This research is a quasi-experimental study. Each research group is containing 66 persons that have criterions of entering the study. These groups are divided to 2 groups of test and control by draw. Each group are trained for a month (control group without researcher intermediation and based on department routine and test group with researcher intermediation according to Orem’s model). After one month from education, they fill self-care ability evaluation questionnaire. Study period for each group is two months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012090710772N1
Registration date:2012-10-27, 1391/08/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-10-27, 1391/08/06
Registrant information
Name
Khodadad Keshmiri
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0527
Email address
kh.keshmiri@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2012-11-21, 1391/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Orem’s self-care model application on self-care ability of patients with implantable cardioverter defibrillator
Public title
The self-care model application on patients with implantable cardioverter defibrillator
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Having the ability to understanding and speaking Persian; Having the tendency to cooperate and participate in the study; Having at least reading and writing ability; Implantable Cardioverter Defibrillator is placed to their body in the last two weeks; having at least four self-care necessities. Exclusion criteria: no willingness to continue participating in the study; not participating in more than one sessions; The patient death during the study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamedan University of Medical Sciences
Street address
Hamedan University of Medical Sciences
City
Hamadan
Postal code
6517838698
Approval date
2012-08-18, 1391/05/28
Ethics committee reference number
1834\9\35\16\پ\د
Health conditions studied
1
Description of health condition studied
Refractory arrhythmias or reversible
ICD-10 code
I47
ICD-10 code description
Ventricular tachycardia
Primary outcomes
1
Description
Self-care ability
Timepoint
Before the intervention, one month after intervention
Method of measurement
Self designed questionnaire to measure self-care
Secondary outcomes
empty
Intervention groups
1
Description
First meeting: Test group is divided to 3 groups of 8 persons and one group of 9 persons by their similar care requirements and self-care score. Self-care educating for test group according to Orem’s model is done 20 to 30 minutes per each week.Second meeting: At the beginning of this meeting, the importance of controlling signs of infection in these patients will be discussed. At the end of this meeting, the check list of self-care in the case of controlling signs of infection will be given to them. They will request to participate in third meeting one week later.Third meeting: At the beginning of this meeting, the importance of avoiding doing hard exercises will be discussed and participants are encouragement to do allowed movements. At later meetings, related check list is given to participants. They will request to participate in fourth meeting one week later.Fourth meeting: In forth meeting, the importance of time of reporting shock to doctor will be discussed. At the end of this meeting, the self-care check list will be given to participants.At the end of education meetings, the participants are requested to do their learnt things for one month
Category
Behavior
2
Description
Control group: routine care
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shaheed Rajai Cardiovascular Hospital
Full name of responsible person
Dr.Zahra Emkanjoo
Street address
Electrophysiology Center, Shaheed Rajai Hospital Cardiology -
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr.Khodayar Oshvandi
Street address
Hamedan University of Medical Sciences
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Khodadad Keshmiri
Position
Masters Student
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences
City
Hamadan
Postal code
Phone
+98 81 1838 0150
Fax
Email
kh_keshmiri57@yahoo.comkh.keshmiri@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr.Khodayar Oshvandi
Position
Assistant
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences
City
Hamadan
Postal code
6517838698
Phone
+98 81 1838 0150
Fax
Email
oshvandi@umsha.ac.iroshvandi2004@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Khodadad Keshmiri
Position
Masters Student
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences
City
Hamadan
Postal code
Phone
+98 118380150
Fax
Email
kh.keshmiri@umsha.ac.ir kh_keshmiri57@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)