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

Primary Purpose

Hospital Mobility, Mobility Limitation, Life-Space

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
INTOMOB intervention
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hospital Mobility focused on measuring Hospital mobility, Life-Space, Functional status, Hospital-Acquired disability, Exercise, Movement, Ambulation

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kantonsspital Baden
  • HFR-Fribourg - hôpital cantonalRecruiting
  • Spital Tiefenau, InselGruppe AG
  • Inselspital, Bern University Hospital, InselGruppe AGRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

INTOMOB intervention

Control

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Activities of Daily Living
Measured by the Barthel Index by telephone interview of the participant/relatives
Activities of Daily Living
Measured by the Barthel Index by telephone interview of the participant/relatives
Instrumental Activities of Daily Living
Measured by the Lawton Index by telephone interview of the participant/relatives
Instrumental Activities of Daily Living
Measured by the Lawton Index by telephone interview of the participant/relatives
Quality of life (EQ-5D)
Measured by the European Quality of Life-5 Dimensions (EQ-5D) questionnaire by telephone interview of the participant/relatives
Quality of life (EQ-5D)
Measured by the European Quality of Life-5 Dimensions (EQ-5D) questionnaire by telephone interview of the participant/relatives
Depression
Measured by the Patient Health Questionnaire (PHQ)-2 by telephone interview of the participant/relatives
Depression
Measured by the Patient Health Questionnaire (PHQ)-2 by telephone interview of the participant/relatives
Pressure ulcer
Evaluated according to the NPUAP/EPUAP classification, based on nurse report and electronic health record
Delirium during hospitalization (hospitalization duration expected to be 3 to 20 days on average)
Measured by the Confusion Assessment Method
Mobility at discharge
Measured by the de Morton Mobility Index (DEMMI); assessment conducted by the study team
Lower-limb muscle strength
Measured by lower-limb manual testing according to the method by Hislop and Montgomery; assessment conducted by the study team
Hand-grip muscle strength
Measured by JAMAR (for the pilot study) and SAEHAN (for the RCT) hand dynamometer; assessment conducted by the study team
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)
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)
Fear of / concerns about falling
Measured by the Falls Efficacy Scale - International by telephone interview of the participant/relatives
Fear of / concerns about falling
Measured by the Falls Efficacy Scale - International by telephone interview of the participant/relatives
Fear of / concerns about falling
Measured by the Falls Efficacy Scale - International by telephone interview of the participant/relatives
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
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
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
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
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
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
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.
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.
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.
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.
Number of patients with new institutionalization at discharge
According to nurses / electronic health record / self-report by participant/relatives
Number of patients with new institutionalization within 30 days of discharge
Assessed by telephone interview of the participant/relatives
Number of patients with new institutionalization within 180 days of discharge
Assessed by telephone interview of the participant/relatives
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.
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.
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.
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.
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.
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.
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.
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.
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.
Satisfaction with hospitalization
Measured by the satisfaction questionnaire adapted and simplified
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).
Location at follow-up
Assessed by telephone interview of patient/relatives.
Location at follow-up
Assessed by telephone interview of patient/relatives.
Discharge destination
Assessed based on electronic health records

Full Information

First Posted
November 28, 2022
Last Updated
August 14, 2023
Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Swiss National Science Foundation, Hôpital Fribourgeois, Kantonsspital Baden
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1. Study Identification

Unique Protocol Identification Number
NCT05639231
Brief Title
An INtervention TO Improve MOBility of Older Hospitalized Patients
Acronym
INTOMOB
Official Title
Impact of an INtervention TO Increase MOBility in Older Hospitalized Medical Patients (INTOMOB): a Cluster Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Swiss National Science Foundation, Hôpital Fribourgeois, Kantonsspital Baden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
294 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
INTOMOB intervention
Arm Type
Experimental
Arm Description
The intervention will be multilevel, targeting the patients, healthcare professionals (HCPs) and environment, as described under "Intervention description".
Arm Title
Control
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
INTOMOB intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Life-space level
Description
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.
Time Frame
Day 30 (+/-5) after enrollment
Secondary Outcome Measure Information:
Title
Life-space level
Description
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
Time Frame
Day 180 (+/-5) after enrollment
Title
Activities of Daily Living
Description
Measured by the Barthel Index by telephone interview of the participant/relatives
Time Frame
Day 30 (+/-5) after enrollment
Title
Activities of Daily Living
Description
Measured by the Barthel Index by telephone interview of the participant/relatives
Time Frame
Day 180 (+/-5) after enrollment
Title
Instrumental Activities of Daily Living
Description
Measured by the Lawton Index by telephone interview of the participant/relatives
Time Frame
Day 30 (+/-5) after enrollment
Title
Instrumental Activities of Daily Living
Description
Measured by the Lawton Index by telephone interview of the participant/relatives
Time Frame
Day 180 (+/-5) after enrollment
Title
Quality of life (EQ-5D)
Description
Measured by the European Quality of Life-5 Dimensions (EQ-5D) questionnaire by telephone interview of the participant/relatives
Time Frame
Day 30 (+/-5) after enrollment
Title
Quality of life (EQ-5D)
Description
Measured by the European Quality of Life-5 Dimensions (EQ-5D) questionnaire by telephone interview of the participant/relatives
Time Frame
Day 180 (+/-5) after enrollment
Title
Depression
Description
Measured by the Patient Health Questionnaire (PHQ)-2 by telephone interview of the participant/relatives
Time Frame
Day 30 (+/-5) after enrollment
Title
Depression
Description
Measured by the Patient Health Questionnaire (PHQ)-2 by telephone interview of the participant/relatives
Time Frame
Day 180 (+/-5) after enrollment
Title
Pressure ulcer
Description
Evaluated according to the NPUAP/EPUAP classification, based on nurse report and electronic health record
Time Frame
Discharge (-1 to +2 days after discharge)
Title
Delirium during hospitalization (hospitalization duration expected to be 3 to 20 days on average)
Description
Measured by the Confusion Assessment Method
Time Frame
Discharge (-1 to +2 days after discharge)
Title
Mobility at discharge
Description
Measured by the de Morton Mobility Index (DEMMI); assessment conducted by the study team
Time Frame
Discharge (maximum 1 day before)
Title
Lower-limb muscle strength
Description
Measured by lower-limb manual testing according to the method by Hislop and Montgomery; assessment conducted by the study team
Time Frame
Discharge (maximum 1 day before)
Title
Hand-grip muscle strength
Description
Measured by JAMAR (for the pilot study) and SAEHAN (for the RCT) hand dynamometer; assessment conducted by the study team
Time Frame
Discharge (maximum 1 day before)
Title
Step count during hospitalization (hospitalization duration expected to be 3 to 20 days on average)
Description
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)
Time Frame
Discharge (hospitalization duration expected to be 3 to 20 days on average)
Title
Level of activity during hospitalization (hospitalization duration expected to be 3 to 20 days on average)
Description
Measured by GENEActiv wrist accelerometer (only if this accelerometer is chosen after the pilot study)
Time Frame
Discharge (hospitalization duration expected to be 3 to 20 days on average)
Title
Fear of / concerns about falling
Description
Measured by the Falls Efficacy Scale - International by telephone interview of the participant/relatives
Time Frame
Discharge (-1 to +2 days after discharge)
Title
Fear of / concerns about falling
Description
Measured by the Falls Efficacy Scale - International by telephone interview of the participant/relatives
Time Frame
Day 30 (+/-5) after enrollment
Title
Fear of / concerns about falling
Description
Measured by the Falls Efficacy Scale - International by telephone interview of the participant/relatives
Time Frame
Day 180 (+/-5) after enrollment
Title
Fall-risk increasing drugs
Description
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
Time Frame
Discharge (discharge letter) (hospitalization duration expected to be 3 to 20 days on average)
Title
Fall-risk increasing drugs during hospitalization
Description
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
Time Frame
Discharge (discharge letter) (hospitalization duration expected to be 3 to 20 days on average)]
Title
Fall-risk increasing drugs
Description
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
Time Frame
Day 30 (+/-5) after enrollment
Title
Fall-risk increasing drugs
Description
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
Time Frame
Day 180 (+/-5) after enrollment
Title
Number of patients with fall(s) during hospitalization (hospitalization duration expected to be 3 to 20 days on average)
Description
Based on nurse report and electronic health record data
Time Frame
Discharge (-1 to +2 days after discharge)
Title
Number of falls per patient during hospitalization (hospitalization duration expected to be 3 to 20 days on average)
Description
Based on nurse report and electronic health record data
Time Frame
Discharge (-1 to +2 days after discharge)
Title
Number of patients with fall(s) within 30 days after discharge
Description
Assessed by telephone interview of the participant/relatives, based on a diary the participants/relatives will be asked to complete.
Time Frame
Day 30 (+/-5) after enrollment
