Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06336252
Status:
RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-03-13
Brief Title:
Technology Assisted Nudging to Increase Physical Activity Among Hospitalised Medical Patients
Sponsor:
Bispebjerg Hospital
Organization:
Bispebjerg Hospital
Study Overview
Official Title:
Technology Assisted Nudging to Increase Physical Activity Among Hospitalised Medical Patients in Hospital and 3 Months After Discharge
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SENS4ME
Brief Summary:
Primary Objective To investigate if patients hospitalised for older adults with a decreased level of physical function either related to a chronic condition eg 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
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
Detailed 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 heshe is discharged and followed for 3 months
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 heshe is discharged and followed for 3 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None