- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06983977
- Original Trial
Increasing Physical Activity Among Medical Inpatients by Digital Nudging of Patients and Staff (IPAMINA)
Increasing Physical Activity Among Medical Inpatients by Digital Nudging of Patients and Staff - A Cluster Randomised Multicentre Study
Sedentary behaviour among medical inpatients is strongly associated with hospital-associated functional decline and poses a severe threat to patients' functional capacity and independency. High human and socioeconomic costs underline the urgency to find solutions to this world-wide problem.
Objective: This multicentre study, including a total of 400 patients from Copenhagen, Aalborg, Tórshavn, and Nuuk, will assess the effect of a digital intervention that aims to reduce sedentary behaviour and increase physical activity in medical inpatients.
Intervention: Digital feedback and nudging regarding the patients' physical activity levels to patients and healthcare staff Design: Stepped-wedge cluster randomised multicentre trial Primary outcome: Daily average time of patients' physical activity (minutes).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Durita V Gunnarsson, PhD student, MSc.
- Phone Number: +45 26472857
- Email: durita.videroe.gunnarsson@regionh.dk
Study Locations
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Region Hovedstaden
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Copenhagen, Region Hovedstaden, Denmark
- Recruiting
- Bispebjerg Hospital
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Contact:
- Christian H Dall, Associate professor, PhD
- Phone Number: +45 28604402
- Email: Christian.Have.Dall@regionh.dk
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Contact:
- Dall
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Region Nordjylland
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Hobro, Region Nordjylland, Denmark
- Recruiting
- Aalborg University Hospital
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Contact:
- Michael S Rathleff, Professor, Dr. Med.
- Phone Number: +45 22117002
- Email: misr@hst.aau.dk
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Contact:
- Rathleff
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-
-
-
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Tórshavn, Faroe Islands
- Recruiting
- National Hospital
-
Contact:
- Durita V Gunnarsson, PhD student, MSc.
- Phone Number: +45 26472857
- Email: durita.videroe.gunnarsson@regionh.dk
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-
-
-
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Nuuk, Greenland
- Recruiting
- Queen Ingrids Hospital
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Contact:
- Sonja Sørensen, MSc., Physiotherapist
- Phone Number: +299 344741
- Email: sonj@peqqik.gl
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Admitted to one of the participating wards
- Has understood and signed informed consent
- Reads and understands Danish, Faroese, Greenlandic or English
Exclusion Criteria:
- Has an expected hospitalisation less than 24 hours after potential recruitment
- Is not able to give informed consent to participate in the study
- Has allergy towards band aid
- Not able to (shortly) stand in an upright position even with maximal assistance
- There are contraindications for the patient to mobilise or be physically active due to unstabilized acute medical conditions, including, but not limited to, acute aortic dissection, -myocardial infarction, -pulmonary embolism, -sepsis.
There are ethical concerns regarding the patients' participation in the study, including, but not limited to, the patient being:
- In the terminal phase of life
- In a crisis state regarding their disease/situation and deemed unfit for participation
To ensure medically responsible inclusion of patients, the project personnel will consult and confer with the treatment responsible medical doctor, or their delegate, before including a potential participant for the trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Control
Measurement of physical activity
|
Measurement of physical activity by accelerometer
|
|
Experimental: Intervention
Digital feedback and nudging to participant and staff regarding participants' physical activity levels
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Digital feedback and nudging to participants (patients) and staff, based on participants' physical activity measurements, aiming to increase patients' physical activity and reduce sedentary time
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Daily average time of participants' physical activity (minutes)
Time Frame: From enrollment to end of trial participation (maximum 7 days)
|
From enrollment to end of trial participation (maximum 7 days)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christian H Dall, Associate professor, PhD, Bispebjerg Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- VMK-2403916
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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