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

21 Dec 2020

The date of last modification

Dec 22, 2020



Application Summary


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


Trial Details


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


Date of study completion


Recruitment status

Pending


Funding source

Hospital Adolfo Lopez Mateos, Institute of Social Security and Services for State Workers (ISSSTE), Mexico


Regulatory approvals



State of Ethics Review Approval


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 & Sponsor Information


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


Primary study sponsor/organization

Center for Research in Policies, Population and Health (CIPPS), of the Faculty of Medicine, National Autonomous University of Mexico (UNAM), Mexico





Secondary study sponsor (If any)







Trial Completion details


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