Compromised patients or patients who are concerned about worsening as a result of infection.
Conditions
Interventions
Display of coping behavior alart from the app.
Sponsors
Nakao Hiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who visited to the site for emergency consultation during 1 year prior to enrollment, and required hospitalization for intensive care or for 30 days or more. Any of the following frequencies should be met: - Who visited the site several times for emergency consultation during 1 year prior to enrollment. - Who received emergency home-visit medical care several times during 1 year prior to enrollment. - Who asked medical institution or home-visit nursing station for medical advice several times during 1 year prior to enrollment. Or due to the severity of their primary diseases, patients who are judged by investigator to be likely to use medical resources like emergency hospitalization for intensive care or for 30 days or more, or emergency consultation during enrollment period. 2. Patients who, when recommended by the App, are able to contact a medical institution that uses the App promptly (approximately within 4 hours) after receiving the recommendation, or who are able to make an emergency visit to the hospital within 4 hours. 3. Parents and care provider who can use the app properly on a smartphone, including with the support of those around them. 4. Patients who can undergo examinations and observations according to the clinical trial schedule. 5. Patients who are judged by investigator to be appropriate to enroll in the clinical trial. 6. Parents who has been fully informed about participating in the clinical trial, and has given written consent of their own free will with a full understanding.
Exclusion criteria
Exclusion criteria: 1. Patients who are judged by investigator to be inappropriate for participating in the clinical trial. 2. Patients who are judged by investigator to be difficult on a timely manner to determine condition rated by the app basis of nature of the patients' disease etc. 3. Patients who are judged by investigator that participating the clinical trial would overburden parents and care provider. 4. Patients who are judged by investigator that parents and care provider are difficult to proper and continuously use of the app. 5. Patients who are participating in a clinical trial at a time giving informed consent, or received investigational product 3 months before giving informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Number of days of hospitalization (total number of days per patient) | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy endpoints: - Rate of ICU hospitalization (presence or absence of ICU hospitalization) - Number of times of ICU hospitalization (total number of times per patient) - Number of days of ICU hospitalization (total number of days per patient) - Rate of hospitalization (presence or absence of hospitalization) - Number of times of hospitalization (total number of times per patient) - PELOD-2 score - pSOFA score - QOL of parents (SF-8) - Anxiety and depression level of parents (HADS) - Number of times of unscheduled hospital visit - Time scale from recommendation alert appearing to visiting the site - Appropriateness of unscheduled hospital visit - Time scale of triage on unscheduled hospital visit - Time scale from coming to the site to start medical interventions Efficacy evaluative judgment: - Presence or absence of improvement compared to performance value (historical control value) Functionality endpoint: - Validity of recommendation score to consult with medical institution Safety endpoints: - Adverse events - Problems with the app | — |
Contacts
Public ContactHiro Nakao
National Center for Child Health and Development
Outcome results
None listed