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IRCT20210509051231N1 IRCT 2021-06-23 Khalkhal university of medical sciences Evaluation of the effect of using COVID-19 mobile-based self-care application on patients with COVID-19 who do not need to be hospitalized Design, Implementation and Evaluation of a mobile-based education and self-care application for COVID-19 disease 2021-06-05 anticipated 70 Complete https://irct.ir/trial/56352 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: In this study, we evaluate a self-care mobile-based application in two groups of intervention and control. The content produced in this application is based on a review of texts and based on global guidelines in the field of Covid 19 disease. People in the study population are divided into two groups. In the intervention group, a self-care educational application is used for two to three weeks. In the control group, the treatment process continues routinely according to the training of comprehensive health centers, Randomization description: With simple randomization and using a random number table and individual randomization unit. To randomize, we use a table consisting of random digits 0 to 9. Each digit of this table is repeated the same on average. There is no pattern of recognizable numbers. In this method, each number is assigned to a treatment group. We start from the first line of the table and move down line by line. For the two treatments, we put the numbers 0 to 4 for treatment A and the numbers 5 to 9 for treatment B. The numbers in the first line of the table are as follows: 0,5,2,7,8,4,3,7,4,1,6,8,3,8,5,1,5,6,9,6, ... Now for people based on the above numbers, we have the following allocation: A, B, A, B, B,... We will continue the above process until the two groups are completed, Blinding description: Data analyzers will be blind in our study. N/A Covid19- Disease. Intervention 1: The fourth stage will be the clinical intervention and evaluation stage of software, in which the patients with Covid-19 who are required to self-quarantine at home and follow self-care protocols are divided into intervention and control groups. For the intervention group, the software will be installed on the smartphone and participants will be asked to use the software as a guide for compliance with health protocols, drug compliance, diet, exercise, and daily habits (smoking, sleep, and rest) for 4 weeks. After 4 weeks, the participants in both groups will be asked to complete a study checklist. The checklist has 3 parts. The first part includes demographic information of the participants in the study. The second part includes questions related to clinical symptoms of the disease (fever, body aches, cough, sore throat, gastrointestinal symptoms, and lack of smell and taste) as yes and no, duration of each symptom (as an open question) as well as total duration of the disease, with two yes and no questions on transmission to other family members and the number of people to whom the disease has spread. The third part includes phrases related to quarantine care protocols (health protocols, drug compliance, diet, exercise and daily habits (smoking, sleep and rest) in 3 options of I followed (score 3), I did not follow (score 2) and no case (score 1) that the participants will answer the questions according to their performance and finally the score of this part will be obtained. Since the present tool is a checklist, so investigating its validity and reliability is not necessary. Intervention 2: Control group: For the control group, routine care is provided by the University of Medical Sciences and software will be not provided to them. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I haven't decided yet - the release schedule is still unknown
public Mohammad Heydari
Shahid Mozaffar Azizi Street
Khalkhal Iran (Islamic Republic of) ۵۶۸۱۷۶۱۳۵۱ +98 45 3242 6601 heydari.mohammad12@yahoo.com Khalkhal university of medical sciences scientific Mohammad heydari
Shahid Mozaffar Azizi Street
Khalkhal Iran (Islamic Republic of) ۵۶۸۱۷۶۱۳۵۱ +98 45 3242 6601 heydari.mohammad12@yahoo.com Khalkhal university of medical sciences Iran (Islamic Republic of) Patients with COVID-19 who do not need to be hospitalized Having the skills to work with smart phones age range of 20 to 70 years 20 years 70 years Both unwilling to participate those that require hospitalization for worsening of their condition U07.1 COVID-19, virus identified Treatment - Devices Other The fourth stage will be the clinical intervention and evaluation stage of software, in which the patients with Covid-19 who are required to self-quarantine at home and follow self-care protocols are divided into intervention and control groups. For the intervention group, the software will be installed on the smartphone and participants will be asked to use the software as a guide for compliance with health protocols, drug compliance, diet, exercise, and daily habits (smoking, sleep, and rest) for 4 weeks. After 4 weeks, the participants in both groups will be asked to complete a study checklist. The checklist has 3 parts. The first part includes demographic information of the participants in the study. The second part includes questions related to clinical symptoms of the disease (fever, body aches, cough, sore throat, gastrointestinal symptoms, and lack of smell and taste) as yes and no, duration of each symptom (as an open question) as well as total duration of the disease, with two yes and no questions on transmission to other family members and the number of people to whom the disease has spread. The third part includes phrases related to quarantine care protocols (health protocols, drug compliance, diet, exercise and daily habits (smoking, sleep and rest) in 3 options of I followed (score 3), I did not follow (score 2) and no case (score 1) that the participants will answer the questions according to their performance and finally the score of this part will be obtained. Since the present tool is a checklist, so investigating its validity and reliability is not necessary. Control group: For the control group, routine care is provided by the University of Medical Sciences and software will be not provided to them. Duration of clinical symptoms and disease. Timepoint: at the baseline and 28 days after intervention. Method of measurement: Patient status checklist. Duration of recovery. Timepoint: at the baseline and 28 days after intervention. Method of measurement: Patient status checklist. Khalkhal university of medical sciences Approved 2020-11-18 Medical Ethics Committee of Khalkhal University of Medical Sciences Shahid Mozaffar Azizi Street Khalkhal Ardabil Iran (Islamic Republic of)