GoMob-in: Goal-directed Mobilization of Medical Inpatients

Sponsor
University Hospital Inselspital, Berne (Other)
Overall Status
Recruiting
CT.gov ID
NCT04760392
Collaborator
University of Bern (Other)
160
1
2
15
10.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Goal-directed mobilization
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Goal-directed Mobilization of Medical Inpatients (GoMob-in) - a Randomized, Controlled Trial
Actual Study Start Date :
Sep 13, 2021
Anticipated Primary Completion Date :
Sep 15, 2022
Anticipated Study Completion Date :
Dec 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: GDM

Goal-directed mobilization

Behavioral: Goal-directed mobilization
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.

No Intervention: Control

Standard of care

Outcome Measures

Primary Outcome Measures

  1. Change from baseline of the DEMMI score [Day 5±1]

    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

  1. Change from baseline of the DEMMI score [Hospital discharge (max. day 14±1)]

    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

  2. Mobilization time [Day 5±1]

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

  3. Mobilization time [During hospitalization (max. 14±1 days)]

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

  4. Number of delirium episodes [During hospitalization (max. 14±1 days)]

    As recorded in the discharge letter and nurse's protocol

  5. Number of in-hospital falls [During hospitalization (max. 14±1 days)]

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

  6. Length-of-hospital-stay [3 months]

    Length-of-hospital-stay

  7. Total number of falls (with / without injuries) [3 months after study inclusion]

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

  8. Number of re-hospitalizations and all-cause mortality [3 months after study inclusion]

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

  9. Independence during activities of daily living: change in Barthel index between (German version) [3 months after study inclusion]

    By telephone interview with participant

  10. Concerns of falling: change in Falls Efficacy Scale - International (FES-I, German version) [3 months after study inclusion]

    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.

  11. Quality of life: change in EuroQol (EQ-5D-5L, German version) [3 months after study inclusion]

    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.

  12. Destination [3 months after study inclusion]

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

  13. Reaching MCID [Hospital discharge (max. day 14±1)]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Inselspital, Bern University Hospital Bern BE Switzerland CH-3010

Sponsors and Collaborators

  • University Hospital Inselspital, Berne
  • University of Bern

Investigators

  • Principal Investigator: Fabian D Liechti, MD-PhD, Dr. med., Inselspital, Bern University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT04760392
Other Study ID Numbers:
  • GoMob-in
First Posted:
Feb 18, 2021
Last Update Posted:
Apr 12, 2022
Last Verified:
Apr 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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 12, 2022