Vital Signs Monitoring in Rehabilitation Center Patients

Completed

• Conditions: Comorbidities

• Registration Number: NCT05345626
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

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.

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 Timeline

• Study Start: 2019-10-14
• Primary Completion: 2021-09-08
• Study Completion: 2021-10-08
• Study First Submitted: 2022-04-12
• Study First Submitted QC: 2022-04-19
• Study First Posted: 2022-04-26
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-09
• Last Update Posted: 2022-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Monitoring time	96 hours	Monitoring time with data from any device

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Center for Rehabilitering og Akutpleje - Bystævneparken; 🇩🇰 Brønshøj, Denmark