Protocol summary

Study aim
Determining The Effect of Distribution of Educational Materials via Electronic Method on the Price of Services, Usability and Information Satisfaction of Patients with Coronary Artery Disease
Design
Phase II feasibility study in a two-group interventional study with post-test design. Sampling will be done in a convenient manner and then samples will be divided into two groups by block allocation
Settings and conduct
CAD patients hospitalized in the heart department and patients referred to the health education clinic of Ghaem hospital in Mashhad
Participants/Inclusion and exclusion criteria
Informed Consent to participate in the study At least the reading and writing skills Aged 18-60 Having spoken, audible, visual and cognitive health and having a smart phone (the patient or their primary caregiver) Admitted to the heart section for at least 24 hours Stable hemodynamic status (patients who do not have an Indication for hemodynamic monitoring due to cardiac-respiratory instability)
Intervention groups
Educational materials including photos, animated pictures, written explanations and spoken explanations, electronically and via Wi-Fi, will be provided to the intervention group in the hospital at the time of admission for at least 24 hours and will be in an outpatient clinic. The educational content is identical with the intervention group in the form of a pamphlet to the supervisor of the educational hospital to provide the units of research in the control group at the time of admission for at least 24 hours and to be in the clinic as an outpatient
Main outcome variables
Price of Services Usability Information Satisfaction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180903040938N1
Registration date: 2018-10-31, 1397/08/09
Registration timing: prospective

Last update: 2018-10-31, 1397/08/09
Update count: 0
Registration date
2018-10-31, 1397/08/09
Registrant information
Name
Fahimeh Nikraftar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
nikraftarf961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Distribution of Educational Materials via Electronic Method on the Price of Services, Usability and Information Satisfaction of Patients with Coronary Artery Disease
Public title
The Effect of Distribution of Educational Materials via Electronic Method with coronary artery disease
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent to participate in the study At least the reading and writing skills Aged 18-60 Having spoken, audible, visual and cognitive health and having a smart phone (the patient or his primary caregiver) Admitted to the heart section for at least 24 hours
Exclusion criteria:
Unstable hemodynamic status (Patients who have monitoring indication due to instability of hemodynamic status)
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 104
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: time blocking Randomization tool: SPSS statistical software
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
کمیته اخلاق دانشگاه علوم پزشکی مشهد
Street address
خيابان دانشگاه، چهارراه دكترا، خيابان ابن سينا، دانشكده پرستاري و مامايي
City
mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2017-10-06, 1396/07/14
Ethics committee reference number
IR.MUMS.NURSE.REC.1397.045

Health conditions studied

1

Description of health condition studied
Coronary artery disease
ICD-10 code
I20-I25
ICD-10 code description
Disease of circulatory system : Ischemic Heart Disease

Primary outcomes

1

Description
The cost of educational services provided to patients with coronary artery disease
Timepoint
During the intervention
Method of measurement
Researcher checklist

2

Description
The Usability by Patients with Coronary Artery Disease
Timepoint
24 hours after receiving educational materials
Method of measurement
Brooke's System Usability Scale (1996)

3

Description
Satisfaction with the information received in patients with coronary artery disease
Timepoint
24 hours after receiving educational materials
Method of measurement
Thomas & Associates Information Satisfaction Questionnaire (2004)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Educational materials including photos, animated pictures, written explanations and spoken explanations, electronically and via Wi-Fi, will be provided to the intervention group in the hospital at the time of admission for at least 24 hours and will be in an outpatient clinic.
Category
Other

2

Description
Control group: The educational content is identical with the intervention group in the form of a pamphlet to the supervisor of the educational hospital to provide the units of research in the control group at the time of admission for at least 24 hours and to be in the clinic as an outpatient
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem Hospital in Mashhad
Full name of responsible person
Fahimeh Nikraftar
Street address
Mashhad, Dr Ali Shariati Square, Beginning of Ahmadabad Street
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3840 0000
Email
nikraftarf961@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
فاطمه حشمتی نبوی
Street address
مشهد، خیابان ابن سینا، دانشکده پرستاری و مامایی
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 1853 9775
Email
heshmatinf@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
Fahimeh Nikraftar
Position
Masters student of Medical-Surgical Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ibn Sina Street, Faculty of Nursing and Midwifery, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
Email
nikraftarf961@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Heshmati Nabavi
Position
استادیار
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ibn Sina Street, Faculty of Nursing and Midwifery, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 1853 9775
Fax
Email
heshmatinf@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fahimeh Nikraftar
Position
Masters student of Medical-Surgical Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ebne- Sina Street, Faculty of Nursing and Midwifery, Mashad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
nikraftarf961@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
The total potential data can be shared after unidentifiable people
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
Health Centers
From where data/document is obtainable
Faculty of Nursing and Midwifery of Mashhad
What processes are involved for a request to access data/document
Immediately by visiting the Faculty of Nursing and Midwifery Faculty of Mashhad
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