Protocol summary

Summary
This study is a randomized clinical trial in which the effects of self-management program on coping strategies will be examined. The population, coronary artery disease who underwent angioplasty in selected hospitals of Tehran University of Medical Sciences.Number of subjects in both intervention and control groups according to the amount of sample loss and variables studied with the estimation of statistical supervision 37 patients in each group is determined. Sampling method available and will be selected based on inclusion criteria. Participants will be divided randomly into control and intervention. Patients in the intervention group and control After stabilization of hemodynamics and physical conditions coping strategies will complete a questionnaire after angioplasty.The control group will receive training routine discharge without interference research and experimental group self-management training program to learn by the researcher. The program includes training for 30 to 40 minutes and get face to face and telephone follow-up training is scheduled. the tables are recorded on a daily basis. Training content according to references in the educational needs of patients with coronary artery disease and previous research in this area, with a focus on three areas of management, role management and emotional management is set. The book education risk factors, and correcting misconceptions that there is a misunderstanding about angina patients and employing ways to improve the level of physical activity, has been studied. Telephone follow-up schedule by one week, three weeks and six weeks after the intervention. Two months after discharge, the questionnaire will be completed by patients in both groups. Data will be analyzed by SPSS software

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016112431068N1
Registration date: 2017-05-01, 1396/02/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-05-01, 1396/02/11
Registrant information
Name
Maryam Esmaeili
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4402
Email address
esmaeili_m@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciensces
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self- management program on coping strategies in patients after angioplasty
Public title
The effect of self- management program on coping strategies in patients after angioplasty
Purpose
Other
Inclusion/Exclusion criteria
Inclusion Criteria:Having read and write; The age range between 30 and 60 years; perform angioplast; the company's previous lack of self-management course or similar training courses Exclusion Criteria: During the study the patients died; Patients in the acute phase; If the patient does not participate in the telephone intervention; Lack of consent to continue participating in the study
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 74
Randomization (investigator's opinion)
Not 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
Tehran University of Medical Sciences- school of nursing and midwifery
Street address
Schoool of Nursing and Midwifery, Nosrat St, Tohid SQ, Tehran, Iran
City
Tehran
Postal code
Approval date
2016-02-20, 1394/12/01
Ethics committee reference number
IR.TUMS.REC.1394.2013

Health conditions studied

1

Description of health condition studied
Coronary Artery Disease
ICD-10 code
125.1
ICD-10 code description
Atherosclerotic Heart Disease

Primary outcomes

1

Description
Coping Strategies with disease conditions
Timepoint
3 months
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
The control group will not receive any intervention.
Category
Other

2

Description
The program consisted of 30 to 40 minutes and get face to face and telephone follow-up training is scheduled. This training package includes manual intervention training activity table and implementation of goals, which is available to patients. Training content according to references in the educational needs of patients with coronary artery disease and previous research in this area, with a focus on three areas of management, role management and emotional management is set. The intervention sessions with the patient's consent before discharge for half an hour and then after discharge telephone follow-up is done to help patients. This intervention is done solely for the intervention group and the control group will not receive special intervention.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital Affiliated to Tehran University of Medical Sciences
Full name of responsible person
Maryam Esmaeili
Street address
School of Nursing and Midwifery, Nosrat St, Tohid Sq, Teran, Iran
City
Tehran

2

Recruitment center
Name of recruitment center
Shariati Hospital Affiliated to Tehran University of Medical Sciences
Full name of responsible person
Maryam Esmaeili
Street address
School of Nursing and Midwifery, Nosrat St, Tohid Sq, Teran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ziba Taghizadeh
Street address
School of Nursing and Midwifery, Nosrat St, Tohid Sq, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Maryam Esmaeili
Position
Assistant Professor
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Nosrat St, Tohid Sq, Tehran, Iran
City
Tehran
Postal code
IRAN
Phone
+98 21 6105 4402
Fax
Email
esmaeili_m@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Esmaeili
Position
Assistant Professor
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Nosrat St, Tohid Sq, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6105 4402
Fax
Email
esmaeili_m@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Esmaeili
Position
Assistant Professor
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Nosrat St, Tohid Sq, Tehran, Iran
City
Tehran
Postal code
Phone
+98 912 578 6095
Fax
Email
esmaeiliem@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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