Effect of Lifestyle Modification Intervention on Health Status of Coronary Artery Disease Patients : Randomized Control Trial

Background: Coronary artery disease is a major cause of morbidity and mortality throughout the world. Modification of life style can be achieved by patients' education to improve their health status. Aim: To evaluate effect of lifestyle modification intervention on health status of coronary artery disease patients. Design: Randomized control trial used to achieve the aim of this study. Setting: The current study conducted at the coronary care unit and cardiology out-patient clinics of Benha University Hospital, Benha City. Subjects: Purposive sample of 92 coronary artery disease patients (study and control) were included in the study. Tools: Two tools used in this study 1) Interview questionnaire. 2) Health status questionnaire. Results: Significant percentage of the study participants from both groups were adhered to unhealthy life-style practices as smoking, eating salty and fatty foods, drinking tea and coffee as well as they didn't practice exercises and recreational activities. After lifestyle modification intervention, there were significant statistical differences between the two groups favoring the study group regarding all aspects of health status; physical function, bodily pain, social function, role limitation due to physical or emotional problems and mental health (P<0.05). Conclusion and recommendations: This study concluded that life style modification intervention for coronary artery disease patients is effective and useful for enhancing their health status. This study recommended that coronary artery patients` education should be held in permanent approach, because it is a crucial part of their treatment.


Introduction
Cardiovascular disease is a main cause of mortality and disability in spite of extensive hard work to manage cardiac risk factors in the course of diet, exercise, and medications (Roger, et al 2012).Cardiovascular disease (CVD) comprises all diseases of the circulatory system, cerebro-vascular disease, hypertension, peripheral arterial disease, rheumatic heart disease, congenital disease, heart failure, deep vein thrombosis and pulmonary embolism and coronary heart disease (Go, et al, 2014).Coronary artery disease (CAD), as well referred to as coronary heart disease (CHD), is the tapering of the small blood vessels that deliver blood and oxygen to the heart (United States National Library of Medicine, 2016).Coronary artery disease (CAD) incorporates acute myocardial infarction, other acute ischemic heart disease, angina pectoris, atherosclerotic cardiovascular disease, and all other types of chronic ischemic coronary heart disease (Go, et al, 2014).
The cardiovascular risk factors are classified as non-modifiable or modifiable risk factors.Non-modifiable risk factors comprise age, sex, family history, and having a prior heart attack.Modifiable risk factors are hypertension, hyperlipidemia, diabetes mellitus, and smoking (Framingham, 2016).Clinical data verified that a sedentary lifestyle, stress and fatty diet are important modifiable risk factor for CAD (Weberg, 2013).Health care workers didn't succeed to modify mainly preventable (modifiable) risk factors and the crisis of cardiovascular risk and disease incidence subsists due to poor management of modifiable risk factors (Wachira, & Stys, 2013).There are numerous clinical strategies that suggested lifestyle modifications for the prevention and the treatment of CVDs which included complete smoking cessation, blood pressure control, lipid management, physical activity, weight management, type two diabetes mellitus management, medication, and cardiac rehabilitation (Smith et al, 2011).A healthy diet, regular exercise, avoiding smoking, depression and further psychosocial activities, offer reimbursement to patients with CAD so patient education about lifestyle modification, execution approaches and follow up on a continuing foundation to achieve secondary prevention.Successful coronary revascularization and treatment ought to be accomplished by superior labors to recognize and modify risk factors and their original causes (Brinks et al, 2017).
Providing sufficient knowledge about CAD through cardiac educational program is supposed to be an essential obligation that enhanced knowledge, awareness, attitudes, and beliefs for compliance to healthy lifestyle (Eshah, Bond, &, Froelicher, 2010).Cardiac patient education is a vital element of nursing care aimed at supporting those patients to take care of themselves (Fredericks et al, 2010) Nurses have a chief responsibility to instruct, assist and guide patients to create lifestyle changes.Nurses are capable of providing professional information and assistance in either a counseling or rehabilitation setting via a holistic approach to care.Smoking termination, relaxation techniques and stress management can be carried out with the patient and his/her health care provider in a relaxed, familiar manner (Coster, & Norman, 2009).

