Effectiveness of Hospital Fit on physical activity of hospitalised patients: a stepped-wedge cluster-randomised clinical trial and process evaluation.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 180

Inclusion Criteria

Inclusion criteria patients (n<=180):
In order to be eligible to participate in this study, a patient must meet all
the following criteria:
* Over 18 years old.
* Receiving physiotherapy at the Medical Oncology department or the Cardiology
department at the MUMC+ or Radboudumc.
* Enough understanding of the Dutch language.
* Owning a smartphone (operating system * iOS13.0 or Android 8.0)
* Able to use a smartphone app
* Able to walk independently 2 weeks before admission, as scored on the
Functional Ambulation Categories (FAC >3)

Inclusion criteria healthcare professionals (n<=24):
In order to be eligible to participate in the focus group interviews of the
proces-evaluation, a healthcare professional must meet all the following
criteria:
* Employed as physiotherapist, nurse or physician (assistant) at the Medical
Oncology Department or the Cardiology Department.
* Working at the MUMC+ or Radboudumc for at least one month.

Exclusion Criteria

Exclusion criteria patients:
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
* A contraindication to walking (as reported by a medical specialist in the
electronic medical record).
* A contraindication to wearing an activity monitor, fixed by a hypoallergenic
plaster at the upper leg (such as active bilateral upper leg infection, severe
oedema or bilateral transfemoral amputation).
* Admitted for cancers of the head and neck (i.e., cancer in the oral cavity,
throat (pharynx), voice box (larynx), paranasal sinuses and nasal cavity,
salivary glands).
* Admitted with cardiac arrhythmia and hemodynamic instability requiring
medication over 48 hours (i.e., beta blockers or noradrenaline) or invasive
treatment (i.e., pacemaker or defibrillator implementation).
* Mentally incapacitated subjects as reported by healthcare professionals in
the medical record. When any doubt arises, the patient will be excluded.
* Impaired cognition (delirium / dementia) as reported in the medical record by
a healthcare professional. When any doubt arises, the patient will be excluded.
* Unable to participate in the informed consent procedure or unable to provide
written informed consent.
* A life expectancy shorter than 3 months as mentioned by the medical
specialist in the medical record.
* Previous participation in this study.

Exclusion criteria healthcare professionals:
* No participation in care for patients at the Medical oncology Department or
Cardiology Department during the intervention phase (e.g., absence or research
employment).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome parameter: average time spent walking per day (min). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome parameters: average time spent standing and lying/sitting per<br /><br>day (min.), average number of transitions from lying/sitting to<br /><br>standing/walking per day, and mILAS score per day. Outcome parameters process<br /><br>evaluation: participation; representation; perceived efficacy; use of app; use<br /><br>of different functionalities; barriers and facilitators to Hospital Fit use;<br /><br>and expected maintenance.</p><br>