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General information
2020-04-26, 1399/02/07
2020-07-10, 1399/04/20
2020-0407-2610 00:00:00
2020-08-28, 1399/06/07
2021-03-18, 1399/12/28
20202021-0803-2818 00:00:00
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With the decrease in the number of patients with Covid-19 in Imam Reza hospital, the hospital was excluded from the coverage of corona-specific treatment. So, it was not possible to conduct the study. But with the increase in the number of patients in recent weeks, it was re-assigned to corona patients.
With the decrease in the number of patients with Covid-19 in Imam Reza hospital, the hospital was excluded from the coverage of corona-specific treatment. So, it was not possible to conduct the study. But with the increase in the number of patients in recent weeks, it was re-assigned to corona patients.
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با کاهش تعداد بیماران مبتلا به کرونا در بیمارستان امام رضا (ع)، این بیمارستان از پوشش درمان اختصاصی کرونا خارج شد و امکان انجام مطالعه وجود نداشت. اما با افزایش تعداد مبتلایان در هفته‌های اخیر دوباره به بیماران کرونایی اختصاص یافت.
با کاهش تعداد بیماران مبتلا به کرونا در بیمارستان امام رضا (ع)، این بیمارستان از پوشش درمان اختصاصی کرونا خارج شد و امکان انجام مطالعه وجود نداشت. اما با افزایش تعداد مبتلایان در هفته‌های اخیر دوباره به بیماران کرونایی اختصاص یافت.
Recruitment centers
#1
Name of recruitment center - English: Emam Reza Hospital
Name of recruitment center - Persian: بیمارستان امام رضا
Full name of responsible person - English: Dr. Mahnaz Amini
Full name of responsible person - Persian: دکتر مهناز امینی
Street address - English: Emam Reza Square, Ebne Sina Avenue, Mashhad, Iran
Street address - Persian: مشهد، خیابان ابن سینا، میدان امام رضا
City - English: mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9176644889
Phone: +98 51 3882 7049
Fax:
Email: aalaeish@mums.ac.ir
Web page address:
Name of recruitment center - English: Emam Reza Hospital
Name of recruitment center - Persian: بیمارستان امام رضا
Full name of responsible person - English: Dr. Mahnaz Amini
Full name of responsible person - Persian: دکتر مهناز امینی
Street address - English: Emam Reza square, Ebne Sina avenue
Street address - Persian: خیابان ابن سینا، میدان امام رضا
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9176644889
Phone: +98 51 3882 7049
Fax:
Email: aalaeish@mums.ac.ir
Web page address:
Name of recruitment center - English: Emam Reza Hospital Name of recruitment center - Persian: بیمارستان امام رضا Full name of responsible person - English: Dr. Mahnaz Amini Full name of responsible person - Persian: دکتر مهناز امینی Street address - English: Emam Reza Squaresquare, Ebne Sina Avenue, Mashhad, Iranavenue Street address - Persian: مشهد، خیابان ابن سینا، میدان امام رضا City - English: mashhadMashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9176644889 Phone: +98 51 3882 7049 Fax: Email: aalaeish@mums.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Tafaghodi Mohsen
Full name of responsible person - Persian: دکتر محسن تفقدی
Street address - English: azadi square mashhad iran
Street address - Persian: میدان آزادی، مشهد، ایران
City - English: mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9176644889
Phone: +98 51 3882 7049
Fax:
Email: TafaghodiM@mums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr.Mohsen Tafaghodi
Full name of responsible person - Persian: دکتر محسن تفقدی
Street address - English: Azadi square
Street address - Persian: میدان آزادی
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9176644889
Phone: +98 51 3882 7049
Fax:
Email: TafaghodiM@mums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr.Dr.Mohsen Tafaghodi Mohsen Full name of responsible person - Persian: دکتر محسن تفقدی Street address - English: azadiAzadi square mashhad iran Street address - Persian: میدان آزادی، مشهد، ایران City - English: mashhadMashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9176644889 Phone: +98 51 3882 7049 Fax: Email: TafaghodiM@mums.ac.ir Web page address:
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: aalaei shokoufeh
Full name of responsible person - Persian: شکوفه اعلایی
Position - English: Assistant Professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 9
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: azadi square mashhad iran
Street address - Persian: ایران، مشهد، میدان آزادی
City - English: mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 9176644889
Phone: +98 51 3882 7049
Mobile: +98 915 542 4856
Fax:
Email: aalaeish@mums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Aalaei Shokoufeh
Full name of responsible person - Persian: شکوفه اعلایی
Position - English: Assistant Professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 9
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Azadi square
Street address - Persian: میدان آزادی
City - English: Mashhad
City - Persian: Mashhad
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 917-7948-564
Phone: +98 51 3882 7049
Mobile: +98 915 542 4856
Fax:
Email: aalaeish@mums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: aalaei shokoufehAalaei Shokoufeh Full name of responsible person - Persian: شکوفه اعلایی Position - English: Assistant Professor Position - Persian: استادیار Latest degree: phd Area of specialty/work: 9 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: azadiAzadi square mashhad iran Street address - Persian: ایران، مشهد، میدان آزادی City - English: mashhadMashhad City - Persian: مشهدMashhad Province: Razavi Khorasan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 9176644889917-7948-564 Phone: +98 51 3882 7049 Mobile: +98 915 542 4856 Fax: Email: aalaeish@mums.ac.ir Web page address:
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: aalaei shokoufeh
Full name of responsible person - Persian: شکوفه اعلایی
Position - English: assistant professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 9
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: azadi square mashhad iran
Street address - Persian: مشهد، میدان آزادی
City - English: mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 9176644889
Phone: +98 51 3882 7049
Mobile: +98 915 542 4856
Fax:
Email: aalaeish@mums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Aalaei Shokoufeh
Full name of responsible person - Persian: شکوفه اعلایی
