Protocol summary

Summary
The aim of this clinical trial is to determine the effect of telephone follow up on complications of coronary artery bypass graft surgery i.e readmission in patients whom discharged from coronary artery bypass graft surgery in Rajaee Teaching Hospital in 2015. 120 patients before discharge from hospital randomly will divide into two group. Both two groups before discharge of the hospital will receive routine education about their necessary self-care at home by a nurse. Demographic and clinical data of the patients will be gathered. In the intervention group on the third to fifth days after discharge, telephone follow up will be conducted. The telephone follow up interviews include ten questions with yes and no answers. The questions are about the complications of bypass graft surgery. The collected Information during telephone interviews that indicate important potential health problems will report to the doctors. The control group will not receive any follow up phone calls. Both groups at 30th day of discharge will be considered for readmission due to complications after surgery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201412205866N28
Registration date: 2015-12-17, 1394/09/26
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-12-17, 1394/09/26
Registrant information
Name
Akram Sanagoo
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1443 0360
Email address
sanagoo@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research & Technology, Golestan University of Medical Sciences
Expected recruitment start date
2015-07-28, 1394/05/06
Expected recruitment end date
2016-03-07, 1394/12/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of telenursing (telephone follow up) after discharge on readmission due to complications of Coronary artery bypass graft surgery
Public title
The effect of telenursing (telephone follow up) after discharge on readmission due to complications of Coronary artery bypass graft surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: coronary artery bypass graft surgery for the first time; aged 30 to 70 years; the ability to answer questions;.access to a phone or a mobile home; not having other chronic diseases (including epilepsy; stroke; cancer ...); and history of major surgery (brain and pelvis) in the 6 months before admission in hospital; having hospitalization less than a week after surgery. Lack of referral to rehabilitation centers within a month after discharge. Exclusion criteria: patient's unwillingness to follow every step of the study; Doctors disagree
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: 120
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
Ethics Committee of Deputy for Research and Technology Golestan University of Medical Sciences
Street address
Golestan University Of Medical Sciences,Shastkola,Gorgan
City
Gorgan
Postal code
4934174515
Approval date
2015-07-23, 1394/05/01
Ethics committee reference number
IR.GOUMS.REC.1394.70

Health conditions studied

1

Description of health condition studied
coronary artery bypass graft
ICD-10 code
T82.2
ICD-10 code description
Mechanical complication of coronary artery bypass and valve grafts

Primary outcomes

1

Description
Readmission
Timepoint
30 days after discharge
Method of measurement
check list postoperative complications

Secondary outcomes

empty

Intervention groups

1

Description
Intervention is telephon follow up (Telenursing) of patients after coronary artery bypass surgery after discharge from hospital at home , on third and fifth day after getting dismissed from hospital , patients will recieve a phone call on behalf of the researcher.At this point phone form , which will be used to identify and examine the cases of side effects of surgery , will be filled by the researcher and relative consideration and consults will be offered.
Category
Prevention

2

Description
The control group . 30daye after getting dismissed from hospital for post cares-following side effects of heart surgery-patients will be examined.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Rajaee Cardiovascular Research Center
Full name of responsible person
Maryam Forouzesh
Street address
Rajay Hospital, Valiasr street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Dr Masood Khoshnya
Street address
Deputy of Research & Technology, Golestan University of Medical Sciences , Shastkola
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Golestan 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
Golestan University of Medical Sciences
Full name of responsible person
Maryam Frouzesh
Position
Ms Student of Critical Nursing Care
Other areas of specialty/work
Street address
Bouyeh School of Nursing & Midwifery, Golestan University of Medical Sciences , Shastkola
City
Gorgan
Postal code
49165568
Phone
+32 430360
Fax
+98 912 325 3672
Email
forouzeshmaryam@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Nursing Research Center , Golestan University of Medical Sciences
Full name of responsible person
Dr Akram Sanagoo
Position
PhD of Nursing Education , Dean of NUrsing Research Center
Other areas of specialty/work
Street address
Golestan University of Medical Sciences , Shastkola
City
Gorgan
Postal code
49165568
Phone
+32 430360
Fax
+32 430360
Email
a_sanagu@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Nursing Research Center, Golestan University of Medical Sciences
Full name of responsible person
Dr. Akram Sanagoo
Position
PhD of Nursing Education , Dean of NUrsing Research Center
Other areas of specialty/work
Street address
Nursing Research Center , Golestan University of Medical Sciences ,Shastkola
City
Gorgan
Postal code
49165568
Phone
+32 430360
Fax
+98 911 270 3978
Email
a_sanagu@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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