Protocol summary

Summary
The present clinical trial aimed to determine the effectiveness of a tele nursing program on cardiac self efficacy of patients with coronary artery disease. Inclusion criteria include a diagnosis of coronary artery disease by the cardiologist, age between 35-75 years, familiar with the Persian language, having the ability to read and write, stable physical condition, not having a mental disorder or mental and mobility disability, lack of a vision, speech and hearing problem, and having access to a phone and a mobile. Exclusion criteria include the patient's unwillingness to continue to participate in the study, hospitalization or death during the study, simultaneous participation in cardiac rehabilitation programs and changing in phone and mobile number and do not informing the researcher. Finally, 64 patients with coronary artery disease hospitalized in cardiology wards of Chamran hospital in Isfahan randomly placed in the experimental and control groups. During 3 months intervention, calls are established to the subjects twice a week in the first month and once a week during the second and third months and each week 6 messages are send to the subjects. The content of phone calls and text messages sent to the patients in the intervention group is associated with the self efficacy but in the control group is not associated with self efficacy. Collection of patients' data is performed before, immediately after and one month after the intervention with a demographic characteristics questionnaire and Sullivan's cardiac self efficacy questionnaire and data will be analyzed statistically.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015020821002N1
Registration date: 2015-03-15, 1393/12/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-03-15, 1393/12/24
Registrant information
Name
Saba Boroumand
Name of organization / entity
Isfahan University of Medical Sciences, faculty of nursing and midwifery
Country
Iran (Islamic Republic of)
Phone
+98 31 4546 6493
Email address
saba.boroumand@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research of Isfahan university of medical sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2014-11-21, 1393/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Examine the effectiveness of a tele nursing program on cardiac self efficacy in patients with coronary artery disease
Public title
The influence of a tele nursing program on cardiac self efficacy of patients with coronary artery disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: a diagnosis of coronary artery disease by the cardiologist; age between 35-75 years; familiar with the Persian language; having the ability to read and write; stable physical condition; not having a mental disorder or mental and mobility disability; lack of a vision, speech and hearing problem; having access to a phone and a mobile. Exclusion criteria: the patient's unwillingness to continue to participate in the study; hospitalization or death during the study; simultaneous participation in cardiac rehabilitation programs; changing in phone and mobile number and do not informing the researcher.
Age
From 35 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences, faculty of nursing and midwifery
Street address
Hezar Jerib Avenue, Isfahan, Iran
City
Isfahan
Postal code
81746-73461
Approval date
2014-09-17, 1393/06/26
Ethics committee reference number
393504

Health conditions studied

1

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

Primary outcomes

1

Description
cardiac self efficacy
Timepoint
Baseline, 3 months and 4 months after baseline
Method of measurement
Sullivan's cardiac self efficacy questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
During 3 months intervention, calls are established to the subjects in the intervention group twice a week in the first month and once a week during the second and third months and each week 6 messages are send to the subjects. The content of phone calls and text messages sent to the patients in the intervention group is associated with the cardiac self efficacy.
Category
Other

2

Description
During 3 months intervention, calls are established to the subjects in the control group twice a week in the first month and once a week during the second and third months and each week 6 messages are send to the subjects. The content of phone calls and text messages sent to the patients in the control group is not associated with the cardiac self efficacy.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Chamran hospital
Full name of responsible person
Saba Boroumand
Street address
Salman Farsi avenue, Isfahan, Iran
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of research of Isfahan University of Medical Sciences
Full name of responsible person
Dr Mahdi Nematbakhsh
Street address
Deputy of research, Isfahan University of Medical Sciences, Hezar jrib Avenue, Isfahan, Iran
City
Isfahan
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 Isfahan 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
Isfahan University of Medical Sciences, faculty of nursing and midwifery
Full name of responsible person
Mahin Moeini
Position
Msc of nursing, department of adult health, member of nursing and midwifery care research center, me
Other areas of specialty/work
Street address
faculty of nursing and midwifery, Isfahan University of Medical Sciences, Hezar Jerib avenue, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3792 2935
Fax
Email
moeini@nm.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences, faculty of nursing and midwifery
Full name of responsible person
Saba Boroumand
Position
bachelor of nursing (Msc student of nursing)
Other areas of specialty/work
Street address
faculty of nursing and midwifery, Isfahan University of Medical Sciences, Hezar Jerib avenue, Isfahan, Iran
City
Isfahan
Postal code
8345111111
Phone
+98 31 4546 6493
Fax
Email
saba.boroumand@nm.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences, faculty of nursing and midwifery
Full name of responsible person
Saba Boroumand
Position
bachelor of nursing (Msc student of nursing)
Other areas of specialty/work
Street address
faculty of nursing and midwifery, Isfahan University of Medical Sciences, Hezar Jerib avenue, Isfahan, Iran
City
Isfahan
Postal code
8345111111
Phone
+98 31 4546 6493
Fax
Email
saba.boroumand@nm.mui.ac.ir
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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