An INtervention TO Improve MOBility of Older Hospitalized Patients

Not Applicable

Recruiting

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

• Registration Number: NCT05639231
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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:

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-28
• Study First Submitted QC: 2022-11-28
• Study First Posted: 2022-12-06
• Study Start: 2022-12-15
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-28
• Primary Completion: 2024-11-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 294

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Life-space level	Day 30 (+/-5) after enrollment	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

Name	Time	Method
Depression	Day 180 (+/-5) after enrollment	Measured by the Patient Health Questionnaire (PHQ)-2 by telephone interview of the participant/relatives
Life-space level	Day 180 (+/-5) after enrollment	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	Day 180 (+/-5) after enrollment	Measured by the Barthel Index by telephone interview of the participant/relatives
Instrumental Activities of Daily Living	Day 180 (+/-5) after enrollment	Measured by the Lawton Index by telephone interview of the participant/relatives
Lower-limb muscle strength	Discharge (maximum 1 day before)	Measured by lower-limb manual testing according to the method by Hislop and Montgomery; assessment conducted by the study team
Level of activity during hospitalization (hospitalization duration expected to be 3 to 20 days on average)	Discharge (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)
Fall-risk increasing drugs	Day 180 (+/-5) after enrollment	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) within 30 days after discharge	Day 30 (+/-5) after enrollment	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	Day 30 (+/-5) after enrollment	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	Day 180 (+/-5) after enrollment	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 within 30 days of discharge	Day 30 (+/-5) after enrollment	Assessed by telephone interview of the participant/relatives
Quality of life (EQ-5D)	Day 180 (+/-5) after enrollment	Measured by the European Quality of Life-5 Dimensions (EQ-5D) questionnaire by telephone interview of the participant/relatives
Pressure ulcer	Discharge (-1 to +2 days after discharge)	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)	Discharge (-1 to +2 days after discharge)	Measured by the Confusion Assessment Method
Mobility at discharge	Discharge (maximum 1 day before)	Measured by the de Morton Mobility Index (DEMMI); assessment conducted by the study team
Step count during hospitalization (hospitalization duration expected to be 3 to 20 days on average)	Discharge (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)
Number of patients with new institutionalization at discharge	Discharge (-1 to +2 days after discharge)	According to nurses / electronic health record / self-report by participant/relatives
Number of emergency room visits per patient within 180 days of discharge	Day 180 (+/-5) after enrollment	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.
Hand-grip muscle strength	Discharge (maximum 1 day before)	Measured by JAMAR (for the pilot study) and SAEHAN (for the RCT) hand dynamometer; assessment conducted by the study team
Fear of / concerns about falling	Day 180 (+/-5) after enrollment	Measured by the Falls Efficacy Scale - International by telephone interview of the participant/relatives
Number of falls per patient within 180 days after discharge	Day 180 (+/-5) after enrollment	Assessed by telephone interview of the participant/relatives, based on a diary the participants/relatives will be asked to complete.
Number of patients with emergency room visits within 30 days of discharge	Day 30 (+/-5) after enrollment	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	Day 30 (+/-5) after enrollment	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	Day 30 (+/-5) after enrollment	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	Day 30 (+/-5) after enrollment	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.
Satisfaction with hospitalization	Discharge (-1 to +2 days after discharge)	Measured by the satisfaction questionnaire adapted and simplified
Perspectives on hospital mobility	Day 30 (+/-5) after enrollment	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	Day 180 (+/-5) after enrollment	Assessed by telephone interview of patient/relatives.
Fall-risk increasing drugs during hospitalization	Discharge (discharge letter) (hospitalization duration expected to be 3 to 20 days on average)]	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
Number of falls per patient during hospitalization (hospitalization duration expected to be 3 to 20 days on average)	Discharge (-1 to +2 days after discharge)	Based on nurse report and electronic health record data
Number of patients with new institutionalization within 180 days of discharge	Day 180 (+/-5) after enrollment	Assessed by telephone interview of the participant/relatives
Number of patients with readmission within 180 days of discharge	Day 180 (+/-5) after enrollment	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 fall(s) during hospitalization (hospitalization duration expected to be 3 to 20 days on average)	Discharge (-1 to +2 days after discharge)	Based on nurse report and electronic health record data
Number of patients with emergency room visits within 180 days of discharge	Day 180 (+/-5) after enrollment	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	Day 180 (+/-5) after enrollment	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	Discharge (-1 to +2 days after discharge)	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 destination	Discharge (-1 to +2 days after discharge)	Assessed based on electronic health records

Trial Locations

Locations (4)

Inselspital, Bern University Hospital, InselGruppe AG; 🇨🇭 Bern, Switzerland

Spital Tiefenau, InselGruppe AG; 🇨🇭 Bern, Switzerland

HFR-Fribourg - hôpital cantonal; 🇨🇭 Villars-sur-Glâne, Fribourg, Switzerland

Kantonsspital Baden; 🇨🇭 Baden, Aargau, Switzerland