The Effect of Nurse-Peer-Led Support Intervention on Quality of Life in Patients with an Implantable Cardioverter Defibrillator in Seyyed al Shohada university hospital Urmia in 2017-2018
The aim of this study was to determine the effect of applying nurse-peer-led support intervention on quality of life in patients with an implantable cardioverter defibrillator in Seyyed-Al-Shohada Hospital in Urmia.
Design
A clinical trial with a pre-post-test control group, randomized
Settings and conduct
From all participants was taken a pre-test with the MacNew quality of life questionnaire. Then participants were randomly divided into two groups intervention and control. In the intervention group, 6 people who had the highest quality of life scores and eligible peers were selected and 4 sessions 60 minutes about implantation defibrillator and its complications, self-care, and compatibility with the device were trained by the face-to-face method. The rest of the intervention group was divided into 6 groups of 9, and then each of their peers randomly entered one of the groups. The duration of nurse-peer-led support intervention sessions for each group was 4 sessions of 45 minutes. The venue for the sessions was in the specialty and subspecialty centers of the heart of Seyed-Al-shohada in Urmia.
Participants/Inclusion and exclusion criteria
Inclusion criteria for the study: 1) All patients with an Implantable Cardioverter Defibrillator 2) At least 3 months have passed since the insertion of Implantable Cardioverter Defibrillator.
exclusion criteria for the study: 1) Unwillingness to continue to participate in this study by the patient
Intervention groups
In the intervention group, a nurse-peer-led support intervention was implemented for five months from the beginning of February to the end of July and quality of life rate in patients with an implantable cardioverter defibrillator in the two groups before and after the appalling of nurse-peer-led support intervention were analyzed.
Main outcome variables
Quality of life and its dimensions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180808040742N1
Registration date:2018-08-28, 1397/06/06
Registration timing:retrospective
Last update:2018-08-28, 1397/06/06
Update count:0
Registration date
2018-08-28, 1397/06/06
Registrant information
Name
Yaser Moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3336 7978
Email address
y.moradi@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
2017-11-11, 1396/08/20
Actual recruitment end date
2018-02-04, 1396/11/15
Trial completion date
empty
Scientific title
The Effect of Nurse-Peer-Led Support Intervention on Quality of Life in Patients with an Implantable Cardioverter Defibrillator in Seyyed al Shohada university hospital Urmia in 2017-2018
Public title
The Nurse-Peer-Led Support Intervention and Quality of Life in Patients with an Implantable Cardioverter Defibrillator
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with an Implantable Cardioverter Defibrillator
At least 3 months have passed since the insertion of Implantable Cardioverter Defibrillator.
Exclusion criteria:
Unwillingness to continue to participate in this study by the patient
The absence of more than two sessions of classes formed by nurses and peer
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization in this study was done based on a random number table.
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 Urmia University of Medical Sciences
Street address
Vice-chancellor for research of Urmia University of Medical Sciences, Resalat Blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2017-10-12, 1396/07/20
Ethics committee reference number
IR.UMSU.rec.1396.349
Health conditions studied
1
Description of health condition studied
patients with an implantable cardioverter defibrillator
ICD-10 code
Z95.0
ICD-10 code description
Presence of electronic cardiac devices
Primary outcomes
1
Description
Quality of Life Score in the McNew Questionnaire
Timepoint
Before the intervention and 15 days after the intervention
Method of measurement
MacNew quality of life questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 6 people who had the highest quality of life scores in the pre-test and eligible peers were selected and 4 sessions 60 minutes about implantation defibrillator and its complications, self-care, and compatibility with the device were trained by the face-to-face method. The rest of the intervention group was divided into 6 groups of 9, and then each of their peers randomly entered one of the groups. The duration of nurse-peer-led support intervention sessions for each group was 4 sessions of 45 minutes.
Category
Lifestyle
2
Description
Control group: The control group received routine care.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Seyyed-Al-Shohada Hospital in Urmia
Full name of responsible person
Sohrab Saadat
Street address
Seyyed-Al-Shohada Hospital, 17 shahrivar Blvd.
City
Urmia
Province
West Azarbaijan
Postal code
5712546325
Phone
+98 44 3237 5910
Email
Sorab.saadat1988@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Sohrab Saadat
Street address
No. 20, Mehrab Ave.
City
Urmia
Province
West Azarbaijan
Postal code
5714256365
Phone
+98 44 3238 3923
Email
Sorab.saadat1988@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia University of Medical Sciences
Proportion provided by this source
10
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
Oroumia University of Medical Sciences
Full name of responsible person
Sohrab Saadat
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Seyyed-Al-Shohada Hospital, 17 Shaahrivar Blvd.
City
Urmia
Province
West Azarbaijan
Postal code
5711452563
Phone
+98 443275910
Email
Sorab.saadat1988@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Alireza Rahmani
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Sero Road, Pardis Nazlou
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3275 4918
Email
Alirezarahmani2005@gmile.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Sohrab saadat
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 20, Mehrab Ave.
City
Urmia
Province
West Azarbaijan
Postal code
5711452536
Phone
+98 44 3238 3923
Email
Sorab.saadat1988@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
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available