Home » Trials » SLCTR/2020/026
Effects on the clinical evolution of patients hospitalized for respiratory infection secondary to the Sars-CoV-2 virus, when they are maintaining communication with their families through mobile devices
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SLCTR Registration Number
SLCTR/2020/026
Date of Registration
The date of last modification
Aug 31, 2021
Trial Status
Scientific Title of Trial
Effects on the clinical evolution of patients hospitalized for respiratory infection secondary to the Sars-CoV-2 virus, when they are maintaining communication with their families through mobile devices
Public Title of Trial
Effects on the clinical evolution of patients with respiratory infection secondary to the Sars-CoV-2 virus, when they are maintaining communication with family/friends through mobile devices compared to patients not having an option of communication
Disease or Health Condition(s) Studied
COVID-19
Scientific Acronym
Effects of communication with their families through mobile devices on COVID-19
Public Acronym
None
Brief title
Effects of communication with their families/friends through mobile devices on patients with respiratory infection secondary to Sars-CoV-2 virus
Universal Trial Number
U1111-1259-9918
Any other number(s) assigned to the trial and issuing authority
FM/DI/084/2020
What is the research question being addressed?
What is the effect of mobile communication compared to no communication on the clinical evolution of patients hospitalized for respiratory infection secondary to the Sars-CoV-2 virus?
Type of study
Interventional
Study design
Allocation
Non-randomized controlled trial
Masking
Single blinded : Data analysts
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Health services research
Study Phase
Not Applicable
Intervention(s) planned
The study will be carried out in the Covid-19 hospitalization area. Patients will be assigned to Groups 1 or 2 alternately, according to the availability of beds. Group 2 patients (Control) will not have any type of communication with family or friends. Hospital regulations do not allow it. Video calls that will be allowed to Group 1(Intervention group) will be made by a medical researcher from this team, with a mobile device owned by the hospital and communication will be made with the person of the patient's preference, for a maximum of 5 minutes. The duration of the intervention will be throughout the hospitalization for both groups.
Inclusion criteria
• Men and women • Older than 18 years • Patients with lung infection by the Sars-Cov-2 virus (Covid-19) • With O2 saturation greater than 70% and less than 89% upon admission to the emergency room • Have family or friends to call • The family member or friends have a mobile device to receive video calls
Exclusion criteria
Intubated or with respiratory failure that prevents them from participating • Alterations in the state of consciousness. • Intellectual, verbal, hearing disability • Previous psychiatric or mental disorders (anxiety, depression, bipolar, dementia, etc.) • Voluntary discharge
Primary outcome(s)
|
1.
The average number of days of confinement |
[ Measured during the hospital stay up to discharge ] |
|
2.
Types of complications occurred during the hospital stay |
[ Measured at discharge of patient ] |
|
3.
Outcome of the disease |
[ Measured at discharge of patient ] |
Secondary outcome(s)
|
1.
The total cost of bed days will be measured + cost of drugs used + cost of laboratory and cabinet tests = Total Cost, for each of the groups |
[ Measured at hospital discharge of patient ] |
Target number/sample size
386 (193 in a group)
Countries of recruitment
American Samoa
Anticipated start date
2020-12-22
Anticipated end date
2021-03-15
Date of first enrollment
2020-12-22
Date of study completion
Recruitment status
Suspended
Funding source
Hospital Adolfo Lopez Mateos, Institute of Social Security and Services for State Workers (ISSSTE), Mexico
Regulatory approvals
Status
Approved
Date of Approval
2020-10-06
Approval number
FM/DI/084/2020
Details of Ethics Review Committee
| Name: | Comite de Etica de la División de Investigación UNAM |
| Institutional Address: | Facultad de Medicina, Ciudad Universitaria, Coyoacan. CP. 04510. Ciudad de México, Mexico |
| Telephone: | 0052 5555 23 2401 |
| Email: | ciefm@unam.mx |
Contact person for Scientific Queries/Principal Investigator
Miguel Angel Fernández Ortega
Researcher from the Center for Research on Population and Health Policies (CIPPS)
Cultural zone s / n. Building C-3 / CIPPS 2nd floor Ciudad Universitaria, Coyoacan Ciudad de México, CP 04510
0052 5556 22 1599
0052 1 55 4448 6384
miguelaf03@live.com
Contact Person for Public Queries
Miguel Angel Fernández Ortega
Researcher from the Center for Research on Population and Health Policies (CIPPS)
Cultural zone s / n. Building C-3 / CIPPS 2nd floor Ciudad Universitaria, Coyoacan Ciudad de México, CP 04510
0052 5556 22 1599
0052 1 55 4448 6384
miguelaf03@live.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
Individual participant data will be available on request from the authors Data in a particular field will be available on request from the authors Analyses available on request from the authors
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
