COPDSENS4MENCT06336252
Technology Assisted Nudging to Increase Physical Activity Among Hospitalised Medical Patients
A study testing Digital nudging intervention target to change behavior in people with COPD and Heart Failure, run by Bispebjerg Hospital at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- COPD, Heart Failure, Parkinson Disease
- What is being tested?
- Digital nudging intervention target to change behavior
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteDenmark
- Study dates
- 3 May 2024to 7 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Technology Assisted Nudging to Increase Physical Activity Among Hospitalised Medical Patients in Hospital and 3 Months After Discharge
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.
Read the 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 he/she is discharged and followed for 3 months.
- Conditions
- COPD, Heart Failure, Parkinson Disease, Arthritis, Old Age; Cachexia, Stroke Sequelae
- Being tested
- Digital nudging intervention target to change behavior
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Heart Failure, Parkinson Disease, Arthritis, Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital nudging intervention target to change behaviorBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 digital nudging | Experimental | 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 Receives: Behavioral: Digital nudging intervention target to change behavior |
| Arm 2 usual care | No intervention | The participants in the non-exposed cohort will receive usual hospital care and be provided with a sensor collecting data on activity level during hospitalisation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 month
Secondary outcomes (7)
Readmission within 90 days
Number of readmissions 90 days following discharge
Measured: 3 month
Length of stay (days)
Days of hospitalization
Measured: 3 month assessment
Time spent lying down, sitting, standing, and walking measured in minutes related to the total accelerometer wear time (minutes)
Measured by objective accelerometer
Measured: 3 month
Time spent out of bed in hospital in minutes related to the total accelerometer wear time (minutes)
Measured by objective accelerometer
Measured: 3 month assessment
Time spent out of bed after discharge in minutes related to the total accelerometer wear time (minutes)
Measured by objective accelerometer
Measured: 3 month
Quality of life (EQ5D-5L)
PROM quality of life, increase means better quality of life score
Measured: 3 month
- In-hospital fall incidents
Number of falls
Measured: 3 month assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start3 May 2024
- Primary completion7 Jun 2025
- Study completion7 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1/1 allocation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- AAL, Innovationsfonden
- Responsible party
- Principal investigator, Christian Dall, Bispebjerg Hospital
- Investigators
- Morten T Kristensen, Professor, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06336252
- Sponsor's protocol ID
- F-23059441
- Acronym
- SENS4ME
- Status last verified
- Jul 2026
- First submitted
- 13 Mar 2024
- Last updated
- 7 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to Danish legislation
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology Assisted Nudging to Increase Physical Activity Among Hospitalised Medical Patients in Hospital and 3 Months After Discharge
- ClinicalTrials.gov ID
- NCT06336252
- Acronym / sponsor ID
- SENS4ME / F-23059441
- Conditions
- COPD, Heart Failure, Parkinson Disease, Arthritis, Old Age; Cachexia, Stroke Sequelae
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- AAL, Innovationsfonden
- Study start
- 3 May 2024 (actual)
- Primary completion
- 7 Jun 2025 (actual)
- Study completion
- 7 Jun 2025 (actual)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 he/she is discharged and followed for 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 1/1 allocation
| Arm | Type | Receives |
|---|---|---|
| Arm 1 digital nudging | Experimental | Behavioral: Digital nudging intervention target to change behaviorIn 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 intervention | –The participants in the non-exposed cohort will receive usual hospital care and be provided with a sensor collecting data on activity level during hospitalisation. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital nudging intervention target to change behaviorIn 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 | Behavioural | Arm 1 digital nudging |
Primary outcome
Time spent out of bed measured in minutes related to the total accelerometer wear time (minutes)
Time frame: 3 month
To assess physical activity a small tri-axial accelerometers is used. The accelerometer measures activity data in minutes per day.
7 secondary outcomes
Readmission within 90 days
Time frame: 3 month
Length of stay (days)
Time frame: 3 month assessment
Time spent lying down, sitting, standing, and walking measured in minutes related to the total accelerometer wear time (minutes)
Time frame: 3 month
Time spent out of bed in hospital in minutes related to the total accelerometer wear time (minutes)
Time frame: 3 month assessment
Time spent out of bed after discharge in minutes related to the total accelerometer wear time (minutes)
Time frame: 3 month
Quality of life (EQ5D-5L)
Time frame: 3 month
- In-hospital fall incidents
Time frame: 3 month assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No. Due to Danish legislation
Related trials for COPD
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morten T Kristensen, Professor principal investigator
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital nudging intervention target to change behavior in people with COPD and Heart Failure, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time spent out of bed measured in minutes related to the total accelerometer wear time (minutes) (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.