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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Arthritis; Parkinson Disease; Stroke Sequelae; COPD; Old Age; Cachexia
• Intervention / Treatment: Behavioral: Digital nudging intervention target to change behavior

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 Type: Interventional
• Enrollment (Estimated): 162
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christian Have Dall, PhD; Phone Number: +4528604402; Email: christian.have.dall@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2400
    • Recruiting
    • Christian Dall
    • Contact: Christian H Dall, PhD; Phone Number: 00 45 28604402; Email: christian.have.dall@regionh.dk
    • Contact: Morten T Kristensen, Professor; Phone Number: 0045 38635000; Email: morten.tange.kristensen@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Aged ≥60

1. Is admitted to one of the participating departments
2. Has signed informed consent
3. 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:

1. 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)
2. Expected hospitalisation less than 24 hours
3. Has allergy towards band aid
4. 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1 digital nudging; 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	Behavioral: Digital nudging intervention target to change behavior; 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
No Intervention: Arm 2 usual care; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Readmission within 90 days	Number of readmissions 90 days following discharge	3 month
Length of stay (days)	Days of hospitalization	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	3 month
Time spent out of bed in hospital in minutes related to the total accelerometer wear time (minutes)	Measured by objective accelerometer	3 month assessment
Time spent out of bed after discharge in minutes related to the total accelerometer wear time (minutes)	Measured by objective accelerometer	3 month
Quality of life (EQ5D-5L)	PROM quality of life, increase means better quality of life score	3 month
- In-hospital fall incidents	Number of falls	3 month assessment

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital
• Collaborators: AAL; Innovationsfonden
• Investigators: Principal Investigator: Morten T Kristensen, Professor, Bispebjerg Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): December 20, 2025
• Study Completion (Estimated): June 20, 2026

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: March 26, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Body Weight; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Body Weight Changes; Weight Loss; Thinness; Parkinson Disease; Cachexia
• Other Study ID Numbers: F-23059441

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to Danish legislation

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No