Protocol summary

Study aim
The effect of cardiac rehabilitation based on multimedia on self-efficacy, illness perception and cardiac biomarkers in patients undergoing per cutaneous coronary intervention
Design
A randomized, controlled, double-blind, placebo-controlled clinical trial
Settings and conduct
After the approval of the Ethics Committee's approval and permission from the relevant authorities, they are referred to Alzahra Heart Hospital and affiliated to Shiraz Medical Sciences and selected in accordance with the rehabilitation ward of patients with inclusion criteria. After explaining, completing the questionnaire and taking blood samples from both groups, the educational content CD will be delivered to the patients in the intervention group, telephone fallow up. Patients, principal analysts, and researchers are not aware of the intervention or control group, and the unknown questionnaire is completed to allow blindness.
Participants/Inclusion and exclusion criteria
Inclusion: Patients undergoing per cutaneous coronary intervention; willingness to participate in research; access to computers, the ability to use a CD; enjoy normal hearing, vision, and mental power; access to telephones. Exclusion: Aortic stenosis less than 1 cm; Uncontrolled ventricular or atrial arrhythmia; grade 3 blockade without pacemaker; Uncompensated heart failure; Severe orthopedic problems preventing activity; Chronic mental illness
Intervention groups
After blood sampling, patients in intervention group will be given a CD, illness perception, self-efficacy, how to perform cardiac rehabilitation training, and phono fallowup and consult if needed. control group: only routine rehabilitation is done.
Main outcome variables
The effect of cardiac rehabilitation based on multimedia on self-efficacy, illness perception and cardiac biomarkers in patients undergoing per cutaneous coronary intervention

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190405043164N1
Registration date: 2020-04-06, 1399/01/18
Registration timing: registered_while_recruiting

Last update: 2020-04-06, 1399/01/18
Update count: 0
Registration date
2020-04-06, 1399/01/18
Registrant information
Name
Sara Fadaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5444 2893
Email address
sarafadaei56@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-10, 1398/10/20
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
"The effect of cardiac rehabilitation based on multimedia on self-efficacy, illness perception and cardiac biomarkers in patients undergoing per cutaneous coronary intervention referring to hospitals affiliated to Shiraz University of Medical Sciences
Public title
"The effect of multimedia rehabilitation education on self-efficacy, perception of heart disease and biomarkers in patients undergoing coronary intervention."
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with coronary artery intervention Willingness to participate in the research Access the computer and have the ability to use a CD on a computer for multimedia use Have normal hearing, vision and mental power to communicate with the researcher or patient's diagnosis No doctor's diagnosis of mental illness and acute cognitive impairment Access to the phone after discharge
Exclusion criteria:
Uncontrolled hypertension, resting systole greater than 180 mm Hg or diastole greater than 110 mm Hg Clear aortic stenosis smaller than 1cm detected. Uncontrolled ventricular or atrial arrhythmia and grade 3 block with no pacemaker diagnosed. unrecovered heart failure that has been diagnosed. metabolic diseases such as acute thyroiditis, hypokalaemia, hyperkalemia, uncontrolled diabetes, and fever or acute systemic disease that have been diagnosed. Severe orthopedic problems and severe musculoskeletal problems that impede activity. Diagnosed chronic mental illness or cognitive impairment
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups of 35 according to the regular allocation technique. First, by simple randomization, the first patient referred from the sealed envelope removes the control or intervention word in the target group, and this is done by hiding the patient. The patient will be placed in the opposite group in each follow-up group. Other subsequent clients are also included in the intervention and control groups as one. The randomization unit is the patient and the construction is in random order.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are blinded by the following methods: Patients referring to the intervention and control groups will be randomly assigned to the intervention and control groups based on the systematic random allocation technique; They don't have patients.  The blinding of the study evaluator was done as follows: Principal Investigator آوری Data collectors and people preparing the paper are not aware of patients in the control and intervention groups. The study information and telephone fallout are only available to the intervention group. The consultation is based on the needs of patients in the intervention group and the control group does not have information about the content of the study and telephone phonoop and consultation. Obviously, after one month and evaluation of the patients in the control group, training is provided to the control group according to their needs and study information.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
University of Medical Sciences,Zand ave,Shiraz
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Approval date
2019-07-28, 1398/05/06
Ethics committee reference number
IR.SUMS.REC.1398.685

Health conditions studied

1

Description of health condition studied
coronary artery disease rehabilitation
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Inflammatory Factors with Neutrophil; Eosinophil and platlet Checkpoint
Timepoint
30days
Method of measurement
CBC quantifier

2

Description
Self-efficacy score on Sullivan questionnaire
Timepoint
30days
Method of measurement
Sullivan questionnaire

3

Description
illness perception score in B-IPQ questionnaire
Timepoint
30days
Method of measurement
B-IPQ questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients who received multimedia illness perception and self-efficacy during 10-sessions (each on 20 min) in addition to routine rehabilitation training, after one month by blood sampling, changes in inflammatory factors, and by the ((B-IPQ )Questionnaire and Sullivan's self-efficacy Questionnaire changes in their illness perceptions and self-efficacy exams
Category
Rehabilitation

2

Description
Control group: Patients who receive only routine rehabilitation training and practice.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra heart hospital
Full name of responsible person
Rosta.Hojatollah
Street address
Sibooye Blvd.
City
Shiraz
Province
Fars
Postal code
۵۴۹۳۷-۷۱۶۴۹
Phone
+98 71 3739 8811
Email
hfcmanager@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ghasemi.Yones
Street address
Headquarters of Shiraz University of Medical Sciences, Zand Street, opposite Palestine Street, Shiraz
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Rakhshan.Mahnaz
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Fatemeh School of Nursing and Midwifery, Namazi Hospital, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
00987132305410-19
Email
mzrakhshan@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Rakhshan.Mahnaz
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Fatemeh School of Nursing and Midwifery, Namazi Hospital, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
00987132305410-19
Email
mzrakhshan@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fadaei.Sara
Position
MS student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Fatemeh School of Nursing and Midwifery, Namazi Hospital, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
۱۳۱۱۹ - ۷۱۹۳۶
Phone
+98 71 3647 4254
Fax
Email
sarafadaei56@yahoo.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
Only part of the data, such as information about the main outcome or the like, can be shared.
When the data will become available and for how long
Start of course 6 months after the article is published
To whom data/document is available
Employed in academic and scientific institutions
Under which criteria data/document could be used
The data will be accessible for similar scientific research and with respect to the rights of early researchers
From where data/document is obtainable
Email address, or website, and phone numbers
What processes are involved for a request to access data/document
Contact Fred Mosul by email sarafadaei56@yahoo.com
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