Technology Assisted Nudging to Increase Physical Activity Among Hospitalised Medical Patients
SENS4ME
1 other identifier
interventional
130
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2024
CompletedFirst Posted
Study publicly available on registry
March 28, 2024
CompletedStudy Start
First participant enrolled
May 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 7, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 7, 2025
CompletedSeptember 4, 2025
August 1, 2025
1.1 years
March 13, 2024
August 27, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Time spent out of bed measured in minutes related to the total accelerometer wear time (minutes)
To assess physical activity a small tri-axial accelerometers is used. The accelerometer measures activity data in minutes per day.
3 month
Secondary Outcomes (7)
Readmission within 90 days
3 month
Length of stay (days)
3 month assessment
Time spent lying down, sitting, standing, and walking measured in minutes related to the total accelerometer wear time (minutes)
3 month
Time spent out of bed in hospital in minutes related to the total accelerometer wear time (minutes)
3 month assessment
Time spent out of bed after discharge in minutes related to the total accelerometer wear time (minutes)
3 month
- +2 more secondary outcomes
Study Arms (2)
Arm 1 digital nudging
EXPERIMENTALIn hospital Participants in the intervention group will receive usual hospital care and be provided with a sensor collecting data on physical activity level during hospitalisation AND a monitor placed at their bedside that displays information about their physical activity level, in terms of time spent bedridden, sitting, standing, and walking. This information will be visible to the health personnel, the patients, and their relatives. This feedback system is developed and provided by SENS Innovation. After discharge The visual feedback system from SENS will be continued after discharge and include an E-sport biking system provided by 4Mvideo. This integrated new system will combine an ergometer bike or sofa bike installed in the patient's own home or nursing home, and data from the sensor that the participants continue to wear after discharge will go into the SENS system, feeding back a visual track of their activities
Arm 2 usual care
NO INTERVENTIONThe participants in the non-exposed cohort will receive usual hospital care and be provided with a sensor collecting data on activity level during hospitalisation.
Interventions
In hospital Participants in the intervention group will receive usual hospital care and be provided with a sensor collecting data on physical activity level during hospitalisation AND a monitor placed at their bedside that displays information about their physical activity level, in terms of time spent bedridden, sitting, standing, and walking. This information will be visible to the health personnel, the patients, and their relatives. This feedback system is developed and provided by SENS Innovation. After discharge The visual feedback system from SENS will be continued after discharge and include an E-sport biking system provided by 4Mvideo. This integrated new system will combine an ergometer bike or sofa bike installed in the patient's own home or nursing home, and data from the sensor that the participants continue to wear after discharge will go into the SENS system, feeding back a visual track of their activities
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bispebjerg Hospitallead
- AALcollaborator
- Innovationsfondencollaborator
Study Sites (1)
Christian Dall
Copenhagen, 2400, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Morten T Kristensen, Professor
Bispebjerg Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Primary outcome (accelerometer data) blinded for the investigator and assesor.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
March 13, 2024
First Posted
March 28, 2024
Study Start
May 3, 2024
Primary Completion
June 7, 2025
Study Completion
June 7, 2025
Last Updated
September 4, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share
Due to Danish legislation