Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04423289 |
| Other study ID # |
PR(AG)182-2020 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 31, 2020 |
| Est. completion date |
May 18, 2020 |
Study information
| Verified date |
June 2020 |
| Source |
Hospital Universitari Vall d'Hebron Research Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Open-label randomized clinical trial, one center, to compare the need for face-to-face
re-consultation after discharge for COVID-19 between a telematic monitoring through a mobile
app and the regular primary care setting.
Description:
A randomized, open-label clinical trial, at one center, a 1100-bed academic hospital, Vall
d'Hebron Hospital Universitari, in Barcelona, Spain. Patients who met the enrolment criteria
were randomly assigned, in a 1:1 ratio, to be followed by the Farmalarm app or the primary
care setting.
Farmalarm is an app for smartphones designed to increase stroke awareness and treatment
compliance through visual and audible alerts. The application's software offers versatility
to modify the parameters to be monitored and the information to be sent, which were adapted
to our purpose.
Intervention was started after the patient was discharged and underwent randomization. At
this moment, patients assigned to the study group were given a personal access code ensuring
data privacy, and they were lent an intelligent pulse oximeter (SMART PULSE OXIMETER OL-750,
LifeVit, Guangdong Biolight Meditech CO., LTD, China). In a 15 minutes interview they were
trained in the use of the app, the use of the pulse oximeter and the measurement of some
vital signs.
On that same day, the healthcare professional uploaded and scheduled on the web-based
platform a personalized program for the following 2 weeks.
To maintain close control of respiratory evolution, patients registered at least 2 times a
day their heart rate, respiratory rate, temperature and peripheral capillary oxygen
saturation. The intelligent pulse oximeter allowed data to be downloaded directly to the WP
every time the patient used it. They also had to answer a symptom survey every day for the
same period. The WP allows scheduling alarms and so, in case one of the vital signs or survey
responses were altered, the healthcare in charge automatically received a notification, being
able to contact immediately the patient. A private chat between the patient and the
healthcare responsible for WP was attended every day from 8 AM to 5 PM to answer any doubt.
Patients assigned to control group received regular follow-up at the Primary Care, which used
phone calls to monitor patients' symptoms. Depending on the availability of human resources
of each Primary Care Centre and the care pressure of the moment, these phone calls were made
every 2 days, weekly, or just once during the whole follow-up period.
All patients were followed for two weeks. At the end of follow-up, all patients answered an
end-of-follow-up questionnaire and a Patient-Reported Outcomes Measurement Information System
(PROMIS) questionnaire about global health. The end-of-follow-up interview of experimental
group patients was carried by videoconference through the app. Control group patients were
telephonically contacted. All patients also answered a Hospital Anxiety and Depression Scale
(HADS) the same day of discharge and again at the end of follow-up. 12
