The effect of educational software application based on mobile base learning on blood pressure and quality of life of military men with hypertension
Design
Randomized clinical trial.The sample size of the control and intervention groups is Thirty-three people.In this study, the samples were first sampled Simple random sampling method.They will then be randomly assigned to two groups of intervention and control.
Settings and conduct
The sampling site is a martyr Heart Hospital. After selecting the samples, they will be considered if they are willing to participate in the research. First, the demographic information form and then the health-related quality of life questionnaire (SF-36) will be completed by eligible applicants. Blood pressure before the start of the study will be measured and recorded from the two groups in the designed checklist. Six weeks after installing the software will be reviewed and compared
Participants/Inclusion and exclusion criteria
Entry criteria : Diagnosis of blood pressure by the doctor
ages 35 to 55 years ، Mobile access and ability to use it
Exit criteria :Unwillingness to participate in the study
Intervention groups
the intervention group: six weeks have been used and their pressure on the quality of their life is compared to both before and the control unit is compared.
control group: During clearance, they receive only hospital training that they do not receive, and then their pressure on their life is compared to pre - study and with the intervention group's people.
Main outcome variables
blood pressure
quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190626044026N1
Registration date:2019-12-14, 1398/09/23
Registration timing:retrospective
Last update:2019-12-14, 1398/09/23
Update count:0
Registration date
2019-12-14, 1398/09/23
Registrant information
Name
Fereshteh Falah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3342 1427
Email address
falahfereshteh407@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2019-08-24, 1398/06/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational software application based on mobile base learning on blood pressure and quality of life of military men with hypertension
Public title
The effect of educational software application based on mobile base learning on blood pressure and quality of life of military men with hypertension
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of blood pressure by the physician
Excellent 35-55 years
No occupation of the patient or family member in the medical staff
No admission to different parts of the hospital after completion of treatment
Lack of hearing impairment, vision
Minimum reading and writing comprehension
Access to the mobile phone and the ability to use it
The ability to install a mobile phone app
Exclusion criteria:
Unwillingness to participate in the study
Age
From 35 years old to 55 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the samples were first selected easily among militants with hypertension (based on the approval of an internal medicine specialist) who have criteria for entering the research and then assigned randomly into two groups of test and control. In this way, envelopes containing cards with A and C adhesives will be requested and the military personnel will be required to randomly select one of the envelopes, those who will receive the A card, in the test group and those who have the card C will be assigned to the control group. Thus sampling will continue until the sample size is determined, the researcher will consider the dropping of samples according to the specified exit rates.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The study is a randomized clinical trial. We will have two intervention and control groups. The intervention group received the app in addition to the hospital training but the control group received only the hospital training.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of aja University of Medical Sciences
Street address
Sadi Alley; Karim khan Ave;
City
Khoramabad
Province
Lorestan
Postal code
6819755836
Approval date
2019-07-30, 1398/05/08
Ethics committee reference number
IR.AJAUMS.REC.1398.041
Health conditions studied
1
Description of health condition studied
blood pressure
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
blood pressure
Timepoint
Pressure measurement before and 6 weeks after the study
Method of measurement
Mercury barometer
Secondary outcomes
1
Description
life quality
Timepoint
Before the study and 6 weeks after the study
Method of measurement
Sf-36 questionnaire
Intervention groups
1
Description
"Intervention group: "in the first step, the researcher will collect and compile content based on the library studies and the Global Guide to the Management and Treatment of Blood Pressure and Search in Valid Databases and Scientific Articles by the Researcher in order to gather the contents for the desired software. Various hypertension topics include caring topics including nutrition, exercise, diet and medication, risk factors, which are technically and scientifically approved by the Faculty of Nursing of the Army University, Internal and Cardiovascular Specialists, Shahid Medical Center Health Education Committee. Civil will arrive in Khorramabad city The capabilities of the educational software of interest to the researcher will be presented to the programming engineer and according to those features the appropriate software will be designed by the programming engineer. The software will be Android-based and will be designed to be used offline. The software will be installed on the intervention group's smartphone and the researcher will be given a lecture and practical information in a 60-minute session of the software's features and how to use it in coordination with the hospital training supervisor in the training center conference hall. They will be. Also, at the end of the training session on using the software, patients will be asked to work with the software in practice and to see if the researcher has learned to work with the software to ask questions in case of any ambiguity. The patients' blood pressure will be measured before intervention in the intervention group and their demographic questionnaire will be filled out. Software will be installed in the intervention group's patients for six weeks and patients will be required to use this software and program after six weeks. This group will be measured and their demographic and quality of life questionnaire will be filled after the intervention.
Category
Prevention
2
Description
"Control group:"Routine care
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Madani Haspital
Full name of responsible person
Fereshteh Falah
Street address
Sadi alley;Karim khan Ave
City
Khoramabad
Province
Lorestan
Postal code
6819755836
Phone
+98 66 3342 1427
Email
falahfereshteh407@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Zahra farsi
Street address
Sadi alley;Karim khan Ave
City
Khoramabad
Province
Lorestan
Postal code
6819755836
Phone
+98 66 3342 1427
Email
falahfereshteh407@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Fereshteh Falah
Position
Master of nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Sadi Alley;Karim khan Ave
City
Khoramabad
Province
Lorestan
Postal code
6819755836
Phone
+98 66 3342 1427
Email
falahfereshteh407@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Fereshteh Falah
Position
Master of nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Sadi alley;Karimkhan Ave
City
Khoramabad
Province
Lorestan
Postal code
6819755836
Phone
+98 66 3342 1427
Email
falahfereshteh407@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Fereshteh Falah
Position
Master of nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Sadi Alley;Karim khan Ave
City
Khoramabad
Province
Lorestan
Postal code
6819755836
Phone
+98 66 3342 1427
Email
falahfereshteh407@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
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