Effectiveness of an intervention to improve the movement of older patients during a hospital stay (the INTOMOB study)
Descrizione riassuntiva dello studio
We know that patients generally move too little during a hospital stay. It is often thought that one should stay in bed to recover. However, this is not true. Lack of movement during a hospital stay can quickly lead to negative consequences, such as muscle loss (5% per day in bed), bone loss, falls, confusion, constipation, and ultimately a decrease in independence, placement in nursing homes, and even increased mortality. Therefore, patients are advised to move as much as possible during a hospital stay, considering their health status and any potential movement restrictions. The main goal of movement in the hospital is not to exercise, but to maintain the pre-existing state of independence. We have developed an intervention that aims to help patients move as much as possible during their hospital stay. The study is divided into two parts. To verify the feasibility of the study, we first conduct a so-called “pilot study” with 20 individuals. The pilot study serves to improve the intervention for the main study. Subsequently, the main study will follow, in which we want to find out whether the intervention can increase movement and reduce the consequences of lack of movement. One group participating in the intervention (“intervention group”) will be compared with a group that does not participate (“control group”). We investigate the effectiveness of the intervention on the following: - Range of motion 1 and 6 months after the start of the study - Movement in the hospital - Muscle strength, skin ulcers - Falls during and after the hospital stay - Discharge location after hospital stay - Daily activities, quality of life, mood, placement in nursing homes, emergency visits, readmissions, and mortality within 6 months after the start of the study.
(BASEC)
Intervento studiato
The intervention being studied has 3 components: 1) Intervention for patients; 2) Intervention for doctors and nursing staff; 3) Modification of the hospital environment.
The intervention for PATIENTS includes:
1) A brochure with information about movement (including what, when, how, how often, where) and the lack of movement in the hospital, as well as advice and concrete suggestions;
2) A movement diary where patients can record their individual movement goals with the help of healthcare staff, as well as their results, difficulties, and needs;
3) An exercise brochure: photos with instructions for 29 movement exercises in lying, sitting, and standing positions.
4) An iPad 10.2'' with access to videos of the 29 exercises.
Additionally, patients in both groups (intervention group and control group) wear a pedometer.
Active participation (intervention) occurs only during the hospital stay. One and 6 months after the start of the study, patients will be contacted by phone to inquire about the endpoints of the study. After that, the study will be completed.
The intervention for DOCTORS and NURSING STAFF includes:
1) E-learning on movement in the hospital, including videos on motivational communication regarding movement in the hospital.
2) A checklist for the visit, so that the topic of movement is systematically addressed.
3) An oral presentation by the investigator.
The ENVIRONMENT will be modified to promote the movement of patients, making walking more patient-friendly. Posters on various topics (e.g., nutrition and sleep in the elderly, hospital staff, movement) and images (of landscapes, animals, plants, famous people) will be displayed on the wards.
(BASEC)
Malattie studiate
The INTOMOB study focuses on the movement of older patients during a hospital stay in general internal medicine. Movement does not mean exercise, but any type of movement as opposed to bed rest or sitting.
(BASEC)
- Age over 60 years - Mobile before the hospital stay - Not in a nursing home prior to hospitalization (BASEC)
Criteri di esclusione
- Movement not allowed during the hospital stay (bed rest prescribed by a doctor) - end of life - Confusion (BASEC)
Luogo dello studio
Aarau, Berna, Friburgo
(BASEC)
Sponsor
Prof. Dr. med. Carole E. Aubert
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Prof. Dr. med. Carole E. Aubert
+41 31 664 24 34
caroleelodie.aubert@clutterinsel.chBern University Hospital (Inselspital)
(BASEC)
Informazioni generali
Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland,
+41 31 664 24 34
caroleelodie.aubert@clutterinsel.ch(ICTRP)
Informazioni scientifiche
Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland,
+41 31 664 24 34
caroleelodie.aubert@clutterinsel.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Berna
(BASEC)
Data di approvazione del comitato etico
28.11.2022
(BASEC)
ID di studio ICTRP
NCT05639231 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Impact of an INtervention TO increase MOBility in older hospitalized medical patients (INTOMOB): a cluster randomized controlled trial (BASEC)
Titolo accademico
Impact of an INtervention TO Increase MOBility in Older Hospitalized Medical Patients (INTOMOB): a Cluster Randomized Controlled Trial (ICTRP)
Titolo pubblico
An INtervention TO Improve MOBility of Older Hospitalized Patients (ICTRP)
Malattie studiate
Hospital Mobility;Mobility Limitation;Life-Space;Functional Status;Hospital-Acquired Condition;Muscle Atrophy or Weakness;Sarcopenia;Iatrogenic Disease (ICTRP)
Intervento studiato
Behavioral: INTOMOB intervention (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Outcomes Assessor). (ICTRP)
Criteri di inclusione/esclusione
Gender: All
Maximum age: N/A
Minimum age: 60 Years
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
(ICTRP)
non disponibile
Endpoint primari e secondari
Life-space level (ICTRP)
Life-space level;Activities of Daily Living;Activities of Daily Living;Instrumental Activities of Daily Living;Instrumental Activities of Daily Living;Quality of life (EQ-5D);Quality of life (EQ-5D);Depression;Depression;Pressure ulcer;Delirium during hospitalization (hospitalization duration expected to be 3 to 20 days on average);Mobility at discharge;Lower-limb muscle strength;Hand-grip muscle strength;Step count during hospitalization (hospitalization duration expected to be 3 to 20 days on average);Level of activity during hospitalization (hospitalization duration expected to be 3 to 20 days on average);Fear of / concerns about falling;Fear of / concerns about falling;Fear of / concerns about falling;Fall-risk increasing drugs;Fall-risk increasing drugs during hospitalization;Fall-risk increasing drugs;Fall-risk increasing drugs;Number of patients with fall(s) during hospitalization (hospitalization duration expected to be 3 to 20 days on average);Number of falls per patient during hospitalization (hospitalization duration expected to be 3 to 20 days on average);Number of patients with fall(s) within 30 days after discharge;Number of falls per patient within 30 days after discharge;Number of patients with fall(s) within 180 days after discharge;Number of falls per patient within 180 days after discharge;Number of patients with new institutionalization at discharge;Number of patients with new institutionalization within 30 days of discharge;Number of patients with new institutionalization within 180 days of discharge;Number of patients with emergency room visits within 30 days of discharge;Number of emergency room visits per patient within 30 days of discharge;Number of patients with emergency room visits within 180 days of discharge;Number of emergency room visits per patient within 180 days of discharge;Number of patients with readmission within 30 days of discharge;Number of readmissions per patient within 30 days of discharge;Number of patients with readmission within 180 days of discharge;Number of readmissions per patient within 180 days of discharge;Experience of the intervention;Satisfaction with hospitalization;Perspectives on hospital mobility;Location at follow-up;Location at follow-up;Discharge destination (ICTRP)
Data di registrazione
28.11.2022 (ICTRP)
Inclusione del primo partecipante
non disponibile
Sponsor secondari
Swiss National Science Foundation;H?pital Fribourgeois;Kantonsspital Baden (ICTRP)
Contatti aggiuntivi
Carole E Aubert, MD, MSc;Carole E Aubert, MD, MSc, caroleelodie.aubert@insel.ch, +41 31 664 24 34, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland, (ICTRP)
ID secondari
2022-01568 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT05639231 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile