Protocol summary

Summary
The purpose of this study: Determine the effect of a web-based education based on Health Promotion Model constructs on self-care behaviors of cardiovascular patients undergoing angioplasty treatment after discharge implementation. Inclusion criteria: over 18 years and less than 70 years old, having coronary artery disease and being in the first-degree angioplasty treatment (angina, acute coronary syndrome, myocardial infarction), not having a recommended special diet, no need for surgery, and access to the internet. Exclusion criteria: developing new physical problems, unwillingness to continue participation in the study at any time, not viewing the web-based educational content. This study is a randomized control trial on 152 patient (76 patient in the web-based group and 76 patient in the control group). The intervention group will receive a web-based education based on Health Promotion Model constructs and in control group patients receive routine training of the ward. Participants in both groups will complete questionnaires included demographic, health promotion model constructs (perceived benefits and barriers, perceived self-efficacy, perceived social support) awareness and self-care, before starting education. Two weeks after training and 3 months after the end of the program, both groups will be questioned and the results will be compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017080635429N2
Registration date: 2017-09-03, 1396/06/12
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-09-03, 1396/06/12
Registrant information
Name
Azime Khodaminasab
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 3436 0104
Email address
a.khodaminasab@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Bushehr University of Medical Sciences
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of web-based education on self-care in cardiovascular patients undergoing angioplasty treatment after discharge planning implementation: application of Health Promotion Model
Public title
effect of web-based education on self-care in cardiovascular patients undergoing angioplasty treatment
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: over 18 years and less than 70 years old؛ having coronary artery disease and being in the first-degree angioplasty treatment (angina, acute coronary syndrome, myocardial infarction)؛ not having cognitive problems based on medical records؛ not participating in another self-care program؛ a specific diet for the patient is not recommended ؛ left ventricular drainage fraction 40% ≥؛ no need for surgery and access to the internet. Exclusion criteria: developing new physical problems؛ unwillingness to continue participation in the study at any time؛ not seeing web-based educational content.
Age
From 78 years old to 27 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 152
Randomization (investigator's opinion)
Randomized
Randomization description
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 of Bushehr University of Medical Sciences
Street address
Salman Farsi Street, Bahmani, Bushehr, Iran
City
Bushehr
Postal code
Approval date
2017-07-17, 1396/04/26
Ethics committee reference number
IR.BPUMS.REC.1396.56

Health conditions studied

1

Description of health condition studied
Cardiovascular patients undergoing angioplasty
ICD-10 code
Z95.5
ICD-10 code description
Presence of coronary angioplasty implant and graft

Primary outcomes

1

Description
Self-care behaviors
Timepoint
Before the intervention, two week after the intervention and 3 months after intervention
Method of measurement
Self-care behaviors questionnaire (researcher provided)

Secondary outcomes

1

Description
Awareness
Timepoint
Before the intervention, two week after the intervention and 3 months after intervention
Method of measurement
Questionnaire awareness (researcher provided)

2

Description
Perceived benefits
Timepoint
Before the intervention, two week after the intervention and 3 months after intervention
Method of measurement
Perceived benefits questionnaire (researcher provided)

3

Description
Perceived barriers
Timepoint
Before the intervention, two week after the intervention and 3 months after intervention
Method of measurement
Perceived barriers questionnaire (researcher provided)

4

Description
Perceived Self-efficacy
Timepoint
Before the intervention, two week after the intervention and 3 months after intervention
Method of measurement
Perceived Self-efficacy questionnaire (researcher provided)

5

Description
Perceived social support
Timepoint
Before the intervention, two week after the intervention and 3 months after intervention
Method of measurement
Perceived social support questionnaire (researcher provided)

Intervention groups

1

Description
Intervention group: In the intervention group, at first, a how to use website guidance pamphlet and a card containing username and password to login the website will be given. in the next step, patients could watch the Health Promotion Model constructs-based training course on the website in a two week period. In addition, at the end of the training program up to 3 months after, will receive reminder messages to encourage to view the educational content uploaded on the website once a week via SMS. Evaluating will be done through questionnaire before the intervention, two weeks and 3 months after intervention.
Category
Lifestyle

2

Description
Control group: the control group patients receive routine training of the ward. Evaluating will be done through questionnaire before the intervention, two weeks and 3 months after the end of the intervention. After doing the final measurement, participants in the control group will receive a Website`s pamphlet guidance and a card containing username and password to view educational content.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Heart Therapeutic Center Hospital
Full name of responsible person
Dr Farhad Abbasi
Street address
Iran, Bushehr Province, Bushehr, Dadgosteri Crossroads, Heart Center Hospital.
City
Bushehr

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of research of Bushehr University of Medical Sciences
Full name of responsible person
Dr. Gholamreza khamisipour
Street address
Iran, Bushehr Province, Bushehr, Bahmani, Salman Farsi st, Bushehr University of Medical Sciences.
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of research of Bushehr University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Homamodin Javadzadeh
Position
Assistant Professor / PhD
Other areas of specialty/work
Street address
Iran, Bushehr Province, Bushehr, Bahmani, Salman Farsi st, Bushehr University of Medical Sciences.
City
Bushehr
Postal code
98
Phone
+98 77 3345 0084
Fax
Email
sh.javadzadeh@bpums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bushehr University of Medical Sciences, Bushehr
Full name of responsible person
Homamodin Javadzadeh
Position
Assistant Professor / PhD
Other areas of specialty/work
Street address
Iran, Bushehr Province, Bushehr, Bahmani, Salman Farsi st, Bushehr University of Medical Sciences.
City
Bushehr
Postal code
98
Phone
+98 77 3345 0084
Fax
Email
sh.javadzadeh@bpums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Bushehr University Of Medical Sciences
Full name of responsible person
Azime Khodaminasab
Position
MSc Student Of Health Education
Other areas of specialty/work
Street address
Iran, Bushehr Province, Bushehr, Bahmani, Salman Farsi st, Bushehr University of Medical Sciences.
City
Bushehr
Postal code
98
Phone
00
Fax
Email
Azimekhodam@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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