Technology Assisted Nudging to Increase Physical Activity Among Hospitalised Medical Patients

STUDY DESIGN Description of the protocol The study will be conducted as a randomised multicentre trial including 3 hospitals in Europe (Copenhagen, Stavanger, and Genova). Patients admitted to Department of Respiratory Medicine, Department of Cardiology, and Department of Geriatrics, Department of Orthopaedic disease or Department of Neurology will be included, and they will have their physical activity level measured either with or without a monitor providing visual feedback of time spent bedridden, sitting, standing, and walking. After discharge the feedback will include an ergometer bike or sofa bike connected to the feedback mechanism.

Design A randomised multicentre study design is chosen. All participants will have their physical activity measured during hospitalisation and after discharge. Approximately half of the participants will receive visual feedback about the amount of physical activity from a mobile device placed on the bedside table while hospitalized, and after discharge, they will be provided with an ergometer bike or sofa bike connected to the feedback mechanism.

Allocation of participants The allocation of participants will be done 1 to 1, stratified by age group, gender, and level of mobility, to the control group (no feedback) and intervention group (visual feedback group). We schedule, that 162 patients will be possible to include in the analysis set (54 patients are planned to be included in Denmark, Norway, and Italy). A computer-generated randomisation sequence will be used to assign the participants in each site to the intervention and control arms.

Duration of study participation Each participant will be observed from admission of hospitalisation or until he/she is discharged and followed for 3 months.

Inclusion criteria

An individual will be eligible for study participation if he/she meets the following criteria:

Aged ≥60

• Is admitted to one of the participating departments
• Has signed informed consent
• Reads and speaks Danish, Norwegian, Italian, or English

Exclusion criteria

An individual will be excluded from the study if he/she meets any of the following criteria:

• Any condition that, in the opinion of the investigator, makes the person unfit for participation, e.g., delirium and/or psychotic symptoms; moderate or severe depression (GDS>8 (short form)); major surgery; moderate/severe dementia (MoCA≤18); chemotherapy or radiation treatment ongoing at enrolment; moderate/severe frailty (CFS≥6)
• Expected hospitalisation less than 24 hours
• Has allergy towards band aid
• Enrolled in any other clinical study within the duration of the current study.

While these criteria represent the criteria for being observed, only patients observed for at least 24 hours are included in the analysis population. For practical reasons it is not possible to predict those patients eligible for the analysis population at inclusion. Hence, we will monitor more patients than we will analyse (see statistical analysis section).