The clinical trial of the effects of education based on Orem self care model on the International Normalized Ratio(INR) and quality of life of patients with prosthetic heart valve
The aim of this clinical trial is to determine the effect of education based on Orem Self Care Model on quality of life and control of international normalized ratio (INR) in patients with prosthetic heart valves.The study population includes all patients with prosthetic heart valves that are treated with warfarin referred to Warfarin Clinic of Al-zahra Heart Hospital. The study sample (94) will be selected by convenience sampling method and then is divided into control and experimental groups by the random block.Include criteria includes use of warfarin for at least three months and irregularly referring to warfarin clinic. Exclusion criteria includes planning to get pregnant and lack of follow-up of the treatment on a regular basis..Patients in the experimental group are identified based on Orem's needs assessment questionnaire.The intervention includes self-care education for 8 hours on an individual basis that will design according to the needs of patients in the Orem supportive-educational system. The program will be consists of three face to face training sessions for each person and four telephone sessions. Control group receives no intervension. Data will be collected by "Mac New heart patients Quality of life questionnair " and "test results record form". INR tests of both groups of patients will be done before, one and two months after the intervention, and the findings will be recorded. Also, all participants will complete quality of life questionnair before and two months after the intervention .The expected impact of INR control is in the normal range and quality of life in the intervention group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016082829566N1
Registration date:2016-11-14, 1395/08/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-11-14, 1395/08/24
Registrant information
Name
Zeinab Mirzaei
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 5373 0201
Email address
elahi-m@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2016-11-05, 1395/08/15
Expected recruitment end date
2017-02-03, 1395/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The clinical trial of the effects of education based on Orem self care model on the International Normalized Ratio(INR) and quality of life of patients with prosthetic heart valve
Public title
The effects of education based on Orem self care model on the International Normalized Ratio(INR) and quality of life of patients with prosthetic heart valve
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:Have willingness to participate in the study;Take warfarin for at least three months ; Regular warfarin clinic visit or be in contact by phone; Have the ability to read and write; Age between 18 and 60 years old.
Exclusion criteria:Have decided to get pregnant ;Lack of follow-up of the treatment on a regular basis.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
94
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization is based on random blocks. So 23 blocks of 4 and one binary block is formed. Then the sequence of the blocks are randomly determined . The samples size will be equal in both groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Central Building Shiraz University of Medical Sciences;Zand Ave ;Shiraz.
City
Shiraz
Postal code
Approval date
2016-09-07, 1395/06/17
Ethics committee reference number
ir.sums.rec.1395.68
Health conditions studied
1
Description of health condition studied
Prosthetic Heart Valve
ICD-10 code
Z95.2
ICD-10 code description
Presence of prosthetic heart valve
Primary outcomes
1
Description
INR
Timepoint
Once a month
Method of measurement
INR tests
2
Description
Quality Of Life
Timepoint
The beginning and end of the study
Method of measurement
MacNew Quality of Life Questionnaire for cardiac patients
Secondary outcomes
empty
Intervention groups
1
Description
Group test: a self-care educational program held for 8 hours.This program is individually designed according to the needs of patients in the Orem supportive-educational system . Three face to face sessions training and four telephone sessions will be done for each person .
Category
Prevention
2
Description
Control group: In this group will not be any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Warfarin Clinic Heart Hospital Zahra
Full name of responsible person
Zeinab Mirzaei
Street address
Al zahra hospital; Sibuyeh Boul; Shiraz; Iran
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zeinab Mirzaei
Street address
Shiraz University of Medical Sciences;Zand Ave;Shiraz;Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Zeinab Mirzaei
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences;zand ave; Shiraz;Iran
City
Shiraz
Postal code
Phone
+7 136474254
Fax
Email
zeinab.mirzaei@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Zahra Khademian
Position
Phd
Other areas of specialty/work
Street address
Department of Nursing, School of Nursing and Midwifery (R), Shiraz University of Medical Sciences, Shiraz, Iran
City
Shiraz
Postal code
Phone
+7 136474254
Fax
Email
khademian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zeinab Mirzaei
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Shiraz;Student Blvd., Shiraz University, dormitory logo 6
City
Shiraz
Postal code
Phone
+7 136474254
Fax
Email
zeinab.mirzaei@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)