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| Name | Class |
|---|---|
| Swiss National Science Foundation | OTHER |
| Hôpital Fribourgeois | OTHER |
| Kantonsspital Baden | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INTOMOB intervention | Experimental | The intervention will be multilevel, targeting the patients, healthcare professionals (HCPs) and environment, as described under "Intervention description". |
|
| Control | No Intervention | Control procedure in the randomized trial:
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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INTOMOB intervention | Behavioral | The intervention will be multilevel, targeting the patients, healthcare professionals (HCPs) and environment: PATIENTS:
HCPs (physicians & nursing staff):
ENVIRONMENT:
|
| 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 |
| 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 |
| 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 |
Inclusion criteria:
Exclusion criteria:
Additional exclusion criterion for the pilot-study only:
- Dementia (defined as Mini-Cog <3)
Additional exclusion criteria for the RCT only:
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| Name | Affiliation | Role |
|---|---|---|
| Carole E Aubert, MD, MSc | Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital Baden | Baden | Canton of Aargau | 5404 | Switzerland | ||
| HFR-Fribourg - hôpital cantonal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37907858 | Derived | Mooser B, Bergsma D, Liechti FD, Baumgartner C, Gentizon J, Mean M, Wertli MM, Mancinetti M, Schmidt-Leuenberger J, Aubert CE. Impact of an INtervention to increase MOBility in older hospitalized medical patients (INTOMOB): Study protocol for a cluster randomized controlled trial. BMC Geriatr. 2023 Oct 31;23(1):705. doi: 10.1186/s12877-023-04285-3. |
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Study protocol, statistical analysis plan, informed consent form will be published. Other data will be made available upon reasonable request.
After study completion
Upon reasonable request
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 8, 2026 | |
| Reset | Jul 2, 2026 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 26, 2024 | Mar 26, 2024 |
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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).
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Complete blinding is difficult due to the nature of the intervention and the design (cluster randomization).
To preserve blinding as much as possible, several strategies have been set.
At the cluster level (healthcare professional intervention): Since rotation across wards happens at the physician level, but is rare at the level of the nursing staff, the healthcare professional intervention targets mostly nurses. The healthcare professionals will be informed to avoid speaking about the intervention with colleagues of other wards.
At the patient level, differential information for candidates for the intervention or for the control group (the randomization group is known when first approaching candidates for participation because of the cluster design) will be provided. Candidates for the control group will receive only partial information without explaining the intervention. They will be informed orally at the end of the study about all aspects of the study.
|
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) |
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) |
| Villars-sur-Glâne |
| Canton of Fribourg |
| 1752 |
| Switzerland |
| Spital Tiefenau, InselGruppe AG | Bern | 3004 | Switzerland |
| Inselspital, Bern University Hospital, InselGruppe AG | Bern | 3010 | Switzerland |
| SAP_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 8, 2026 | Jul 2, 2026 |
| ID | Term |
|---|---|
| D051346 | Mobility Limitation |
| D007049 | Iatrogenic Disease |
| D009133 | Muscular Atrophy |
| D001247 | Asthenia |
| D055948 | Sarcopenia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D001519 | Behavior |
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