Clinical trial NCT06336252: Technology Assisted Nudging to Increase Physical Activity Among Hospitalised Medical Patients
Official title: Technology Assisted Nudging to Increase Physical Activity Among Hospitalised Medical Patients in Hospital and 3 Months After Discharge
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: COPD
Heart Failure
Parkinson Disease
Arthritis
Old Age; Cachexia
Stroke Sequelae
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: AAL
name: Innovationsfonden
First posted: 2024-03-28
Enrollment: 162
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1/1 allocation
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Time spent out of bed measured in minutes related to the total accelerometer wear time (minutes)
timeFrame: 3 month
Secondary outcomes:
measure: Readmission within 90 days
timeFrame: 3 month
measure: Length of stay (days)
timeFrame: 3 month assessment
measure: Time spent lying down, sitting, standing, and walking measured in minutes related to the total accelerometer wear time (minutes)
timeFrame: 3 month
measure: Time spent out of bed in hospital in minutes related to the total accelerometer wear time (minutes)
timeFrame: 3 month assessment
measure: Time spent out of bed after discharge in minutes related to the total accelerometer wear time (minutes)
timeFrame: 3 month
measure: Quality of life (EQ5D-5L)
timeFrame: 3 month
measure: - In-hospital fall incidents
timeFrame: 3 month assessment
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Christian Dall
Study officials:
affiliation: Bispebjerg Hospital
name: Morten T Kristensen, Professor
role: PRINCIPAL_INVESTIGATOR
References: