Goal-directed Mobilization of Medical Inpatients

Study Overview
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Brief Summary
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Immobilization in general internal medicine inpatients is a major contributor to morbidity and mortality. Goal-directed mobilization (GDM) may improve mobility. The aim of this study is to assess, if GDM increases physical activity (DEMMI score) during hospitalization and improves quality of care until 3 months after hospitalization.

Official Title
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Goal-directed Mobilization of Medical Inpatients (GoMob-in) - a Randomized, Controlled Trial

Conditions
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Immobility Syndrome, Fall, Delirium, Sarcopenia, Mobility Limitation, Hospital Acquired Condition

Intervention / Treatment
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* Behavioral: Goal-directed mobilization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All consenting patients aged ≥ 18 years admitted to the Department of General Internal Medicine, Inselspital, Bern University Hospital, Bern, Switzerland, who have an indication for physiotherapy (prescription by the resident in charge or the care coordinator). Participants must be randomized at latest on the second day after hospital admission. Written informed consent. Exclusion Criteria: Inability to follow study procedures, i.e., due to language problems (unable to read, speak or understand German), psychological disorders, severe dementia (defined as to levels 5 - 7 in the Global Deterioration Scale), blindness, Patients unable to provide informed consent themselves Expected hospital stay for < 5 days Medically indicated bedrest for more than 24 h, e.g. after surgery Injuries or neurologic deficits of one or both lower extremities directly impairing walking capacity (e.g. fractures, hemiplegia, previous use of a wheelchair or bedriddenness) Terminal illness Pregnancy or breast feeding Previous enrolment in this study Enrolment of the investigator, his/her family members, employees and other dependent persons

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GDM<br>Goal-directed mobilization | Behavioral: Goal-directed mobilization<br>* A short educational intervention with handout of a leaflet on GDM. Definition of personal mobility goal level. Communication of the mobility goal level to involved stakeholders. Regular reassessment of the mobility goal level and booster sessions by physiotherapists.<br>|
| No Intervention: Control<br>Standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of the DEMMI score | Change of the de Morton Mobility Index (DEMMI) score (range 0 to 100 with 0 indicating poor physical activity and 100 indicating a high level of independent physical activity) from baseline (at study inclusion), assessed by independent, blinded physiotherapist | Day 5±2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of the DEMMI score | Change of the de Morton Mobility Index (DEMMI) score (range 0 to 100 with 0 indicating poor physical activity and 100 indicating a high level of independent physical activity) from baseline (at study inclusion), assessed by independent, blinded physiotherapist | Hospital discharge (max. day 14±2) | 
| Mobilization time | Mobilization time measured by accelerometer (i.e., time moving as total of time inactive and static, excluding time not worn) | Day 5±2 | 
| Mobilization time | Mobilization time measured by accelerometer (i.e., time moving as total of time inactive and static, excluding time not worn) | During hospitalization (max. 14±2 days) | 
| Number of delirium episodes | As recorded in the discharge letter and nurse's protocol | During hospitalization (max. 14±2 days) | 
| Number of in-hospital falls | As recorded in the nurse's protocol (fall protocol) | During hospitalization (max. 14±2 days) | 
| Length-of-hospital-stay | Length-of-hospital-stay | 3 months | 
| Total number of falls (with / without injuries) | By telephone interview with participant (if not available the patients next of kin or family doctor) | 3 months after study inclusion | 
| Number of re-hospitalizations and all-cause mortality | By telephone interview with participant (if not available the patients next of kin or family doctor) | 3 months after study inclusion | 
| Independence during activities of daily living: change in Barthel index between (German version) | By telephone interview with participant | 3 months after study inclusion | 
| Concerns of falling: change in Falls Efficacy Scale - International (FES-I, German version) | Change (range 16 to 64 with 16 indicating no fear of falling and 64 indicating a high level of fear of falling) from baseline (at study inclusion), assessed by telephone interview with participant. | 3 months after study inclusion | 
| Quality of life: change in EuroQol (EQ-5D-5L, German version) | Change (range from 0 to 100 with 0 indicating no problem and indicating 100 extreme problems) from baseline (at study inclusion), assessed by telephone interview with participant. | 3 months after study inclusion | 
| Destination | Destination may include: death, acute care hospital, rehabilitation, home, nursing home, others | 3 months after study inclusion | 
| Reaching MCID | Reaching the minimal clinically important difference (MCID) of a change in DEMMI score (9 points) between baseline and discharge | Hospital discharge (max. day 14±2) |