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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05639231
Other study ID # 2022-01568
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 15, 2022
Est. completion date April 30, 2025

Study information

Verified date March 2024
Source Insel Gruppe AG, University Hospital Bern
Contact Carole E Aubert, MD, MSc
Phone +41 31 664 24 34
Email caroleelodie.aubert@insel.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 294
Est. completion date April 30, 2025
Est. primary completion date November 30, 2024
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
INTOMOB intervention
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.

Locations

Country Name City State
Switzerland Kantonsspital Baden Baden Aargau
Switzerland Inselspital, Bern University Hospital, InselGruppe AG Bern
Switzerland Spital Tiefenau, InselGruppe AG Bern
Switzerland HFR-Fribourg - hôpital cantonal Villars-sur-Glâne Fribourg

Sponsors (4)

Lead Sponsor Collaborator
Insel Gruppe AG, University Hospital Bern Hôpital Fribourgeois, Kantonsspital Baden, Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Other 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)
Other Patient opinion on comfort and practicability of the StepWatch and GENEActiv accelerometers Outcome of the pilot study only. Assessment through semi-structured interview Discharge (-1 to +2 days after discharge)
Other 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)
Primary 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 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
Secondary Activities of Daily Living Measured by the Barthel Index by telephone interview of the participant/relatives Day 30 (+/-5) after enrollment
Secondary Activities of Daily Living Measured by the Barthel Index by telephone interview of the participant/relatives Day 180 (+/-5) after enrollment
Secondary Instrumental Activities of Daily Living Measured by the Lawton Index by telephone interview of the participant/relatives Day 30 (+/-5) after enrollment
Secondary Instrumental Activities of Daily Living Measured by the Lawton Index by telephone interview of the participant/relatives Day 180 (+/-5) after enrollment
Secondary 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
Secondary 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
Secondary Depression Measured by the Patient Health Questionnaire (PHQ)-2 by telephone interview of the participant/relatives Day 30 (+/-5) after enrollment
Secondary Depression Measured by the Patient Health Questionnaire (PHQ)-2 by telephone interview of the participant/relatives Day 180 (+/-5) after enrollment
Secondary Pressure ulcer Evaluated according to the NPUAP/EPUAP classification, based on nurse report and electronic health record Discharge (-1 to +2 days after discharge)
Secondary 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)
Secondary Mobility at discharge Measured by the de Morton Mobility Index (DEMMI); assessment conducted by the study team Discharge (maximum 1 day before)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary Fear of / concerns about falling Measured by the Falls Efficacy Scale - International by telephone interview of the participant/relatives Day 30 (+/-5) after enrollment
Secondary Fear of / concerns about falling Measured by the Falls Efficacy Scale - International by telephone interview of the participant/relatives Day 180 (+/-5) after enrollment
Secondary 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)
Secondary 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)]
Secondary 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
Secondary 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
Secondary 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)
Secondary 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)
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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)
Secondary Number of patients with new institutionalization within 30 days of discharge Assessed by telephone interview of the participant/relatives Day 30 (+/-5) after enrollment
Secondary Number of patients with new institutionalization within 180 days of discharge Assessed by telephone interview of the participant/relatives Day 180 (+/-5) after enrollment
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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)
Secondary Satisfaction with hospitalization Measured by the satisfaction questionnaire adapted and simplified Discharge (-1 to +2 days after discharge)
Secondary 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
Secondary Location at follow-up Assessed by telephone interview of patient/relatives. Day 30 (+/-5) after enrollment
Secondary Location at follow-up Assessed by telephone interview of patient/relatives. Day 180 (+/-5) after enrollment
Secondary Discharge destination Assessed based on electronic health records Discharge (-1 to +2 days after discharge)
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