Significance of the Study
According to WHO statistics, about 17.7 million people die each year from CVDs, an estimated 31% of all deaths all over the world.Most of CVD deaths occur in low-income and middle-income countries, while 80% of all CVD deaths are caused by coronary heart disease and strokes.It is estimated that 54% of deaths from non-communicable diseases in the Eastern Mediterranean Region are due to cardiovascular diseases.The Region has higher rates of physical inactivity than other regions (World Health Organization, 2017).
Coronary heart disease deaths in Egypt reached 107,232 or 23.14% of total deaths.The age adjusted death rate is 186.36 per 100,000 of population ranks Egypt as the 23 in the world (World Health Organization, 2014).Triggering coronary artery diseases are smoking, unhealthy diet, physical inactivity and the hurtful use of alcohol.These in turn show up in people as elevated blood pressure, hyperglycemia, overweight and obesity, risks injurious to good quality heart health (World Health Organization, 2017).Great quantity of deaths can be reduced by modifying risk factors and obedience to healthy life style and this concern need extreme effort to progress knowledge of patients (Ahmad, A., Tawalbeh, 2015).For this reason the researchers conducted this study to help those patients to adhere to healthy lifestyle to enhance their health status.

Aim of the Study
This study aimed to evaluate effect of lifestyle modification intervention on health status of coronary artery disease patients through: Assess patients' health status and its related variables.
Develop and implement life style modification intervention for the study group.
Evaluate effect of life style modification intervention on health status of coronary artery disease patients (study group).

Research Hypothesis
Health status among the study group will be enhanced after execution of lifestyle modification intervention on health status compared to control group.

Subjects and Methods
Research design: randomized control trial used to achieve the aim of this study.

Setting
The current study conducted at the coronary care unit (CCU) and cardiology out-patient clinics of Benha University Hospital, Benha city.The coronary care unit consists of two rooms, the big one contains eight beds and the small room included four beds.Both rooms are equipped by all necessary devices and equipment needed for care of coronary artery patients.

Sample
A purposive sample of 92 coronary artery patients (angina and MI) included in this study.Patient with other chronic disorders were excluded from the study.Sample size determined based on a previous study reported that health status score was significantly improved in the study intervention group from 4.8 ±1.0 to 5.1 ±0.9 (Lourenç o et al., 2015).Considering level of significance of 5%, and power of study of 80%, the sample size can be calculated using the following formula: Therefore, n= [(1.96 + 0.84) 2 × {2(0.9) 2 }]/ (0.53) 2 =45.2.Based on the above formula, the sample size required per group is 46.

Tools of Data Collection
Two tools utilized for data collection in the current study.

Tool I
Interview questionnaire; it involved two parts: Part 1: Socio-demographic data of the study participants.
Included information about study participants' age, gender, marital status, residence, educational level and occupation.
Part 2: Assessment of lifestyle practices; It was developed by the researchers after reviewing of related literature (Timby &Smith 2010 andLibby et al. 2008).It is a likert like scale with five options; repeatedly, often occasionally, rarely and never to assess lifestyle practices among the study participants.It included practices of smoking; (three items) practicing cigarette smoking, other types of tobacco used and daily intensity of smoking practices, eating unhealthy foods; (five items) eating fatty foods, eating fast foods, eating frying foods, eating salty foods and eating canned foods.Having unhealthy drinks; (three items) drinking coffee, tea and fatty drinks and practicing activities (three items) practice exercises, walking and recreational activity.
Scores for smoking ranged from 3 to 15.
Scores for eating unhealthy foods ranged from 5 to 25.
Scores for having unhealthy drinks ranged from 3 to 15.
Scores for practicing activities ranged from 3 to 15.
Total lifestyle practices scores ranged from 14 to 70, and classifies as the following: Scores from 14 to < 30 reflects poor lifestyle practices Scores from 30 to < 50 reflects fair lifestyle practices Scores ≥ 50 or more reflects good lifestyle practices 3.3.2Tool II Health status questionnaire: adapted from Ware and Sherbourne (1992).It is an instrument for measuring health status and outcomes from the patient's point of view, measuring eight dimensions; physical function, role limitation caused by physical problems, role limitations caused by emotional problems, mental health, energy/fatigue, bodily pain, social function and general health perception.It consists of five parts (scales): Part 1: Physical function consisted of 10 items distributed on a scale of three options; yes, limited a lot (0 mark), yes, limited a little (50 mark) and no not limited at all (100 mark).
Part 2: Comprised role limitation caused by physical problems (3 items) and role limitations caused by emotional problems (3 items), both distributed on a scale of two options; no (0 mark) and yes (100 mark).
Part 3: Included mental health (5 items) and energy/fatigue (4 items), both spread on a scale of six options, all of the time (0 mark), most of the time (20 mark), a good bit of the time (40 mark), a little of the time (60 mark), some of the time (80 mark) and non of the time (100 mark).
Part 4: Contained bodily pain (2 items) and social function (2 items), both dispersed on a scale of five options; extremely (0 mark), quite a bit (25 mark), moderately (50 mark), a little bit (75 mark) and not at all (100 mark).

