NCT06336252

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 28, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

May 3, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2025

Completed
Last Updated

September 4, 2025

Status Verified

August 1, 2025

Enrollment Period

1.1 years

First QC Date

March 13, 2024

Last Update Submit

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

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

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.

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

Arm 1 digital nudging

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Christian Dall

Copenhagen, 2400, Denmark

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveHeart FailureParkinson DiseaseArthritisCachexia

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular DiseasesParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesJoint DiseasesMusculoskeletal DiseasesWeight LossBody Weight ChangesBody WeightSigns and SymptomsThinness

Study Officials

  • Morten T Kristensen, Professor

    Bispebjerg Hospital

    PRINCIPAL INVESTIGATOR

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
Model Details: 1/1 allocation
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

Locations