Vital Signs Monitoring in Rehabilitation Center Patients

It is Possible to Continuous Monitor Vital Signs in Patients Discharged a Rehabilitation Center - An Observational Feasibility Study

Some patients unable to return home from hospital due to physical or mental illness will be discharged to a rehabilitation home to restore strength and rehabilitate. This study attempts to examine if it is possible to continuously monitor the vital signs in patients discharged to a rehabilitation center and whether wearable devices will detect more abnormal vital signs than the rehabilitation facility, as well as complication and readmission rates.

Study Overview

• Status: Completed
• Conditions: Comorbidities

Detailed Description

Patients who are ready to leave the hospital but are deemed unable to return home are discharged to a rehabilitation center to regain strength and performance.

Vital signs are only measured when deemed necessary at the rehabilitation center, in contrast to hospital wards, where vital signs are measured intermittently and manually every 8-12 hours.

Wearable devices that continuously monitor a patient's vital signs may be able to detect patients who are deteriorating, as abnormal vital signs often precede a physiologic decline This study aims to determine whether it is possible to continuously monitor patients discharged to a rehabilitation center and detect more abnormal vital signs than measurements from the rehabilitation center. By attaching three wearable devices to 20 patients, we wished to record the vital signs for up to 96 hours, documenting abnormal vital signs as well as complications - and readmission rates.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Denmark
  • Brønshøj, Denmark, 2700
    • Center for Rehabilitering og Akutpleje - Bystævneparken

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hospital patients discharged to a rehabilitation center

Description

Inclusion Criteria:

• discharged to the rehabilitation center after surgery or; diagnosed with ischemic heart disease, chronic heart disease, apoplexia cerebri, chronic obstructive pulmonary disease, or diabetes.
• Inclusion less than 72 h from rehabilitation admission

Exclusion Criteria:

• Unable to give informed consent
• Implanted pacemaker or cardioverter-defibrillator
• allergic to plaster, plastic, silicone

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monitoring time	Monitoring time with data from any device	96 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SpO2 < 92%	Duration of SpO2 < 92%	96 hours
SpO2 < 88%	Duration of SpO2 < 88%	96 hours
SpO2 < 85%	Duration of SpO2 < 85%	96 hours
SpO2 < 80%	Duration of SpO2 < 80%	96 hours
Respiratory rate <5 breaths per minute	Duration of respiratory rate <5 breaths per minute	96 hours
Respiratory rate <11 breaths per minute	Duration of respiratory rate <11 breaths per minute	96 hours
Respiratory rate >24 breaths per minute	Duration of respiratory rate >24 breaths per minute	96 hours
Respiratory rate >30 breaths per minute	Duration of respiratory rate >30 breaths per minute	96 hours
Heart rate <30 beats per minute	Duration of heart rate <30 beats per minute	96 hours
Heart rate <40 beats per minute	Duration of heart rate <40 beats per minute	96 hours
Heart rate > 110 beats per minute	Duration of heart rate > 110 beats per minute	96 hours
Heart rate > 130 beats per minute	Duration of heart rate > 130 beats per minute	96 hours
Systolic blood pressure <70 mmHg	Number of systolic blood pressure <70 mmHg measurements	96 hours
Systolic blood pressure <90 mmHg	Number of systolic blood pressure <90 mmHg measurements	96 hours
Systolic blood pressure >180 mmHg	Number of systolic blood pressure >180 mmHg measurements	96 hours
Systolic blood pressure >220 mmHg	Number of systolic blood pressure >220 mmHg measurements	96 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication	Complication frequency within 30 days from study inclusion	30 days
Readmission	Readmission frequency within 30 days from study inclusion	30 days

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Eske K Aasvang, Dr. Med, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2019
• Primary Completion (Actual): September 8, 2021
• Study Completion (Actual): October 8, 2021

Study Registration Dates

• First Submitted: April 12, 2022
• First Submitted That Met QC Criteria: April 19, 2022
• First Posted (Actual): April 26, 2022

Study Record Updates

• Last Update Posted (Actual): May 13, 2022
• Last Update Submitted That Met QC Criteria: May 9, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Rehabilitation patients, wireless monitoring, vital signs
• Other Study ID Numbers: Rigshospitalet, Copenhagen

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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