Technology Assisted Nudging to Increase Physical Activity Among Hospitalised Medical Patients — SENS4ME  

Heart Failure Clinical Trial

Official title: Technology Assisted Nudging to Increase Physical Activity Among Hospitalised Medical Patients in Hospital and 3 Months After Discharge

Status Recruiting

Clinical Trial Summary

Primary Objective To investigate if patients hospitalised for older adults with a decreased level of physical function, either related to a chronic condition e.g., COPD, Congestive heart failure, renal failure; infections; frailty and tendency of falling; orthopaedic surgery - after hip fracture will increase their time spent out of bed during hospitalisation and 3 months after discharge through visual feedback and motivational intervention about physical activities from a new mobile technology.

Hypothesis Patients hospitalised for medical disease will increase their physical activity level during hospitalisation and 3 months after discharge through visual feedback and motivational intervention from a new mobile technology.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Arthritis
• Cachexia
• COPD
• Heart Failure
• Parkinson Disease
• Stroke Sequelae

• NCT number: NCT06336252
• Study type: Interventional
• Source: Bispebjerg Hospital
• Contact: Christian Have Dall, PhD
• Phone: +4528604402
• Email: christian.have.dall@regionh.dk
• Status: Recruiting
• Phase: N/A
• Start date: April 2024
• Completion date: June 20, 2026