Scoring System
The Health status questionnaire is divided into five scales, each item in each scale is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.Scores represent the percentage of total possible score achieved, items averaged together to create each scale.Total health status scores were categorized as the following: Scores from 0 to < 40 reflects poor health status Scores from 40 to < 60 reflects fair health status Scores ≥ 60 reflects good health status

Content Validity
Tools were evaluated by three experts in medical-surgical nursing and two cardiologists tested the content validity.The tools and booklet adapted according to the experts' suggestion.

Tools Reliability
Reliability of tool I was tested through a pilot study by using Cronbach's α (alpha=0.73)for tool II, and α (alpha=0.85)for tool II, hence the questionnaire was found to be highly reliable.

Ethical Considerations
An ethical approval was attained from the Dean of Faculty of Nursing at Benha University to apply this study following explaining its aim.An informed written consent was gained from the study's participants and they were informed about their optional involvement in the study and that they have the right to withdraw from the study at any time.Participants assured that their rejoinder would be covert and only cumulative data would be conversed.After the study was fulfilled, handout about life-style modification was dispersed to the control group.

Pilot Study
A pilot study conducted on 10% of the study subjects' in order to assess the suitability and implication of the study tools and to test clarity of the questionnaire as well as to estimate the time needed to answer them; and then the essential modification done and these subjects excluded from the study sample.

Field Work
A written official conformity was obtained from the Director of Benha University Hospital and the head of coronary care unit to carry out the study after clarification of its purpose.It was conducted through four phases: assessment, planning, implementation, and evaluation.These phases were executed over eight months from the beginning of December 2017 to the end of July 2018.

Assessment Phase
After obtaining official agreement for study conduction, the researchers interviewed the coronary artery patients of both groups to explain the aim and procedures of the study and solicit for their cooperative contribution and written consents obtained from them and assured that data will be confidentially secured and they have the right to withdraw from the study at any time.Subjects were interviewed individually to assess their sociodemographic characteristics, assess their lifestyle practices and assess their health status by the use of the study tools.The data was obtained during this phase represented the baseline for further comparisons to assess the effect of the intervention.The control group was assessed firstly to prevent cross contamination of data.

Planning and Implementation Phase
Based on the requirements recognized in the assessment phase from the study group and in view of the allied literature, the researchers established a power point presentation about healthy life style for coronary artery patients with simple arabic language to suit patients' level of comprehension, as well as demonstration of procedures as coughing and breathing exercises.It insisted on the regions of chief deficit in patients' knowledge and unhealthy habits which included definition, incidence, risk factors, signs and symptoms, management measures, healthy foods, healthy eating habits, practicing exercises, activities and weight reduction, as well as blood pressure control, smoking cessation and stress management.The educational intervention involved five sessions that were conducted on small group (8-10) of the study group in out-patient clinics.It was achieved according to participants' physical and mental willingness.The duration of each session lasted from 20-30 minutes including periods of discussion according to their understanding, progress and feedback.Different methods of teaching were used such as lecture, power point, group discussion and brainstorming as well as a booklet containing all illustrations about health style modification with pictures was given to study group.

Evaluation Phase
After the educational intervention; its effect was evaluated by using the same health status questionnaire of pre-test after four months of intervention using post-test which was conducted for the control group first then the study group.

