The aim of this study is to investigate the effect of self-care program based on Orem’s theory on the quality of life in patients with heart failure. In this quasi-experimental study, 60 patients, will be divided randomly into two intervention and control groups, randomly. After getting written consent, they will complete demographic and quality of life questionnaire will be completed. Then, self-care program education will be carried out based on Orem theory for intervention group and the control group will receive usual nursing cares. After two months, questionnaire of quality of life will be completed for both group and the results will be evaluated statistically. After the intervention, a package that includes brochures and pamphlets about the disease and its care will be delivered to patients in the control group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016081929420N1
Registration date:2016-11-03, 1395/08/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-11-03, 1395/08/13
Registrant information
Name
Salar Alizadeh
Name of organization / entity
Nursing and Midwifery Faculty of Urmia
Country
Iran (Islamic Republic of)
Phone
+98 44 5813 1411
Email address
alizadeh.s@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Urmia University of Medical Sciences and Health Services
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of appling of Orem’s self -care program on congestive heart failure patients’ quality of life
Public title
Effect of Orem’s self -care program on congestive heart failure patients’ quality of life
Purpose
Prevention
Inclusion/Exclusion criteria
Include criteria: The diagnosis of heart failure class II and III, according to consulting doctor; The lack of a history of mental illness and physical disabilities based on patient records; The lack of a history of heart surgery in the last 6 months based on patient records; Residence in the city of Orumiyeh; Lack of cognitive, hearing, and vision impairment; Lack of education in the department of medicine; Lack of formal training in heart failure patients; Having the ability and willingness to participate in the study; Ability to make phone calls
Exclude criteria: Lack of access with the patient by telephone and his family during the study (several times in a few days) ; Patient's unwillingness to continue participation in the study; Death due to illness or the occurrence of any event and the deterioration of the patient
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
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
Urumia University of Medical Sciences and Health Services
Street address
Emergency district، Resalat Blvd، Urmia
City
Urmia
Postal code
5714783734
Approval date
2016-06-04, 1395/03/15
Ethics committee reference number
ir.umsu.rec.1395.118
Health conditions studied
1
Description of health condition studied
Heart Failure
ICD-10 code
i27.9
ICD-10 code description
Pulmonary heart disease, unspecified
Primary outcomes
1
Description
Quality of Life
Timepoint
before intervention and 2 months after intervention
Method of measurement
MacNew Quality of Life questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Self-care program based on Orem's self-care model that includes a selection of information, attitudes and practices that Based on the needs of heart failure patients in 4 to 6 sessions of 45 minutes taught them
Category
Lifestyle
2
Description
control group will receive usual nursing cares
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Seyyedolshohada Educational and Treatment Center
Full name of responsible person
Salar Alizadeh
Street address
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Reserch Council of Urmia University of Medical Sciences
Full name of responsible person
Dr Iraj Mohebbi
Street address
Staff of Urmia University of Medical Sciences، Emergency Distract، Resalat Blvd، Urmia
City
Urmia
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Reserch Council of Urmia 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
School of Nursing and Midwifery
Full name of responsible person
Salar Alizadeh
Position
Master of Scince in Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery، University of Medical Sciences، Sero Road، Urmia
City
Urmia
Postal code
Phone
+98 44 3275 4961
Fax
Email
salaralizadeh93@yahoo.comalizadeh.s@umsu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Nader Aghakhani
Position
Assistant Professor
Other areas of specialty/work
Street address
School of Nursing and Midwifery، Nazloo College، Km 11 Sero Road، Urmia
City
Urmia
Postal code
Phone
+98 44 3275 4961
Fax
Email
naderaghakhani2000@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Salar Alizadeh
Position
Master of Nursing
Other areas of specialty/work
Street address
Urmia
City
Urmia
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)