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Goal-directed Mobilization of Medical Inpatients (GoMob-in)

Primary Purpose

Immobility Syndrome, Fall, Delirium

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Goal-directed mobilization

About this trial

This is an interventional prevention trial for Immobility Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
A participant in the same patient room
Enrolment of the investigator, his/her family members, employees and other dependent persons

Sites / Locations

Inselspital, Bern University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

GDM

Control

Arm Description

Goal-directed mobilization

Standard of care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline of the DEMMI score

Mobilization time

Mobilization time measured by accelerometer (i.e., time "moving" as total of time "inactive" and "static", excluding time "not worn")

Mobilization time

Mobilization time measured by accelerometer (i.e., time "moving" as total of time "inactive" and "static", excluding time "not worn")

Number of delirium episodes

As recorded in the discharge letter and nurse's protocol

Number of in-hospital falls

As recorded in the nurse's protocol ("fall protocol")

Length-of-hospital-stay

Total number of falls (with / without injuries)

By telephone interview with participant (if not available the patients next of kin or family doctor)

Number of re-hospitalizations and all-cause mortality

By telephone interview with participant (if not available the patients next of kin or family doctor)

Independence during activities of daily living: change in Barthel index between (German version)

By telephone interview with participant

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.

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.

Destination

Destination may include: death, acute care hospital, rehabilitation, home, nursing home, others

Reaching MCID

Reaching the minimal clinically important difference (MCID) of a change in DEMMI score (9 points) between baseline and discharge

Full Information

NCT ID

NCT04760392

First Posted

February 8, 2021

Last Updated

September 28, 2023

Sponsor

Insel Gruppe AG, University Hospital Bern

Collaborators

University of Bern

1. Study Identification

Unique Protocol Identification Number

NCT04760392

Brief Title

Goal-directed Mobilization of Medical Inpatients

Acronym

GoMob-in

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

September 13, 2021 (Actual)

Primary Completion Date

January 23, 2023 (Actual)

Study Completion Date

April 18, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Insel Gruppe AG, University Hospital Bern

Collaborators

University of Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

160 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GDM

Arm Type

Experimental

Arm Description

Goal-directed mobilization

Arm Title

Control

Arm Type

No Intervention

Arm Description

Standard of care

Intervention Type

Behavioral

Intervention Name(s)

Goal-directed mobilization

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change from baseline of the DEMMI score

Description

Time Frame

Day 5±2

Secondary Outcome Measure Information:

Title

Change from baseline of the DEMMI score

Description

Time Frame

Hospital discharge (max. day 14±2)

Title

Mobilization time

Description

Mobilization time measured by accelerometer (i.e., time "moving" as total of time "inactive" and "static", excluding time "not worn")

Time Frame

Day 5±2

Title

Mobilization time

Description

Mobilization time measured by accelerometer (i.e., time "moving" as total of time "inactive" and "static", excluding time "not worn")

Time Frame

During hospitalization (max. 14±2 days)

Title

Number of delirium episodes

Description

As recorded in the discharge letter and nurse's protocol

Time Frame

During hospitalization (max. 14±2 days)

Title

Number of in-hospital falls

Description

As recorded in the nurse's protocol ("fall protocol")

Time Frame

During hospitalization (max. 14±2 days)

Title

Length-of-hospital-stay

Description

Length-of-hospital-stay

Time Frame

3 months

Title

Total number of falls (with / without injuries)

Description

By telephone interview with participant (if not available the patients next of kin or family doctor)

Time Frame