Determine the effect of care program based on Imogene King's model of goal attainment on the quality of life in patients with myocardial infarction
Design
This is a randomized Single blinded clinical trial. 102 patients with MI were selected based on entry criteria and randomly assigned to two groups of intervention and control.The method of assigning intervention to individuals is randomized and random blocked blocks with block size 4
Settings and conduct
This study will be conducted in ccu departments of Golestan and Imam Khomeini hospitals in Ahvaz. after the sampling, randomization and obtaining written consent, McNew's quality of life questionnaire will be complete with the two groups .individuals in the intervention group will receive a care program based on Imogene King's model of goal attainment with these phrases:1-nursing assessment(the patient’s needs and goal identification);2–Planning with patient participation(determining nursing diagnoses, prioritizing agreed goals, and organizing training sessions);3-implementation(conducting 3-4 interactive sessions of at least 15 minutes between the nurse and the patient,presenting the educational content to patients);4– evaluation(determines the level of the goal achievement).The patients is followed up on the second and sixth week by telephone and at the fourth and eighth week by visiting.The control group will receive only routine care and education.In the eighth week ,McNew's quality of life questionnaire is completed by both groups.
Participants/Inclusion and exclusion criteria
Age between 30 and 65.The final diagnosis of myocardial infarction.Ability to communicate.Not having known mental and psychiatric disorders
Intervention groups
in the intervention group, a care program based on Imogene King's model of goal attainment is used.The control group receives only routine care and education
Main outcome variables
Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190130042564N1
Registration date:2019-04-22, 1398/02/02
Registration timing:registered_while_recruiting
Last update:2019-04-22, 1398/02/02
Update count:0
Registration date
2019-04-22, 1398/02/02
Registrant information
Name
Fereshteh Hadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3331 2334
Email address
hadi.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-13, 1397/12/22
Expected recruitment end date
2019-06-12, 1398/03/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of care program based on Imogene King's model of goal attainment on the quality of life in patients with myocardial infarction
Public title
The effect of care program based on Imogene King's model of goal attainment on the quality of life in patients with myocardial infarction
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age of people between 30 and 65
The final diagnosis of myocardial infarction by a doctor and recording in document
Ability to communicate
Understand the purpose of the study and the willingness to participate in the study
Not having known mental and psychiatric disorders
Exclusion criteria:
Death
Unwillingness to continue cooperation
Participate in another intervention
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
The method of assigning intervention to individuals is randomized and random blocked blocks with block size 4 (using the table for random permutations).
Blinding (investigator's opinion)
Single blinded
Blinding description
single blind means that only samples are unaware of being placed in the intervention or control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Blvd. Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-10-21, 1397/07/29
Ethics committee reference number
IR.AJUMS.REC.1397.775
Health conditions studied
1
Description of health condition studied
Myocardial Infarction
ICD-10 code
I21
ICD-10 code description
ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
Primary outcomes
1
Description
Quality of life
Timepoint
Before the intervention and two months after the intervention begin
Method of measurement
McNew's quality of life questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: .For individuals in the intervention group, a care program based on Imogene King's model of goal attainment is used. Thus, the nursing process is based on King's theory in four steps during the patient's admission. The steps in the King's Nursing Process include these steps. 1. The collection of basic information (data banks) and the list of problems (the database includes the history of nursing and the examination of health status.) 2. Plan and set goals (Goal List). 3. Implementation of care program. 4.Evaluation or Progress note. The patients is followed up on the second and sixth week by telephone and at the fourth and eighth week by visiting in the clinic.
Category
Treatment - Other
2
Description
Control group: The control group receives only routine care and education.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
ccu department of Golestan hospital
Full name of responsible person
Fereshteh Hadi
Street address
Farvardin Ave, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
61357-33118
Phone
+98 61 3374 3001
Email
hadi.f@ajums.ac.ir
2
Recruitment center
Name of recruitment center
ccu department of Imam Khomeini hospital
Full name of responsible person
Fereshteh Hadi
Street address
24 meters high street. Imam Khomeini Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6155887888
Phone
+98 61 3222 2818
Email
hadi.f@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badvi
Street address
Esfand St, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3333 3477
Email
info@ajums.ac.ir
Web page address
http://ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
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
Ahvaz University of Medical Sciences
Full name of responsible person
Fereshteh Hadi
Position
Master of Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Esfand St, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8383
Email
hadi.f@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shahram Molavinejad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Esfand St, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8383
Email
shahrambaraz@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ferashteh Hadi
Position
Master of Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Esfand St, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 613311159
Email
hadi.f@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
it is not the objective of this study.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available