status
Hospital-Acquired Condition
Muscle Atrophy or Weakness
Sarcopenia
Iatrogenic Disease
Keywords: Hospital mobility
Life-Space
Functional status
Hospital-Acquired disability
Exercise
Movement
Ambulation
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
name: Hôpital Fribourgeois
name: Kantonsspital Baden
First posted: 2022-12-06
Enrollment: 294
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In a first phase, the intervention will be pilot-tested in one ward of each hospital (no comparison group).

In a second phase, it will be tested in a parallel design (cluster randomized controlled trial).
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Life-space level
timeFrame: Day 30 (+/-5) after enrollment
Secondary outcomes:
measure: Life-space level
timeFrame: Day 180 (+/-5) after enrollment
measure: Activities of Daily Living
timeFrame: Day 30 (+/-5) after enrollment
measure: Activities of Daily Living
timeFrame: Day 180 (+/-5) after enrollment
measure: Instrumental Activities of Daily Living
timeFrame: Day 30 (+/-5) after enrollment
measure: Instrumental Activities of Daily Living
timeFrame: Day 180 (+/-5) after enrollment
measure: Quality of life (EQ-5D)
timeFrame: Day 30 (+/-5) after enrollment
measure: Quality of life (EQ-5D)
timeFrame: Day 180 (+/-5) after enrollment
measure: Depression
timeFrame: Day 30 (+/-5) after enrollment
measure: Depression
timeFrame: Day 180 (+/-5) after enrollment
measure: Pressure ulcer
timeFrame: Discharge (-1 to +2 days after discharge)
measure: Delirium during hospitalization (hospitalization duration expected to be 3 to 20 days on average)
timeFrame: Discharge (-1 to +2 days after discharge)
measure: Mobility at discharge
timeFrame: Discharge (maximum 1 day before)
measure: Lower-limb muscle strength
timeFrame: Discharge (maximum 1 day before)
measure: Hand-grip muscle strength
timeFrame: Discharge (maximum 1 day before)
measure: Step count during hospitalization (hospitalization duration expected to be 3 to 20 days on average)
timeFrame: Discharge (hospitalization duration expected to be 3 to 20 days on average)
measure: Level of activity during hospitalization (hospitalization duration expected to be 3 to 20 days on average)
timeFrame: Discharge (hospitalization duration expected to be 3 to 20 days on average)
measure: Fear of / concerns about falling
timeFrame: Discharge (-1 to +2 days after discharge)
measure: Fear of / concerns about falling
timeFrame: Day 30 (+/-5) after enrollment
measure: Fear of / concerns about falling
timeFrame: Day 180 (+/-5) after enrollment
measure: Fall-risk increasing drugs
timeFrame: Discharge (discharge letter) (hospitalization duration expected to be 3 to 20 days on average)
measure: Fall-risk increasing drugs during hospitalization
timeFrame: Discharge (discharge letter) (hospitalization duration expected to be 3 to 20 days on average)]
measure: Fall-risk increasing drugs
timeFrame: Day 30 (+/-5) after enrollment
measure: Fall-risk increasing drugs
timeFrame: Day 180 (+/-5) after enrollment
measure: Number of patients with fall(s) during hospitalization (hospitalization duration expected to be 3 to 20 days on average)
timeFrame: Discharge (-1 to +2 days after discharge)
measure: Number of falls per patient during hospitalization (hospitalization duration expected to be 3 to 20 days on average)
timeFrame: Discharge (-1 to +2 days after discharge)
measure: Number of patients with fall(s) within 30 days after discharge
timeFrame: Day 30 (+/-5) after enrollment
measure: Number of falls per patient within 30 days after discharge
timeFrame: Day 30 (+/-5) after enrollment
measure: Number of patients with fall(s) within 180 days after discharge
timeFrame: Day 180 (+/-5) after enrollment
measure: Number of falls per patient within 180 days after discharge
timeFrame: Day 180 (+/-5) after enrollment
measure: Number of patients with new institutionalization at discharge
timeFrame: Discharge (-1 to +2 days after discharge)
measure: Number of patients with new institutionalization within 30 days of discharge
timeFrame: Day 30 (+/-5) after enrollment
measure: Number of patients with new institutionalization within 180 days of discharge
timeFrame: Day 180 (+/-5) after enrollment
measure: Number of patients with emergency room visits within 30 days of discharge
timeFrame: Day 30 (+/-5) after enrollment
measure: Number of emergency room visits per patient within 30 days of discharge
timeFrame: Day 30 (+/-5) after enrollment
measure: Number of patients with emergency room visits within 180 days of discharge
timeFrame: Day 180 (+/-5) after enrollment
measure: Number of emergency room visits per patient within 180 days of discharge
timeFrame: Day 180 (+/-5) after enrollment
measure: Number of patients with readmission within 30 days of discharge
timeFrame: Day 30 (+/-5) after enrollment
measure: Number of readmissions per patient within 30 days of discharge
timeFrame: Day 30 (+/-5) after enrollment
measure: Number of patients with readmission within 180 days of discharge
timeFrame: Day 180 (+/-5) after enrollment
measure: Number of readmissions per patient within 180 days of discharge
timeFrame: Day 180 (+/-5) after enrollment
measure: Experience of the intervention
timeFrame: Discharge (-1 to +2 days after discharge)
measure: Satisfaction with hospitalization
timeFrame: Discharge (-1 to +2 days after discharge)
measure: Perspectives on hospital mobility
timeFrame: Day 30 (+/-5) after enrollment
measure: Location at follow-up
timeFrame: Day 30 (+/-5) after enrollment
measure: Location at follow-up
timeFrame: Day 180 (+/-5) after enrollment
measure: Discharge destination
timeFrame: Discharge (-1 to +2 days after discharge)
Other outcomes:
measure: Healthcare professional experience of the intervention and perspectives on hospital mobility
timeFrame: After cluster closure (on average 1 to 10 months, maximum 15 months)
measure: Patient opinion on comfort and practicability of the StepWatch and GENEActiv accelerometers
timeFrame: Discharge (-1 to +2 days after discharge)
measure: Patient opinion on comfort and practicability of the ActiGraph accelerometer
timeFrame: Discharge (-1 to +2 days after discharge)
Locations:
city: Baden
country: Switzerland
facility: Kantonsspital Baden
state: Aargau
city: Villars-sur-Glâne
country: Switzerland
facility: HFR-Fribourg - hôpital cantonal
state: Fribourg
city: Bern
country: Switzerland
facility: Spital Tiefenau, InselGruppe AG
city: Bern
country: Switzerland
facility: Inselspital, Bern University Hospital, InselGruppe AG
Study officials:
affiliation: Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland
name: Carole E Aubert, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: