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The effect of telephone follow up after discharge on the symptom, complications and readmission in the patients after coronary artery bypass graft surgery.

Protocol summary

Study aim
Determining the effect of telephone follow up on the symptoms, complications and re-admission of patients after coronary artery bypass graft surgery
Design
Randomized clinical trial, with control group, with parallel groups
Settings and conduct
The present study is a clinical trial with 70 patients undergoing coronary artery bypass graft surgery in Hamedan. Patients will be randomly assigned to control and intervention.In intervention group within 3 weeks after discharge, a phone call is made with patients. During the call, will be asked about symptoms such as angina, shortness of breath, fatigue, depression, sleep problems and if there is any other problem during the last week. And the repetition of any of the signs, their severity, interactions with physical activity, and interference with the pleasure of life will be asked.In the control group, no special action will be taken
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who have been nominated for coronary artery bypass graft for the first time, Possibility to make phone calls Exclusion criteria: Dissatisfied to participate in the study, Having the other chronic diseases before cardiac surgery
Intervention groups
Within 3 weeks after discharge, a phone call is made with patients. During the call, will be asked about symptoms such as angina, shortness of breath, fatigue, depression, sleep problems and pain in the site of operation, swelling of the feet, flutter or increase heart rate, anxiety and anorexia, and if there is any other problem during the last week. And the repetition of any of the signs, their severity, interactions with physical activity, and interference with the pleasure of life will be asked.In the control group, no special action will be taken.
Main outcome variables
Signs of illness, complications and re-admission of patients

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160110025929N22
Registration date: 2019-04-29, 1398/02/09
Registration timing: prospective

Last update: 2019-04-29, 1398/02/09
Update count: 0
Registration date
2019-04-29, 1398/02/09
Registrant information
Name
Mehdi Molavi Vardanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3422 5056
Email address
m.molavi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-21, 1398/02/31
Expected recruitment end date
2020-05-20, 1399/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of telephone follow up after discharge on the symptom, complications and readmission in the patients after coronary artery bypass graft surgery.
Public title
Effect of telephonefollow up on the symptom, complications and readmission
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Possibility to make phone calls Patients who have been nominated for coronary artery bypass graft surgery for the first time Age between 40 to 70 years old
Exclusion criteria:
Having the other chronic diseases before cardiac surgery Dissatisfied to participate in the study
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Firstly, they are selected by available sampling method. For random allocation, they will be divided into two groups of control and intervention from 6 of quadri blocks by random allocation. Thus, the letter A for the intervention group and the letter B for the control group will be considered.
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 Hamadan University of Medical Sciences
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Approval date
2019-02-26, 1397/12/07
Ethics committee reference number
IR.UMSHA.REC.1397.967

Health conditions studied

1

Description of health condition studied
Ischaemic heart diseases
ICD-10 code
I21
ICD-10 code description
ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction

Primary outcomes

1

Description
Symptom of disease
Timepoint
After intervention
Method of measurement
Check-list

2

Description
complications
Timepoint
After intervention
Method of measurement
Check-list

3

Description
Readmission
Timepoint
After intervention
Method of measurement
Check-list

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Within 3 weeks after discharge, a phone call is made with patients. During the call, will be asked about symptoms such as angina, shortness of breath, fatigue, depression, sleep problems and pain in the site of operation, swelling of the feet, flutter or increase heart rate, anxiety and anorexia, and if there is any other problem during the last week. And the repetition of any of the signs, their severity, interactions with physical activity, and interference with the pleasure of life will be asked.
Category
Rehabilitation

2

Description
Control group: In the control group, no special action will be taken.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Farshchian hospital
Full name of responsible person
Masoud Khodaveisi
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
khodaveisi@umsha.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
s-bashirian@umsha.ac.i
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of research and technology
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
Hamedan University of Medical Sciences
Full name of responsible person
Masoud Khodaveisi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
khodaveisi@umsha.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Masoud Khodaveisi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
khodaveisi@umsha.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Nemat Chaghazardi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
n.chaghazardi543@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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