Statistical Analysis
All statistical analyses were performed using SPSS for windows version 20.0 (SPSS, Chicago, IL).Data were tested for normality of distribution prior to any calculations.Continuous data were expressed in mean ±standard deviation (SD) while categorical data were expressed in number and percentage.Chi-square test was used for comparison of variables with categorical data.Statistical significance was set at p<0.05.

Results
Table 1 shows that, there was no statistically significant difference between socio-demographic characteristics within the two groups (P >0.05).More than half of the study and control groups were females (56.5 & 52.2), while half of the study group and more than half of the control group lived in rural area (50% & 56.5%) and also more than half of them were working (58.7% & 63%) respectively.The majority of the study and control groups were married (78.3% & 80.4%), while only about one third of them were read and write (37% & 34.8%) respectively.
Figure 1 illustrates that, more than half of the studied patients had 50-69 and 60-69 years (26.1 & 34.8%) respectively, while in control group there was about two thirds of the patients had 50-69 and 60-69 years of age with (32.6% &32.6%) respectively.
Figure 2 shows that, distribution of diagnosis within the two groups, high prevalence of angina pectoris than MI within control and study groups were (76.1%, 69.6%) respectively.
Table 2 represents that mean score of total lifestyle practices among the studied patients were (43.1 ±9.2 & 40.3 ±8.2) for the study and control group respectively which fair lifestyle practices.Table 3 shows that, there was no statistically significant difference between the two groups before intervention regarding physical function (P >0.05), while there was statistically significant difference after four months of intervention between them regarding all aspects of physical function (P<0.05).Additionally, there was no statistically significant difference between pre and post intervention within the control group, while there was statistically significant difference pre and post intervention within the study group.
Table 4 represents that, there was no statistically significant difference between the two groups pre intervention regarding role limitation (P >0.05), due to physical problems, bodily pain and social function while there was statistically significant difference after four months of intervention regarding role limitation (P<0.05).Furthermore, there was no statistically significant difference between pre and post intervention within the control group, while there was statistically significant difference pre and post intervention within the study group.
Table 5 demonstrates that, there was no statistically significant difference between the two groups before intervention regarding mental health and role limitations caused by emotional problems (P >0.05), while there was statistically significant difference after four months of intervention between them (P<0.05).In addition, there was no statistically significant difference between pre and post intervention within the control group, while there was statistically significant difference pre and post intervention within the study group.
Table 6 explains that, there was no statistically significant difference between the two groups before guidelines intervention regarding energy/fatigue and general health (P >0.05), while there was statistically significant difference after four months of intervention between them (P<0.05).Furthermore, there was no statistically significant difference between pre and post intervention within the control group, while there was statistically significant difference pre and post intervention guidelines within the study group.
Table 7 presents that, there was no statistically significant difference between the two groups before intervention regarding health status (P >0.05), while there was statistically significant difference after four months of intervention between them (P<0.05).Additionally, there was no statistically significant difference between pre and post intervention within the control group, while there was statistically significant difference pre and post intervention within the study group.Total health status score for the study and control group Mean ±SD (46.9 ±18.1 &45.9 ±16.6) which reflects fair health status pre intervention, while it improved to (63.2 ±14.5) for the intervention group after 4 months of intervention that reflects good health status.P<0.001Within groups *: Significant at P ≤ 0.05

Coronary Heart Disease Is the Primary Cause of Mortality Worldwide
Cardiovascular diseases is accountable for about 10% of the total load of a disease every year in low-and middle-income countries and 18% in high income countries (World Health Organization, 2013).In the Middle East, there is a fairly elevated mortality from CVD.The age-standardized cardiovascular death rates in countries as Iraq, Yemen, Egypt, Lebanon, and Jordan, are two times higher than the proportional figures for the United States.About 25-40% of deaths in several Arab countries are due to cardiovascular diseases.Which, these risk factors contribute to the growing burden of strokes, heart failure, MI and peripheral vascular disease (Shantouf, 2012).

5.2
Reviewing socio-demographic characteristics of the study sample of the present study revealed that, the studied patients from the study and control group were homogenous as regard to their socio-demographic characteristics where they had no significant statistical differences.These results are consistent with Salameh, et al. (2012) who reported similarity in the intervention and control groups regarding their socio-demographic data.

