INTOMOB: An Intervention to Improve Mobility of Older Hospitalized Patients

Sponsor
University Hospital Inselspital, Berne (Other)
Overall Status
Recruiting
CT.gov ID
NCT05639231
Collaborator
Swiss National Science Foundation (Other), Hôpital Fribourgeois (Other)
294
3
2
28.5
98
3.4

Study Details

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:
  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 with quizzes 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: INTOMOB intervention
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
294 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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).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:
Triple (Participant, Care Provider, Outcomes 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.
Primary Purpose:
Prevention
Official Title:
Impact of an INtervention TO Increase MOBility in Older Hospitalized Medical Patients (INTOMOB): a Cluster Randomized Controlled Trial
Actual Study Start Date :
Dec 15, 2022
Anticipated Primary Completion Date :
Nov 30, 2024
Anticipated Study Completion Date :
Apr 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: INTOMOB intervention

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

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 with quizzes in the wards.

No Intervention: Control

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.

Outcome Measures

Primary Outcome Measures

  1. Life-space level [Day 30 (+/-5) after enrollment]

    Measured by the University of Alabama at Birmingham Study of Aging Life-Space (range 0-120, with maximum being a higher score = better outcome). Assessment by telephone interview of the participant/relatives

Secondary Outcome Measures

  1. Life-space level [Day 180 (+/-5) after enrollment]

    Measured by the University of Alabama at Birmingham Study of Aging Life-Space Assessment by telephone interview of the participant/relatives

  2. Activities of Daily Living [Day 30 (+/-5) after enrollment]

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

  3. Activities of Daily Living [Day 180 (+/-5) after enrollment]

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

  4. Instrumental Activities of Daily Living [Day 30 (+/-5) after enrollment]

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

  5. Instrumental Activities of Daily Living [Day 180 (+/-5) after enrollment]

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

  6. Quality of life (EQ-5D) [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) [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 [Day 30 (+/-5) after enrollment]

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

  9. Depression [Day 180 (+/-5) after enrollment]

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

  10. Pressure ulcer [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) [Discharge (-1 to +2 days after discharge)]

    Measured by the Confusion Assessment Method

  12. Mobility at discharge [Discharge (maximum 1 day before)]

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

  13. 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

  14. Hand-grip muscle strength [Discharge (maximum 1 day before)]

    Measured by Jama dynamometer; assessment conducted by the study team

  15. 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)

  16. 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)

  17. Fear of / concerns about falling [Day 30 (+/-5) after enrollment]

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

  18. Fear of / concerns about falling [Day 180 (+/-5) after enrollment]

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

  19. Fall-risk increasing drugs [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

  20. Fall-risk increasing drugs [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

  21. 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

  22. 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

  23. 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

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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

  29. Number of patients with new institutionalization within 30 days of discharge [Day 30 (+/-5) after enrollment]

    Assessed by telephone interview of the participant/relatives

  30. Number of patients with new institutionalization within 180 days of discharge [Day 180 (+/-5) after enrollment]

    Assessed by telephone interview of the participant/relatives

  31. 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.

  32. 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.

  33. 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.

  34. 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.

  35. 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.

  36. 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.

  37. 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.

  38. 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.

  39. 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.

  40. Satisfaction with hospitalization [Discharge (-1 to +2 days after discharge)]

    Measured by the satisfaction questionnaire adapted and simplified

  41. 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).

Other Outcome Measures

  1. Healthcare professional experience of the intervention and perspectives on hospital mobility [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 [Discharge (-1 to +2 days after discharge)]

    Outcome of the pilot study only

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Admission to a general internal medicine 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 enrolment

  • Possibility to start the study within 48 hours after admission to the general internal medicine ward

  • Written informed consent signed by participant or proxy/legal representative in case of cognitive impairment

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 (presence of features 1 and 2, and either 3 or 4 of the CAM)

  • Dementia (Mini-Cog <3), except if a proxy can be actively involved in the intervention and provides consent (for the randomized trial only, not for the pilot study)

Contacts and Locations

Locations

Site City State Country Postal Code
1 HFR-Fribourg - hôpital cantonal Villars-sur-Glâne Fribourg Switzerland 1752
2 Spital Tiefenau, InselGruppe AG Bern Switzerland 3004
3 Inselspital, Bern University Hospital, InselGruppe AG Bern Switzerland 3010

Sponsors and Collaborators

  • University Hospital Inselspital, Berne
  • Swiss National Science Foundation
  • Hôpital Fribourgeois

Investigators

  • Principal Investigator: Carole E Aubert, MD, MSc, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT05639231
Other Study ID Numbers:
  • 2022-01568
First Posted:
Dec 6, 2022
Last Update Posted:
Dec 21, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital Inselspital, Berne
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 21, 2022