An INtervention TO Improve MOBility of Older Hospitalized Patients

Study Overview
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Brief Summary
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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: 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. 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. 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.

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

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

Intervention / Treatment
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* Behavioral: INTOMOB intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INTOMOB intervention<br>The intervention will be multilevel, targeting the patients, healthcare professionals (HCPs) and environment, as described under Intervention description. | Behavioral: INTOMOB intervention<br>* 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.<br>|
| No Intervention: Control<br>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?
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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 |
| --- | --- | --- |
| 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 | 
| 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) | 
| 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) | 
| 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 | Discharge (-1 to +2 days after discharge) | 
| 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 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)] | 
| 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 | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hospital mobility, Life-Space, Functional status, Hospital-Acquired disability, Exercise, Movement, Ambulation