5.3
Smoking cessation is the most valuable and the most gainful factor of all the lifestyle modification intervention that suggested to prevent CAD, the current study showed serious findings, as the studied patients from both groups had low scores regarding smoking practices.This finding was in the same line with a study done by Aslanabadi, et al. (2008) showed that prior applying a lifestyle modification intervention, 30% of the patients in the study group and in the usual care group were smokers.Also, Dehghani, et al., (2015) noted that more than half of the study participants were smokers at baseline assessment.
5.4Extreme caffeine intake is a risk factor for CAD, however it still practiced by CAD patients.This fact was reported in the present study, as the study participants from both groups had low scores regarding having unhealthy drinks, as tea, coffee and fatty drinks this may be referred to the egyptian culture where they consider tea and coffee the popular drinks in Egypt.This finding was in the same line with (Abd-Elmawlaa, 2010), who found that majority of the sample (less than two-third) were drinking tea and coffee and didn't want to stop them.Regarding salt and fatty food intake, the current study demonstrated that the study participants from both groups had low scores regarding eating unhealthy food as salty and fatty foods, this may be attributable to eating habits of egyptian people that depending mainly in preparing meals containing frying foods, which is congruent with Khalife-Zadeh, Dorri, & Shafiee (2015) who noted that their study participants had hyperlipidemia.In addition Safabakhsh, et al.(2016), conducted a study to determine the impact of a health promotion program on behavior in terms of the dimensions of the health promoting lifestyle profile in patients after coronary artery bypass graft, they discovered that the majority of the study participants were eating fatty foods.According to the present study the study participants from both groups had low scores regarding practicing activities like walking, physical exercise, and recreational activity this may be due to the presence of technology in our life that permits subjects to do most of their tasks without movement.These results are confirmed by the findings of the previous studies (Young, 2005;Cox, 2007& Maddison et al, 2014) who noted reduction among main part of participants concerning practice of exercises and recreational activities.Furthermore, Safabakhsh, et al. (2016), concluded that, the majority of participants in the experimental and control groups had a sedentary lifestyle and didn't perform exercises.

5.5
There was statistically significant difference after four months of intervention between the study and control groups regarding physical function, and role limitation due to physical problems, this may be related to the positive effect of activity on improvement of the circulation and strength of the cardiac muscle.In this regard, it has been shown that unsuccessful behavior change related to physical restrictions had a harmful effect on the progress of ischemic heart disease patients (Peterson et al., 2010).While, exercise have to be sustained for long-term to achieve the enhancement (Herdy, Marcchi & Vila, 2008).Moreover, patients' hard work tolerance advanced extensively with exercise performance (Giallauria et al, 2008).That is consistent with, Salameh, et al. (2012), found that, the initial assessment of physical activity established a similarity between the two groups and improvement in the intervention group after education.Moreover Dehghani, et al., (2015) showed a considerable raise in physical activity in the study group as compared to the control group after six months to baseline data.These findings are in contrast to Eshah, (2011) who reported that patients have little scores in the physical function result from the shortage in informational programs and rehabilitation services.

5.6
There is a significant enhancement in the pain sensation among the study group post four months of life-style modification intervention as reported by the results of the current study.This finding is congruent with Saeidi, et al.,(2013), who discovered a significantly progress in bodily pain scores among the study participants compared to baseline scores.While this result is inconsistent with Yu et., al. (2004) who demonstrated that the intervention group had better scores in all domains of life style modifications, but differences between groups were no longer significant.There were no longer any statistically significant differences between groups in the percentage of participants complaining chest pain, and deterioration of chest pain.

5.7
The social position of the patients is a very important parameter that must be taken in mind when organizing a multidisciplinary intervention, in this regard, this study showed that, there was statistically significant difference after four months of intervention between the study and control groups.This is in accordance with Tofighi, et al., (2012) who showed that it was a statistically significant upgrading in the study group for social functioning post intervention.In the same line, Khalife-Zadeh, Dorri and Shafiee (2015), showed that an insignificant difference was found between the study and control groups in all aspects except for social function favoring of the study group.On the other hand Mohammadi et al., (2006) & Antonakoudis, et al. (2006) who studied impact of rehabilitation on quality of life among patients with myocardial infarction, they reported that cardiac rehabilitation did not modify social domain of quality of life.

