Protocol summary

Summary
The purpose of this study is to investigate the effect of an educational intervention based on illness perception correction on control of some risk factors and incidence of acute coronary syndrome in patients with coronary artery disease. This work is a clinical trial study with a control group, with patients undergoing angiography hospitalized in cardiology and post-angiography unit. One hundred patients, having inclusion criteria for the study, were randomly divided into two intervention and control groups (fifty patients for each group). Inclusion criteria: Being a candidate for angiography, not having a history of acute coronary syndrome, not having mental disease, not having cognitive disorder, not being a subject for another study. Exclusion criteria: Not being diagnosed with coronary artery disease by angiography and deterioration of the patient's medical condition before completing the intervention. Random allocation was determined based on odd and even weeks. After completing informed consent, demographic information and the status of some cardiovascular risk factors (systolic blood pressure, diastolic blood pressure, triglyceride, total cholesterol, fasting blood glucose, body mass index, smoking) and illness questionnaire-revised (IPQ-R) were completed before performing the angiography in the control and intervention groups. The control group just received routine care of the unit. In comparison, the intervention group received illness perception correcting intervention individually for three sessions. Then, the intervention group was followed up with telephone contact for three months after discharge. Six months after the clinical trial, the illness perception questionnaire-revised was completed and the status of some cardiovascular risk factors (systolic blood pressure, diastolic blood pressure, triglyceride, total cholesterol, fasting blood glucose, body mass index, smoking) and the incidence of acute coronary syndrome in both groups were assessed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016010425842N1
Registration date: 2016-04-01, 1395/01/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-04-01, 1395/01/13
Registrant information
Name
Zahra Zolfaghari Lakeh
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3315 6918
Email address
roohani@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Zanjan University of Medical Sciences
Expected recruitment start date
2015-03-08, 1393/12/17
Expected recruitment end date
2015-05-15, 1394/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of an educational intervention based on illness perception correction on control of some risk factors and incidence of acute coronary syndrome in patients with coronary artery disease
Public title
Illness perception correction in patients with coronary artery disease
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Being a candidate for angiography; Being older than 18 years; Not having a history of acute coronary syndrome; Not having any mental disease; Not having any cognitive disorder; Not being a subject for any other study; Possibility of making a phone contact with the patient Exclusion criteria: Not being diagnosed with coronary artery disease by angiography; Deterioration of the patient's medical condition before completing intervention; Discharge before completing the intervention; Reluctance to cooperate with the study
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
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 Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Azadi Sq, Zanjan, Iran
City
Zanjan
Postal code
Approval date
2015-02-10, 1393/11/21
Ethics committee reference number
ZUMS.REC.1393.212

Health conditions studied

1

Description of health condition studied
Coronary artery disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease

2

Description of health condition studied
Acute coronary syndrome
ICD-10 code
I24.9
ICD-10 code description
Acute ischaemic heart disease, unspecified

Primary outcomes

1

Description
Illness perception
Timepoint
Before intervention, six months after intervention
Method of measurement
Illness Perception Questionnaire-Revised

2

Description
Fasting blood glucose
Timepoint
Before intervention, six months after intervention
Method of measurement
Enzymatic method

3

Description
Triglyceride
Timepoint
Before intervention, six months after intervention
Method of measurement
Enzymatic method

4

Description
Total cholesterol
Timepoint
Before intervention, six months after intervention
Method of measurement
Enzymatic method

5

Description
Systolic blood pressure
Timepoint
Before intervention, six months after intervention
Method of measurement
Aneroid sphygmomanometer

6

Description
Diastolic blood pressure
Timepoint
Before intervention, six months after intervention
Method of measurement
Aneroid sphygmomanometer

7

Description
Body mass index
Timepoint
Before intervention, six months after intervention
Method of measurement
weight (kg) / [height (m)]2, kg/m2

8

Description
Smoking
Timepoint
Before intervention, six months after intervention
Method of measurement
Questionnaire

9

Description
Incidence of acute coronary syndrome
Timepoint
Six months after intervention
Method of measurement
Patient's medical file and Diagnosis of the physician

10

Description
Length
Timepoint
Before intervention
Method of measurement
Measuring tape

11

Description
Weight
Timepoint
Before intervention, six months after intervention
Method of measurement
Scale

Secondary outcomes

empty

Intervention groups

1

Description
In control group no intervention was done.These patients just received routine care of the unit (routine nursing Care including carrying out doctors' orders, brief explanation on diet and medications at time of discharge)
Category
N/A

2

Description
In intervention group, an intervention on the basis of correcting the patient’s perception of the illness was carried out for three 30-40 minute sessions during hospitalization. The intervention was individually through the face-to-face conversation according to the response of each patient to the Illness Perception Questionnaire-Revised version. On discharge, the patients were supplied with an education booklet and CD. Then, the intervention group was followed up by telephone contacts for 20 to 30 minutes for three months after discharge. In this follow-up, the appropriate behaviors of the patients were encouraged, the benefits of adopting these behaviors were emphasized, and finally their questions were answered.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Mousavi Hospital, Zanjan
Full name of responsible person
Zahra Zolfaghari Lakeh
Street address
Gavazang Road, Zanjan, Iran
City
Zanjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Zanjan University of Medical Sciences
Full name of responsible person
Dr Mohamad Masood Vakili
Street address
Vice Chancellor for Research of Zanjan University of Medical Sciences, Azadi Sq, Zanjan, Iran
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Mahin Roohani
Position
Master of Nursing
Other areas of specialty/work
Street address
Zanjan School of Nursing and Midwifery School, Haj Ahmad Mahdavi Sq, Zanjan, Iran
City
Zanjan
Postal code
Phone
+98 24 3315 6918
Fax
Email
Roohani@zums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mahin Roohani
Position
Master of Nursing
Other areas of specialty/work
Street address
Zanjan School of Nursing and Midwifery School, Haj Ahmad Mahdavi Sq, Zanjan, Iran
City
Zanjan
Postal code
Phone
+98 24 3315 6918
Fax
Email
Roohani@zums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Zahra Zolfaghari Lakeh
Position
Ms Critical Care Nursing Student
Other areas of specialty/work
Street address
Zanjan School of Nursing and Midwifery School, Haj Ahmad Mahdavi Sq, Zanjan, Iran
City
Zanjan
Postal code
Phone
+98 24 3315 6918
Fax
Email
Zolfaghari_zl@yahoo.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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