Objective: Determining the effect of an educational-supportive intervention based on Orem model on self-care of patients with heart attack (myocardial infarction)
Method: Randomized clinical trial with intervention and control groups
Population: Patients with heart attack and history of hospitalization in 22 Bahman hospital
Inclusion criteria: 1) approved heart attack 2) at least one hospitalization for heart attack 3)up to three months passed from the last heart attack caused hospitalization 4) having no verbal and auditory problems and no mental, physical and psychological disabilities 5) willingness to participate in study
Exclusion criteria: 1) more than 3 months passed from the last heart attack caused hospitalization 2) no willingness to participate in study 3) unexpected events
Sample: 63 patients in each group
Intervention: The intervention groups consisted of three 21-members groups which will be educated with a face to face and group discussion method (universal, developmental and health derived requisites in three domains of awareness, motivation and proficiency). Each group will receive two 45-minutes educational sessions in one week. The follow up period will be 45 days, in which every 15 days the researcher contacts with samples and plan a visit in specified days of a week.
Study outcomes: If this intervention has positive effects on these patients, their ability will improved and it will be possible to participate them in different parts of their own self-care and they can reach to an appropriate level of self-care with taking responsibilities.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202219096N1
Registration date:2012-03-14, 1390/12/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-03-14, 1390/12/24
Registrant information
Name
Narjes Rahmati Sharghi
Name of organization / entity
Gonabad University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 53 3722 3028
Email address
rahmatin@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chansellor for Research, Gonabad University of Medical Sciences
Expected recruitment start date
2012-03-05, 1390/12/15
Expected recruitment end date
2012-05-04, 1391/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational – supportive intervention based on Orem model, on self care in patient with mayocardial infarction.
Public title
The effect of on Orem model, on self care in patient with mayocardial infarction.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Approved heart attack; At least one hospitalization for heart attack; Up to three months passed from the last heart attack caused hospitalization; Having no verbal and auditory problems and no mental, physical and psychological disabilities; Willingness to participate in study.
Exclusion criteria: More than 3 months passed from the last heart attack caused hospitalization; No willingness to participate in study; Unexpected events.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
126
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
Ethic Committe of Gonabad University of Medical Sciences
Street address
Asian Road, Gonabad University of Medical Sciences , Gonabad
City
Gonabad
Postal code
9691793718
Approval date
2012-02-25, 1390/12/06
Ethics committee reference number
ک ا/ 90/4/8
Health conditions studied
1
Description of health condition studied
Myocardial infarction
ICD-10 code
I23
ICD-10 code description
Certain current complications following acute myocardial infarction
Primary outcomes
1
Description
Educational – supportive System
Timepoint
Before and After Intervention
Method of measurement
Questionnaire based on OREM Model
Secondary outcomes
1
Description
Self care
Timepoint
Before and After Intervention
Method of measurement
Questionnaire based on OREM Model
Intervention groups
1
Description
Intervention group: The intervention group will be educated with a face to face and focus group discussion and will be supported, consulted and advised in universal, developmental and health derived requisites in three domains of awareness, motivation and proficiency. Samples will be divided into three 21-members groups and each group will receive two 45-minutes educational sessions in one week. The educational environment will be the same for all groups and be held in university or hospital (up to the patients mind). After finishing educational sessions, patients will be followed for 45 days and each 15 days the researcher will contact them by telephone calls and if needed patients receive individual education and consultation. Then the level of self-care in both control and intervention groups will be assessed.
Category
Rehabilitation
2
Description
control group: Without intervention
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahman 22 Hospital
Full name of responsible person
Street address
City
Gnabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Ekrami Ali
Street address
Asian Road, Gonabad University of Medical Sciences , Gonabad
City
Gonabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Rahmati Sharghi Narjes
Position
master student nursing
Other areas of specialty/work
Street address
Asian Road, Gonabad University of Medical Sciences , Gonabad
City
Gonabad
Postal code
9691793718
Phone
+98 53 3722 3028
Fax
Email
rahmati.n@gmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Rahmati Sharghi Narjes
Position
Master of nursing student
Other areas of specialty/work
Street address
Asian Road,Gonabad University of Medical Sciences , Gonabad
City
Gonabad
Postal code
Phone
+98 53 3722 3028
Fax
Email
rahmati.n@gmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Rahmati Sharghi Narjes
Position
master of nursing student
Other areas of specialty/work
Street address
Asian Road, Gonabad University of Medical Sciences , Gonabad
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)