Position - English: Assistant Professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 9
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Azadi square
Street address - Persian: میدان آزادی
City - English: Mashhad
City - Persian: Mashhad
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 917-7948-564
Phone: +98 51 3882 7049
Mobile: +98 915 542 4856
Fax:
Email: aalaeish@mums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: aalaei shokoufehAalaei Shokoufeh Full name of responsible person - Persian: شکوفه اعلایی Position - English: assistant professorAssistant Professor Position - Persian: استادیار Latest degree: phd Area of specialty/work: 9 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: azadiAzadi square mashhad iran Street address - Persian: مشهد، میدان آزادی City - English: mashhadMashhad City - Persian: مشهدMashhad Province: Razavi Khorasan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 9176644889917-7948-564 Phone: +98 51 3882 7049 Mobile: +98 915 542 4856 Fax: Email: aalaeish@mums.ac.ir Web page address:
Protocol summary
Study aim
The effect of self-care mobile-based intervention on psychologic parameters of admitted patients with COVID-19
Design
A randomized, nonblinded, two-arm, parallel-group, phase 3 controlled trial on 112 patients.
www.randomization.com website was used for randomization.
Settings and conduct
This study will be conducted on 112 patients admitted to Imam Reza hospital in Mashhad who diagnosed with COVID-19
Participants/Inclusion and exclusion criteria
Inclusion criteria: Hospitalized patients with COVID- 19; patients who own a smartphone; patients who have the ability to work with a smartphone; at least 18 years old.
Exclusion criteria: Unwillingness to stay in the study; Transfer to wards where it is not possible to use a cellphone, such as the intensive care unit.
Intervention groups
This study consists of two groups. In addition to usual care, patients in the intervention group will receive a self-care smartphone application provided with the capability to educate patients, establish two-way interaction between patients and their attending physician, and psychological consultants. Patients in the control group will only receive usual care.
Main outcome variables
DASS-21 questionnaire score
General information
Reason for update
With the decrease in the number of patients with Covid-19 in Imam Reza hospital, the hospital was excluded from the coverage of corona-specific treatment. So, it was not possible to conduct the study. But with the increase in the number of patients in recent weeks, it was re-assigned to corona patients.
Acronym
IRCT registration information
IRCT registration number:IRCT20170922036314N4
Registration date:2020-06-22, 1399/04/02
Registration timing:prospective
Last update:2020-08-08, 1399/05/18
Update count:1
Registration date
2020-06-22, 1399/04/02
Registrant information
Name
Shokoufeh Aalaei
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2429
Email address
aalaeish931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-10, 1399/04/20
Expected recruitment end date
2021-03-18, 1399/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effects of self-care mobile application on psychologic parameters of admitted patients with Covid-19: a randomized controlled trial
Public title
The effects of self-care cellphone application on stress, anxiety and depression among admitted patients with COVID-19
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
baseline literacy
having a smartphone
ability to work with smartphone
at least 3 days hospitalization
Exclusion criteria:
Unwillingness to participate in the study
Transfer to wards where it is not possible to use a mobile phone, such as the intensive care unit
Deterioration of the patient's physical condition
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization: simple randomization; Unit of randomization: individual randomization; the tool used in randomization: sealed envelops; the random sequence will be built using www.randomization.com website
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee; Mashhad University of Medical Sciences
Street address
Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9176644889
Approval date
2020-04-19, 1399/01/31
Ethics committee reference number
IR.MUMS.REC.1399.118
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07. 1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
DASS‐21 questionnaire score
Timepoint
Before intervention, at the time of discharge, 2 weeks after discharge
Intervention group: The intervention group will use a mobile-based application from the time of admission to two weeks after discharge. Educational material in the application required for patients with COVID-19 is provided using valid educational resources and experts' consensus. Also, patients can ask their questions from care providers through application and receive appropriate answers. Also, the patients can record their symptoms and thus their physician will be able to monitor and control their illness remotely.
Category
Behavior
2
Description
Control group: The control group will not receive intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Dr. Mahnaz Amini
Street address
Emam Reza square, Ebne Sina avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9176644889
Phone
+98 51 3882 7049
Email
aalaeish@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Mohsen Tafaghodi
Street address
Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9176644889
Phone
+98 51 3882 7049
Email
TafaghodiM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Aalaei Shokoufeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Informatics
Street address
Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
917-7948-564
Phone
+98 51 3882 7049
Email
aalaeish@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Aalaei Shokoufeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Informatics
Street address
Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
917-7948-564
Phone
+98 51 3882 7049
Email
aalaeish@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shokoufeh Aalaei
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Informatics
Street address
Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9176644889
Phone
+98 51 3882 7049
Email
aalaeish@mums.ac.ir
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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available