Title
Number of falls per patient within 30 days after discharge
Description
Assessed by telephone interview of the participant/relatives, based on a diary the participants/relatives will be asked to complete.
Time Frame
Day 30 (+/-5) after enrollment
Title
Number of patients with fall(s) within 180 days after discharge
Description
Assessed by telephone interview of the participant/relatives, based on a diary the participants/relatives will be asked to complete.
Time Frame
Day 180 (+/-5) after enrollment
Title
Number of falls per patient within 180 days after discharge
Description
Assessed by telephone interview of the participant/relatives, based on a diary the participants/relatives will be asked to complete.
Time Frame
Day 180 (+/-5) after enrollment
Title
Number of patients with new institutionalization at discharge
Description
According to nurses / electronic health record / self-report by participant/relatives
Time Frame
Discharge (-1 to +2 days after discharge)
Title
Number of patients with new institutionalization within 30 days of discharge
Description
Assessed by telephone interview of the participant/relatives
Time Frame
Day 30 (+/-5) after enrollment
Title
Number of patients with new institutionalization within 180 days of discharge
Description
Assessed by telephone interview of the participant/relatives
Time Frame
Day 180 (+/-5) after enrollment
Title
Number of patients with emergency room visits within 30 days of discharge
Description
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.
Time Frame
Day 30 (+/-5) after enrollment
Title
Number of emergency room visits per patient within 30 days of discharge
Description
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.
Time Frame
Day 30 (+/-5) after enrollment
Title
Number of patients with emergency room visits within 180 days of discharge
Description
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.
Time Frame
Day 180 (+/-5) after enrollment
Title
Number of emergency room visits per patient within 180 days of discharge
Description
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.
Time Frame
Day 180 (+/-5) after enrollment
Title
Number of patients with readmission within 30 days of discharge
Description
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.
Time Frame
Day 30 (+/-5) after enrollment
Title
Number of readmissions per patient within 30 days of discharge
Description
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.
Time Frame
Day 30 (+/-5) after enrollment
Title
Number of patients with readmission within 180 days of discharge
Description
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.
Time Frame
Day 180 (+/-5) after enrollment
Title
Number of readmissions per patient within 180 days of discharge
Description
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.
Time Frame
Day 180 (+/-5) after enrollment
Title
Experience of the intervention
Description
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.
Time Frame
Discharge (-1 to +2 days after discharge)
Title
Satisfaction with hospitalization
Description
Measured by the satisfaction questionnaire adapted and simplified
Time Frame
Discharge (-1 to +2 days after discharge)
Title
Perspectives on hospital mobility
Description
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).
Time Frame
Day 30 (+/-5) after enrollment
Title
Location at follow-up
Description
Assessed by telephone interview of patient/relatives.
Time Frame
Day 30 (+/-5) after enrollment
Title
Location at follow-up
Description
Assessed by telephone interview of patient/relatives.
Time Frame
Day 180 (+/-5) after enrollment
Title
Discharge destination
Description
Assessed based on electronic health records
Time Frame
Discharge (-1 to +2 days after discharge)
Other Pre-specified Outcome Measures:
Title
Healthcare professional experience of the intervention and perspectives on hospital mobility
Description
Semi-structured interview and survey (in the intervention group only)
Time Frame
After cluster closure (on average 1 to 10 months, maximum 15 months)
Title
Patient opinion on comfort and practicability of the StepWatch and GENEActiv accelerometers
Description
Outcome of the pilot study only. Assessment through semi-structured interview
Time Frame
Discharge (-1 to +2 days after discharge)
Title
Patient opinion on comfort and practicability of the ActiGraph accelerometer
Description
Outcome of the randomized trial only. Assessment through semi-structured interview
Time Frame
Discharge (-1 to +2 days after discharge)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carole E Aubert, MD, MSc
Phone
+41 31 664 24 34
Email
caroleelodie.aubert@insel.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carole E Aubert, MD, MSc
Organizational Affiliation
Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kantonsspital Baden
City
Baden
State/Province
Aargau
ZIP/Postal Code
5404
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria M Wertli, MD, PhD
Phone
+41 56 486 25 02
Email
maria.wertli@ksb.ch
Facility Name
HFR-Fribourg - hôpital cantonal
City
Villars-sur-Glâne
State/Province
Fribourg
ZIP/Postal Code
1752
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Mancinetti, MD
Phone
+41 26 306 23 60
Email
marco.mancinetti@h-fr.ch
First Name & Middle Initial & Last Name & Degree
Sandrine Foucras
Phone
+41 26 306 21 06
Email
sandrine.foucras@h-fr.ch
First Name & Middle Initial & Last Name & Degree
Marco Mancinetti, MD
Facility Name
Spital Tiefenau, InselGruppe AG
City
Bern
ZIP/Postal Code
3004
Country
Switzerland
Individual Site Status
Terminated
Facility Name
Inselspital, Bern University Hospital, InselGruppe AG
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carole E Aubert, MD, MSc
Phone
+41 31 664 24 34
Email
caroleelodie.aubert@insel.ch
First Name & Middle Initial & Last Name & Degree
Carole E Aubert, MD, MSc

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study protocol, statistical analysis plan, informed consent form will be published. Other data will be made available upon reasonable request.
IPD Sharing Time Frame
After study completion
IPD Sharing Access Criteria
Upon reasonable request

Learn more about this trial

An INtervention TO Improve MOBility of Older Hospitalized Patients

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