NCT05345626

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 14, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 26, 2022

Completed
Last Updated

May 13, 2022

Status Verified

May 1, 2022

Enrollment Period

1.9 years

First QC Date

April 12, 2022

Last Update Submit

May 9, 2022

Conditions

Comorbidities

Keywords

Rehabilitation patients, wireless monitoring, vital signs

Outcome Measures

Primary Outcomes (1)

  • Monitoring time

    Monitoring time with data from any device

    96 hours

Secondary Outcomes (16)

  • SpO2 < 92%

    96 hours

  • SpO2 < 88%

    96 hours

  • SpO2 < 85%

    96 hours

  • SpO2 < 80%

    96 hours

  • Respiratory rate <5 breaths per minute

    96 hours

  • +11 more secondary outcomes

Other Outcomes (2)

  • Complication

    30 days

  • Readmission

    30 days

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospital patients discharged to a rehabilitation center

You may qualify if:

  • discharged to the rehabilitation center after surgery or; diagnosed with ischemic heart disease, chronic heart disease, apoplexia cerebri, chronic obstructive pulmonary disease, or diabetes.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Rehabilitering og Akutpleje - Bystævneparken

Brønshøj, 2700, Denmark

Location

Study Officials

  • Eske K Aasvang, Dr. Med

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 12, 2022

First Posted

April 26, 2022

Study Start

October 14, 2019

Primary Completion

September 8, 2021

Study Completion

October 8, 2021

Last Updated

May 13, 2022

Record last verified: 2022-05

Locations

DK(1)