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Investigating the effect of using the mobile health program in communities on reducing the incidence of seasonal diseases

Protocol summary

Study aim
Investigating the effect of using the mobile health program in communities on reducing the incidence of seasonal diseases
Design
The study will be conducted as a clinical trial with a control group, with parallel groups, one-sided blind, with the participation of 80 patients hospitalized due to trauma. Randomization will be done using white and black colored cards.
Settings and conduct
People participating in the mass gatherings, if they are eligible, will be included in the study and will be randomly assigned to two intervention and control groups using colored cards. This study will be performed in a blind way. In this way, researcher A will do the evaluation and error checking will be done by researcher B, who will be unaware of the allocation of groups. Also, the data analyst will not know about the grouping of the participants.
Participants/Inclusion and exclusion criteria
The condition for entering the study is hospitalization due to trauma, and the condition for not entering is not having a smart phone and not wanting to use a mobile app.
Intervention groups
In the intervention group, using health software in the prepared communities, they are taught about common seasonal diseases such as influenza, covid, heatstroke, etc., and their ability to identify early symptoms and self-care is improved. In the control group, regular training is given using pamphlets.
Main outcome variables
Reducing the incidence of seasonal diseases such as flu, heat stroke, etc.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210131050189N8
Registration date: 2023-12-29, 1402/10/08
Registration timing: registered_while_recruiting

Last update: 2023-12-29, 1402/10/08
Update count: 0
Registration date
2023-12-29, 1402/10/08
Registrant information
Name
Raziyeh Ghafouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3335 4520
Email address
ghafouri@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-21, 1402/09/30
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of using the mobile health program in communities on reducing the incidence of seasonal diseases
Public title
The effect of the mobile health program in communities on reducing the incidence of seasonal diseases
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having a smart phone Hospitalized due to trauma
Exclusion criteria:
Reluctance to use mobile application for initial assessment after hospitalization
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Before starting the research, 40 white color cards and 40 black cards will be prepared. All the cards will be placed in an envelope, then the cards will be taken out randomly and numbered from 1 to 80 in order of exit. Each card will then be placed in a sealed envelope and its number will be written on the envelope. As each patient enters the study, a special envelope from number 1 to 80 will be opened for him. If the card is white, the participant will be assigned to the intervention group, and if the card is black, the participant will be assigned to the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The evaluation of patients is done by researcher A, and the evaluation of the incidence of seasonal diseases (heatstroke, flu) is checked by researcher B. Also, the data analyst will not know the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Shahid Beheshti University of Medical Sciences
Street address
Shahid Arabi Street, Yemen Street, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-10-09, 1402/07/17
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1402.109

Health conditions studied

1

Description of health condition studied
Heat stroke
ICD-10 code
T67.0
ICD-10 code description
Heatstroke and sunstroke

2

Description of health condition studied
Influenza
ICD-10 code
J10
ICD-10 code description
Influenza due to other identified influenza virus

Primary outcomes

1

Description
Getting heatstroke
Timepoint
One month after using the program
Method of measurement
Occurrence of heatstroke symptoms: dizziness, pressure drop and heart palpitations in hot environments

2

Description
Getting the flu
Timepoint
One month after using the program
Method of measurement
Influenza symptoms: fever, weakness, lethargy and fatigue

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, using health software in the prepared communities, they are taught about common seasonal diseases such as influenza, covid, heatstroke, etc., and their ability to identify early symptoms and self-care in prevention of common seasonal diseases is improved.
Category
Prevention

2

Description
Control group: In the control group, regular training is given using pamphlets.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein Hospital, Tehran
Full name of responsible person
Raziyeh Ghafouri
Street address
Shahid Madani Street, Imam Hossein Square, Tehran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 3000
Email
info@sbmu.ac.ir

2

Recruitment center
Name of recruitment center
(Ayatollah) Taleghani Educational Hospital
Full name of responsible person
Raziyeh Ghafouri
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2303 1100
Email
taleghani@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zergi
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Email
Intl_office@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Raziyeh Ghafouri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
SBMU School of Nursing & Midwifery, Vali-Asr Avenue, Cross of Vali-Asr Avenue and Hashemi Rafsanjani (Neiaiesh) Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+9888202520
Email
raziehghafouri@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Raziyeh ghafouri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
SBMU School of Nursing & Midwifery, Vali-Asr Avenue, Cross of Vali-Asr Avenue and Hashemi Rafsanjani (Neiaiesh) Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8820 2520
Email
raziehghafouri@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Raziyeh Ghafouri
Position
َAssistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
SBMU School of Nursing & Midwifery, Vali-Asr Avenue, Cross of Vali-Asr Avenue and Hashemi Rafsanjani (Neiaiesh) Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
0982188202520
Email
raziehghafouri@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
By email to the corresponding author raziehghafouri@gmail.com
When the data will become available and for how long
After the publication of the article
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
More research
From where data/document is obtainable
By email to the corresponding author raziehghafouri@gmail.com
What processes are involved for a request to access data/document
By email to the corresponding author raziehghafouri@gmail.com
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