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Design, Implementation and Evaluation of a mobile-based education and self-care application for COVID-19 disease

Protocol summary

Study aim
Design, Implementation and Evaluation of a mobile-based education and self-care application for COVID-19 disease
Design
The study will be in two groups, with a sample size of 70 based on similar studies. Simple randomization was performed in this study. And this is a one-way blind study. The random number table method is also used for randomization.
Settings and conduct
Khalkhal University of medical sciences
Participants/Inclusion and exclusion criteria
Patients with COVID-19 who do not need to be hospitalized. Having the skills to work with smartphones
Intervention groups
The intervention group receives a mobile-based self-care educational application. The control group will not have technology-based intervention and receive the routine training of health centers.
Main outcome variables
Improving patients' knowledge in the field of self-care and better disease management. Reduce the duration of disease recovery by monitoring and controlling the treatment process. Involve the patient in the care and treatment of the disease.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210509051231N1
Registration date: 2021-06-23, 1400/04/02
Registration timing: registered_while_recruiting

Last update: 2021-06-23, 1400/04/02
Update count: 0
Registration date
2021-06-23, 1400/04/02
Registrant information
Name
Mohammad Heydari
Name of organization / entity
Khalkhal University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3242 6606
Email address
heydari.mohammad12@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-05, 1400/03/15
Expected recruitment end date
2021-07-05, 1400/04/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design, Implementation and Evaluation of a mobile-based education and self-care application for COVID-19 disease
Public title
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
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
unwilling to participate those that require hospitalization for worsening of their condition
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
Blinding description
Data analyzers will be blind in our study.
Placebo
Not used
Assignment
Parallel
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.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Medical Ethics Committee of Khalkhal University of Medical Sciences
Street address
Shahid Mozaffar Azizi Street
City
Khalkhal
Province
Ardabil
Postal code
۵۶۸۱۷۶۱۳۵۱
Approval date
2020-11-18, 1399/08/28
Ethics committee reference number
IR.KHALUMS.REC.1399.010

Health conditions studied

1

Description of health condition studied
Covid19- Disease
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified

Primary outcomes

1

Description
Duration of clinical symptoms and disease
Timepoint
at the baseline and 28 days after intervention
Method of measurement
Patient status checklist

2

Description
Duration of recovery
Timepoint
at the baseline and 28 days after intervention
Method of measurement
Patient status checklist

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Treatment - Devices

2

Description
Control group: For the control group, routine care is provided by the University of Medical Sciences and software will be not provided to them.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Medical centers of Khalkhal city
Full name of responsible person
Mohammad Heydari
Street address
Shahid Mozaffar Azizi Street
City
Ardabil -Khalkhal
Province
Ardabil
Postal code
۵۶۸۱۷۶۱۳۵۱
Phone
+98 45 3242 6601
Email
heydari.mohammad12@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khalkhal university of medical sciences
Full name of responsible person
Esmaeel Mehraeen
Street address
Shahid Mozaffar Azizi Street
City
Khalkhal
Province
Ardabil
Postal code
۵۶۸۱۷۶۱۳۵۱
Phone
+98 45 3242 6601
Email
es.mehraeen@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khalkhal university of medical sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Khalkhal university of medical sciences
Full name of responsible person
Mohammad Heydari
Position
Faculty member- instructor
Latest degree
Master
Other areas of specialty/work
Health Technology Assessment
Street address
Shahid Mozaffar Azizi Street
City
Khalkhal
Province
Ardabil
Postal code
۵۶۸۱۷۶۱۳۵۱
Phone
+98 45 3242 6601
Email
heydari.mohammad12@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Khalkhal university of medical sciences
Full name of responsible person
Mohammad heydari
Position
Faulty member-instructor
Latest degree
Master
Other areas of specialty/work
Health Technology Assessment
Street address
Shahid Mozaffar Azizi Street
City
Khalkhal
Province
Ardabil
Postal code
۵۶۸۱۷۶۱۳۵۱
Phone
+98 45 3242 6601
Email
heydari.mohammad12@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Khalkhal university of medical sciences
Full name of responsible person
Mohammadi Heydari
Position
Faculty member-instructor
Latest degree
Master
Other areas of specialty/work
Health Technology Assessment
Street address
Shahid Mozaffar Azizi Street
City
Khalkhal
Province
Ardabil
Postal code
۵۶۸۱۷۶۱۳۵۱
Phone
+98 45 3242 6601
Email
heydari.mohammad12@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
I haven't decided yet - the release schedule is still unknown
When the data will become available and for how long
I haven't decided yet - the release schedule is still unknown
To whom data/document is available
I haven't decided yet - the release schedule is still unknown
Under which criteria data/document could be used
I haven't decided yet - the release schedule is still unknown
From where data/document is obtainable
I haven't decided yet - the release schedule is still unknown
What processes are involved for a request to access data/document
I haven't decided yet - the release schedule is still unknown
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