ComorbiditiesNCT05345626
Vital Signs Monitoring in Rehabilitation Center Patients
An observational study of Comorbidities, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Comorbidities
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 14 Oct 2019to 8 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospital patients discharged to a rehabilitation center
Who may be able to join
- discharged to the rehabilitation center after surgery or; diagnosed with ischemic heart disease, chronic heart disease, apoplexia cerebri, chronic obstructive pulmonary disease, or diabetes.
Who cannot join
- Unable to give informed consent
- Implanted pacemaker or cardioverter-defibrillator
- allergic to plaster, plastic, silicone
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Rehabilitering og Akutpleje - Bystævneparken
Brønshøj, 2700
About this study
Official title: 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.
Read the 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.
- Conditions
- Comorbidities
- Keywords
- Rehabilitation patients, wireless monitoring, vital signs
What is being measured
The primary outcome is the main question the study is designed to answer.
Monitoring time
Monitoring time with data from any device
Measured: 96 hours
Secondary outcomes (16)
SpO2 < 92%
Duration of SpO2 < 92%
Measured: 96 hours
SpO2 < 88%
Duration of SpO2 < 88%
Measured: 96 hours
SpO2 < 85%
Duration of SpO2 < 85%
Measured: 96 hours
SpO2 < 80%
Duration of SpO2 < 80%
Measured: 96 hours
Respiratory rate <5 breaths per minute
Duration of respiratory rate <5 breaths per minute
Measured: 96 hours
Respiratory rate <11 breaths per minute
Duration of respiratory rate <11 breaths per minute
Measured: 96 hours
Respiratory rate >24 breaths per minute
Duration of respiratory rate >24 breaths per minute
Measured: 96 hours
Respiratory rate >30 breaths per minute
Duration of respiratory rate >30 breaths per minute
Measured: 96 hours
Heart rate <30 beats per minute
Duration of heart rate <30 beats per minute
Measured: 96 hours
Heart rate <40 beats per minute
Duration of heart rate <40 beats per minute
Measured: 96 hours
Heart rate > 110 beats per minute
Duration of heart rate > 110 beats per minute
Measured: 96 hours
Heart rate > 130 beats per minute
Duration of heart rate > 130 beats per minute
Measured: 96 hours
Systolic blood pressure <70 mmHg
Number of systolic blood pressure <70 mmHg measurements
Measured: 96 hours
Systolic blood pressure <90 mmHg
Number of systolic blood pressure <90 mmHg measurements
Measured: 96 hours
Systolic blood pressure >180 mmHg
Number of systolic blood pressure >180 mmHg measurements
Measured: 96 hours
Systolic blood pressure >220 mmHg
Number of systolic blood pressure >220 mmHg measurements
Measured: 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start14 Oct 2019
- Primary completion8 Sep 2021
- Study completion8 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ComorbiditiesStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eske Kvanner Aasvang, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Eske K Aasvang, Dr. Med, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345626
- Sponsor's protocol ID
- Rigshospitalet, Copenhagen
- Status last verified
- May 2022
- First submitted
- 12 Apr 2022
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- It is Possible to Continuous Monitor Vital Signs in Patients Discharged a Rehabilitation Center - An Observational Feasibility Study
- ClinicalTrials.gov ID
- NCT05345626
- Acronym / sponsor ID
- Rigshospitalet, Copenhagen
- Conditions
- Comorbidities
- Keywords
- Rehabilitation patients, wireless monitoring, vital signs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 8 Sep 2021 (actual)
- Study completion
- 8 Oct 2021 (actual)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital patients discharged to a rehabilitation center
Key inclusion criteria (1 listed)
- discharged to the rehabilitation center after surgery or; diagnosed with ischemic heart disease, chronic heart disease, apoplexia cerebri, chronic obstructive pulmonary disease, or diabetes.
Key exclusion criteria (3 listed)
- Unable to give informed consent
- Implanted pacemaker or cardioverter-defibrillator
- allergic to plaster, plastic, silicone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Monitoring time
Time frame: 96 hours
Monitoring time with data from any device
16 secondary outcomes
SpO2 < 92%
Time frame: 96 hours
SpO2 < 88%
Time frame: 96 hours
SpO2 < 85%
Time frame: 96 hours
SpO2 < 80%
Time frame: 96 hours
Respiratory rate <5 breaths per minute
Time frame: 96 hours
Respiratory rate <11 breaths per minute
Time frame: 96 hours
Respiratory rate >24 breaths per minute
Time frame: 96 hours
Respiratory rate >30 breaths per minute
Time frame: 96 hours
Heart rate <30 beats per minute
Time frame: 96 hours
Heart rate <40 beats per minute
Time frame: 96 hours
Heart rate > 110 beats per minute
Time frame: 96 hours
Heart rate > 130 beats per minute
Time frame: 96 hours
Systolic blood pressure <70 mmHg
Time frame: 96 hours
Systolic blood pressure <90 mmHg
Time frame: 96 hours
Systolic blood pressure >180 mmHg
Time frame: 96 hours
Systolic blood pressure >220 mmHg
Time frame: 96 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Comorbidities
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Active, not recruitingObservational study
Association of POCD With Circulating Biomarkers in Patients Undergoing TUR of Bladder Tumor
Cognitive Decline, Urinary Bladder Cancer
RecruitingPhase 3
A Study of Orforglipron (LY3502970) in Adolescent Participants With Obesity, or Overweight With Related Comorbidities
Obesity, Overweight
Enrolling by invitationObservational study
Comorbidity, Cognition, Gait Speed, and Respiratory Muscle Strength in Older Adults
Geriatrics, Older Adults (60 - 85 Years Old)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eske K Aasvang, Dr. Med principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Comorbidities, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monitoring time (time frame: 96 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2022.