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Completed

NCT Number: NCT05639231

An INtervention TO Improve MOBility of Older Hospitalized Patients

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.

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Key information

Conditions

Hospital Mobility Asthenia Atrophy Behavior Disease Attributes Functional Status Hospital-Acquired Condition Iatrogenic Disease Life-Space Mobility Limitation Motor Activity Muscle Atrophy or Weakness Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kantonsspital Baden, Baden, Canton of Aargau, Switzerland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

INTOMOB intervention

Behavioral

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 outcomes

  1. Life-space level

    Time frame: 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 outcomes

  1. Life-space level

    Time frame: 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

  2. Activities of Daily Living

    Time frame: Day 30 (+/-5) after enrollment

    Measured by the Barthel Index by telephone interview of the participant/relatives

  3. Activities of Daily Living

    Time frame: Day 180 (+/-5) after enrollment

    Measured by the Barthel Index by telephone interview of the participant/relatives

  4. Instrumental Activities of Daily Living

    Time frame: Day 30 (+/-5) after enrollment

    Measured by the Lawton Index by telephone interview of the participant/relatives

  5. Instrumental Activities of Daily Living

    Time frame: Day 180 (+/-5) after enrollment

    Measured by the Lawton Index by telephone interview of the participant/relatives

  6. Quality of life (EQ-5D)

    Time frame: Day 30 (+/-5) after enrollment

    Measured by the European Quality of Life-5 Dimensions (EQ-5D) questionnaire by telephone interview of the participant/relatives

  7. Quality of life (EQ-5D)

    Time frame: Day 180 (+/-5) after enrollment

    Measured by the European Quality of Life-5 Dimensions (EQ-5D) questionnaire by telephone interview of the participant/relatives

  8. Depression

    Time frame: Day 30 (+/-5) after enrollment

    Measured by the Patient Health Questionnaire (PHQ)-2 by telephone interview of the participant/relatives

  9. Depression

    Time frame: Day 180 (+/-5) after enrollment

    Measured by the Patient Health Questionnaire (PHQ)-2 by telephone interview of the participant/relatives

  10. Pressure ulcer

    Time frame: Discharge (-1 to +2 days after discharge)

    Evaluated according to the NPUAP/EPUAP classification, based on nurse report and electronic health record

  11. Delirium during hospitalization (hospitalization duration expected to be 3 to 20 days on average)

    Time frame: Discharge (-1 to +2 days after discharge)

    Measured by the Confusion Assessment Method

  12. Mobility at discharge

    Time frame: Discharge (maximum 1 day before)

    Measured by the de Morton Mobility Index (DEMMI); assessment conducted by the study team

  13. Lower-limb muscle strength

    Time frame: 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

  14. Hand-grip muscle strength

    Time frame: 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

  15. Step count during hospitalization (hospitalization duration expected to be 3 to 20 days on average)

    Time frame: 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)

  16. Level of activity during hospitalization (hospitalization duration expected to be 3 to 20 days on average)

    Time frame: 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)

  17. Fear of / concerns about falling

    Time frame: Discharge (-1 to +2 days after discharge)

    Measured by the Falls Efficacy Scale - International by telephone interview of the participant/relatives

  18. Fear of / concerns about falling

    Time frame: Day 30 (+/-5) after enrollment

    Measured by the Falls Efficacy Scale - International by telephone interview of the participant/relatives

  19. Fear of / concerns about falling

    Time frame: Day 180 (+/-5) after enrollment

    Measured by the Falls Efficacy Scale - International by telephone interview of the participant/relatives

  20. Fall-risk increasing drugs

    Time frame: 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

  21. Fall-risk increasing drugs during hospitalization

    Time frame: 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

  22. Fall-risk increasing drugs

    Time frame: Day 30 (+/-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

  23. Fall-risk increasing drugs

    Time frame: 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

  24. Number of patients with fall(s) during hospitalization (hospitalization duration expected to be 3 to 20 days on average)

    Time frame: Discharge (-1 to +2 days after discharge)

    Based on nurse report and electronic health record data

  25. Number of falls per patient during hospitalization (hospitalization duration expected to be 3 to 20 days on average)

    Time frame: Discharge (-1 to +2 days after discharge)

    Based on nurse report and electronic health record data

  26. Number of patients with fall(s) within 30 days after discharge

    Time frame: 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.

  27. Number of falls per patient within 30 days after discharge

    Time frame: 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.

  28. Number of patients with fall(s) within 180 days after discharge

    Time frame: 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.

  29. Number of falls per patient within 180 days after discharge

    Time frame: 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.

  30. Number of patients with new institutionalization at discharge

    Time frame: Discharge (-1 to +2 days after discharge)

    According to nurses / electronic health record / self-report by participant/relatives

  31. Number of patients with new institutionalization within 30 days of discharge

    Time frame: Day 30 (+/-5) after enrollment

    Assessed by telephone interview of the participant/relatives

  32. Number of patients with new institutionalization within 180 days of discharge

    Time frame: Day 180 (+/-5) after enrollment

    Assessed by telephone interview of the participant/relatives

  33. Number of patients with emergency room visits within 30 days of discharge

    Time frame: 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.

  34. Number of emergency room visits per patient within 30 days of discharge

    Time frame: 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.

  35. Number of patients with emergency room visits within 180 days of discharge

    Time frame: 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.

  36. Number of emergency room visits per patient within 180 days of discharge

    Time frame: 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.

  37. Number of patients with readmission within 30 days of discharge

    Time frame: 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.

  38. Number of readmissions per patient within 30 days of discharge

    Time frame: 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.

  39. Number of patients with readmission within 180 days of discharge

    Time frame: 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.

  40. Number of readmissions per patient within 180 days of discharge

    Time frame: 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.

  41. Experience of the intervention

    Time frame: 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.

  42. Satisfaction with hospitalization

    Time frame: Discharge (-1 to +2 days after discharge)

    Measured by the satisfaction questionnaire adapted and simplified

  43. Perspectives on hospital mobility

    Time frame: 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).

  44. Location at follow-up

    Time frame: Day 30 (+/-5) after enrollment

    Assessed by telephone interview of patient/relatives.

  45. Location at follow-up

    Time frame: Day 180 (+/-5) after enrollment

    Assessed by telephone interview of patient/relatives.

  46. Discharge destination

    Time frame: Discharge (-1 to +2 days after discharge)

    Assessed based on electronic health records

Other outcomes

  1. Healthcare professional experience of the intervention and perspectives on hospital mobility

    Time frame: After cluster closure (on average 1 to 10 months, maximum 15 months)

    Semi-structured interview and survey (in the intervention group only)

  2. Patient opinion on comfort and practicability of the StepWatch and GENEActiv accelerometers

    Time frame: Discharge (-1 to +2 days after discharge)

    Outcome of the pilot study only. Assessment through semi-structured interview

  3. Patient opinion on comfort and practicability of the ActiGraph accelerometer

    Time frame: Discharge (-1 to +2 days after discharge)

    Outcome of the randomized trial only. Assessment through semi-structured interview

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • Hôpital Fribourgeois
  • Kantonsspital Baden
  • Swiss National Science Foundation

Registry information

Official study title

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

Acronym: INTOMOB

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 6, 2022
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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