The effect of educational intervention, based on Pender's health promotion model on lifestyle and clinical outcomes of patients with myocardial infarction
The aim of this study is to determine the effect of educational intervention, based on Pender’s health promotion model on lifestyle and clinical outcomes of patients with myocardial infarction.
In this clinical trial study, 100 patients with myocardial infarction admitted to Shahid Madani Hospital in Lorestan, Iran will be selected and randomly assigned into two equal-sized groups of control or intervention. Using purposive sampling, the eligible patients will included in the study if they aged 30-60 years old, have no history of previous myocardial infarction and have at least an elementary school education. The intervention group will be educated based on Pender’s model and control group will be routinely educated. The cardiac knowledge, perceived benefits, barriers and self-efficacy to behavior questionnaires and health promotion lifestyle profile will be completed by the patients before and three months after the intervention and data will be compared in both groups. Also lipid profile, blood pressure, blood sugar and ejection fraction (EF) will be measured and compared in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201607236909N1
Registration date:2016-09-21, 1395/06/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-21, 1395/06/31
Registrant information
Name
Fatemeh Mohammadipour
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 3322 1546
Email address
f.mohammadipor@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Gonabad University of Medical Sciences
Expected recruitment start date
2014-07-19, 1393/04/28
Expected recruitment end date
2016-01-08, 1394/10/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational intervention, based on Pender's health promotion model on lifestyle and clinical outcomes of patients with myocardial infarction
Public title
The effect of educational intervention on lifestyle and clinical outcomes of patients with myocardial infarction
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients who have no history of previous myocardial infarction, with the age between 30 and 60 years, at least an elementary school education and the ejection fraction above 40 percent (according to doctor's approval);
Exclusion criteria: participation in rehabilitation programs in the control group and failure to participate in training sessions in the intervention group
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Ethics committee of Gonabad University of Medical Sciences
Street address
Vice chancellor for research and technology, Gonabad University of Medical Sciences, next to the Asian Road, Gonabad, Razavi Khorasan
City
Gonabad
Postal code
Approval date
2013-07-11, 1392/04/20
Ethics committee reference number
GMU.REC.1392.57
Health conditions studied
1
Description of health condition studied
Myocardial Infarction
ICD-10 code
121
ICD-10 code description
Acute myocardial infarction
Primary outcomes
1
Description
Lifestyle
Timepoint
Befor and three months after intervention
Method of measurement
Health Promotion Lifestyle Profile (HPLP)
2
Description
Lipid profile
Timepoint
Befor and three months after intervention
Method of measurement
Blood sample by auto analyzer BT3000
3
Description
blood pressure
Timepoint
Befor and three months after intervention
Method of measurement
Measuring arterial blood pressure by mercury sphygmomanometer
4
Description
Ejection fraction
Timepoint
Befor and three months after intervention
Method of measurement
Echocardiography
5
Description
Fasting blood level of glucose
Timepoint
Befor and three months after intervention
Method of measurement
Measuring blood glucose by glucometer before breakfast
Secondary outcomes
1
Description
Cardiac knowledge
Timepoint
Befor and three months after the end of intervention
Method of measurement
Cardiac knowledge questionnaire
2
Description
Perceive benefits to behavior
Timepoint
Befor and three months after the end of intervention
Method of measurement
Perceive Benefits to Behavior (PBB) questionnaire
3
Description
Perceive barrier to behavior
Timepoint
Befor and three months after the end of intervention
Method of measurement
Perceive Barrier to Behavior (PBB) questionnaire
4
Description
Perceived self-efficacy
Timepoint
Befor and three months after the end of intervention
Method of measurement
Perceived Self-Efficacy questionnaire
Intervention groups
1
Description
Intervention group: eight training sessions lasting 45 minutes, twice a week, including: two sessions about the nature of cardiovascular disease, risk factors and treatment options, one sessions about medication, two sessions on healthy nutrition, one session on mental health, relaxation and rest, exercise and consultation, one session about the types of allowed exercise activities, frequency and time of useful exercise, how to control the pulse rate and allowed exercise intensity
Category
Lifestyle
2
Description
Control group: routine training (education about medications, nutrition and authorized activity)