5.8
This study showed that, there was statistically significant difference after four months of intervention between the study and control groups regarding their mental health.This finding may be attributable to that improvement of physical health can decrease stressors and elevate patients' morale which in turn enhance their mental health.This finding is consistent with Sandvik, Seim, & Vanvik, (2000) who showed that cardiac rehabilitation resulted in development in all dimensions of life style modifications of the study group.This goes in the same line with an investigation by Grace, et al., (2008) showed that mental health and anxiety were enhanced post cardiac rehabilitation.Another systematic review indicated that cardiac rehabilitation can diminish psychological stress of coronary disorders Taylor, et al., (2010).In addition, Samartzis, et al., (2013) in their meta-analysis study, revealed that cardiac rehabilitation improved participants' mental and psychological health.
5.9 Concerning role limitations caused by emotional problems, this study indicated that, there was statistically significant difference after four months of intervention between the study and control groups.This can be interpreted as role limitations caused by CAD, which may influence patients' ability to work is frankly influence patients' capability to carry out tasks allied to daily life activities.This is in accordance with Rumsfeld, Magid, & Plomondon. (2003), who recommended that all post AMI patients have to participate in CR programs including group or team intervention.This approach increases the patient's confidence and well-being feeling.Chodosh, et al.( 2005),added that coronary syndrome may also result in emotional impaired functioning due to feelings associated with fears from death and losing families (i.e.inability to maintain family commitments and relationships) As well as Zwisler, et al (2008) revealed that health status was better post cardiac rehabilitation further more communication and work / leisure activities were also absolutely progressed.This progress is valuable to declare as it is a vital element of health status.

5.10
The finding of the current study reported a significant improvement in energy/fatigue and general health of the study group compared to the control group after four months from life-style modification intervention These results are compatible with the findings of Salameh, et al. (2012) who found an important advance in energy/fatigue and general health of coronary artery disease patients post cardiac rehabilitation program.Also Saeidi, et al. (2013), noted the same results.This is contradicted Yu et al. (2004) who reported that evaluation of general health dimension in two groups indicated no significant difference.Furthermore, Khalife-Zadeh, Dorri, and Shafiee (2015), noted that an important discrepancy was established between the study and control groups in all aspects of health status except for general health and social function in favor of the study group.

5.11
The total health status of coronary artery disease patients is significantly improved after four months from lifestyle modification intervention as evidenced by the results of the present study.An important possible explanation for the improvement of lifestyle modification intervention on health status of coronary artery disease patients in the present study is the significant improvement in the level of knowledge regarding CAD patients after the application of the educational intervention.This is congruent with the findings of prior studies (Meischke et al., 2000& Lunelli et al., 2009) that found a positive association between knowledge and compliance to healthy lifestyle.In the same line, Attarbashi-Moghadam et al., (2014) confirmed that a progress was recognized in total health status.According to three studies measured health status, three studies finding indicated verification for enhancement Devi, Powell, & Singh, (2014) & Maddison et al, (2014) & Varnfield et al, (2014).

Conclusion
The results of the current study concluded that life style modification intervention for coronary artery disease patients is an effective method that can improve their health status in the aspects of physical function, bodily pain, social function, role limitation due to physical or emotional problems and mental health.

Recommendations
Based upon results of the current study, the following recommendations were suggested: -Further research studies are necessary to verify the effect of intensified lifestyle modification intervention on cardiovascular risk factors, principally atherosclerosis and blood pressure.
-Patients` education should be held in continuous manner, because it is a fundamental part of their treatment.
-Level of patients` adherence to healthy lifestyle should be assessed over time.
-Cardiac rehabilitation centers should be established and encouraged.

Table 1 .
Socio-demographic characteristics of the studied patients with in the two group (n=92) Figure 1.Age distribution within the two groups Figure 2. Distribution of patients 'diagnosis within the two groupsTable 2. Mean score of life-style practices among the studied patients (n=92)

Table 3 .
Distribution of the two groups regarding physical function pre and post life style modification (n=92)

Table 5 .
Distribution of the two groups regarding mental health and role limitations caused by emotional problems pre and post life style modification (n=92)

Table 6 .
Distribution of the two groups regarding energy/fatigue and general health pre and post life style modification (n=92)