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

Insel Gruppe AG, University Hospital Bern

Status: Completed

Conditions: Hospital-Acquired Condition; Muscle Atrophy or Weakness; Functional Status; Mobility Limitation; Sarcopenia; Iatrogenic Disease; Hospital Mobility; Life-Space

Treatments: Behavioral: INTOMOB intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05639231

2022-01568

Details and patient eligibility

About

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.

Enrollment: 383 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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383 participants in 2 patient groups

INTOMOB intervention

Experimental group

Description:

The intervention will be multilevel, targeting the patients, healthcare professionals (HCPs) and environment, as described under "Intervention description".

Treatment:

Behavioral: INTOMOB intervention

Control

No Intervention group

Description:

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.