Goal-directed mobilization of hospitalized patients
Zusammenfassung der Studie
This study is being conducted at the Department of General Internal Medicine at Inselspital Bern. We plan to include 160 individuals in the study. In this study, we aim to clarify whether clear communication and the specification of an individual daily goal can improve the mobility of hospitalized individuals. Participants will be randomly assigned to one of 2 groups: a motivation group and a control group. To measure movements, participants will wear a pedometer during their hospital stay. This device measures movements, from which a computer program can calculate whether participants are sleeping, standing, sitting, or walking. In the motivation group, patients will be instructed each day on how much they should move at a minimum. In the control group, patients move independently of a daily goal.
(BASEC)
Untersuchte Intervention
After consenting to participate in the study, an entry interview and examination will be conducted. This includes the following:
- Verification of the study's inclusion and exclusion criteria
- Questions about yourself such as height, weight, place of residence, walking aids, etc.
- Questionnaire on gait insecurity, independence, and quality of life (approximately 30 min)
- Physical examination of your mobility (approximately 10-15 min)
No additional blood draws or X-ray examinations are necessary for the study. The mobility assessment will be repeated on day 5, before hospital discharge or at the latest after 14 days.
We will also extract health information such as diagnoses, medications taken, and falls from the electronic medical record after discharge.
We will provide a fall diary to take home, where participants can document any falls. After 3 months, we will contact study participants by phone to ask some health-related questions (questionnaire on quality of life, gait insecurity, independence, current place of residence, etc.). If we are repeatedly unable to reach participants, we will contact their relatives or their primary care physician to clarify these questions.
Active participation lasts as long as the hospital stay, but at most 14 days, and is completed with a questionnaire that will be answered by phone after 3 months.
(BASEC)
Untersuchte Krankheit(en)
Lack of movement in hospitalized patients leads to increased falls and longer hospital stays. The study investigates how the mobility of patients in the hospital could be improved. We conduct this study to find out whether daily goal setting for hospitalized patients improves mobility, quality of life, and survival, and reduces falls, confusion, and readmissions to the hospital.
(BASEC)
All individuals who are hospitalized in the general internal medicine ward of Inselspital (admission less than two days ago) and have received a prescription for physiotherapy from the attending physician can participate. Additionally, you must be able to understand and sign this informed consent. (BASEC)
Ausschlusskriterien
Individuals who are expected to be hospitalized for less than 5 days, who have a relevant mobility restriction (such as a leg fracture or stroke), who have been ordered bed rest by a physician, or who are pregnant/breastfeeding are not eligible to participate. (BASEC)
Studienstandort
Bern
(BASEC)
Sponsor
nicht verfügbar
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Fabian Liechti
+41 31 632 21 11 / 181-7253
fabian.liechti@clutterinsel.ch(BASEC)
Allgemeine Auskünfte
Inselspital, Bern University Hospital
(ICTRP)
Wissenschaftliche Auskünfte
Inselspital, Bern University Hospital
(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Bern
(BASEC)
Datum der Bewilligung durch die Ethikkommission
01.03.2021
(BASEC)
ICTRP Studien-ID
NCT04760392 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
nicht verfügbar
Wissenschaftlicher Titel
Goal-directed Mobilization of Medical Inpatients (GoMob-in) - a Randomized, Controlled Trial (ICTRP)
Öffentlicher Titel
Goal-directed Mobilization of Medical Inpatients (ICTRP)
Untersuchte Krankheit(en)
Immobility Syndrome;Fall;Delirium;Sarcopenia;Mobility Limitation;Hospital Acquired Condition (ICTRP)
Untersuchte Intervention
Behavioral: Goal-directed mobilization (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor). (ICTRP)
Ein-/Ausschlusskriterien
Gender: All
Maximum age: N/A
Minimum age: 18 Years
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
(ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Change from baseline of the DEMMI score (ICTRP)
Change from baseline of the DEMMI score;Mobilization time;Mobilization time;Number of delirium episodes;Number of in-hospital falls;Length-of-hospital-stay;Total number of falls (with / without injuries);Number of re-hospitalizations and all-cause mortality;Independence during activities of daily living: change in Barthel index between (German version);Concerns of falling: change in Falls Efficacy Scale - International (FES-I, German version);Quality of life: change in EuroQol (EQ-5D-5L, German version);Destination;Reaching MCID (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
University of Bern (ICTRP)
Weitere Kontakte
Fabian D Liechti, MD-PhD, Dr. med., Inselspital, Bern University Hospital (ICTRP)
Sekundäre IDs
GoMob-in (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT04760392 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar