The Effect of Training Given to Coronary Artery Patients on Disease Management
Phase: NA
Conditions: Patient Empowerment, Coronary Artery Disease
Sponsor: Kilis 7 Aralik University

Disease Management for Coronary Artery Patients  
Clinical Trial Register Number: NCT04556006 
Ethics Committee Approval Date: June 6, 2018 
Document Date: June 17, 2021 
Study Protocol  
Setting and samples  
This study was planned as a single-blind randomised controlled trial with pretest–posttest and 
followed the guidelines of the Consolidated Standards of Reporting Trials (CONSORT) 
statement. The population of the study was composed of the patients diagnosed with coronary 
artery disease (CAD) staying in cardiology clinic of a State Hospital in Southeast Anatolia 
Region, Turkey (March, 2019–March, 2020). The sample size of the study was determined 
according to the result of the power analysis. The minimum sample size required for the 
difference to be significant in terms of compliance questionnaire (CQ) scores in patients who 
received and did not receive training was determined to be at least 26 patients in each group 
(α = .05, 1- β = .80, effect size = .80). The patients, who were aged between 18 and 79, were 
diagnosed with CAD for at least 2 months, had no hearing and vision problem, had no 
perception and expression deficiency, were not diagnosed with any psychiatric dis-ease and 
were voluntary to participate in the study, were included in the study. A total of 74 patients 
meeting the inclusion criteria (37 in the intervention group and 37 in the control group) were 
included in the sample. However, the study was terminated within the scope of COVID-19 
pandemic measures that started abroad and affected Turkey too. The sample of the study 
consisted of 58 patients (30 in the intervention group and 28 in the control group) whose data 
were completely collected until the pandemic period.  

Data collection tools  
The data of the participants were collected by using personal information form, 
anthropometric measurements, Framingham risk score and compliance questionnaire.  
Personal information form  
It was prepared by the researchers by reviewing the related literatures. In this form, there were 
questions investigating the patients’ socio- demographic characteristics, anthropometric 
measurements and CAD risk factors.  
Compliance questionnaire  
Compliance Questionnaire (CQ) is a form allowing to investigate 11 different areas such as 
the use of medication causing maladaptation in disease management in individuals with 
chronic illnesses, diet, weight loss, limiting physical activity, exercise, coping with stress, 
alcohol use, smoking, sexual activity problems, caffeine intake and working/job life. It was 
developed by Marston in 1969. In the form allowing Likert-type evaluation, the participant is 
expected to select one of the options 0 (never), 1 (very rarely), 2 (sometimes), 3 (most of the 
time) or 4 (always) while expressing his/her adherence level for each adaptation area. The 
scores corresponding to the given expression are summed, and CQ score for each participant 
is determined. The maximum score is 44. High score signifies an increase in the adherence 
level to the disease. In the validity and reliability study, internal consistency of CQ was 
determined as Cronbach's Alpha value .56 and intraclass correlation coefficient value .69. In 
this study, the internal consistency Cronbach's Alpha value of the responses given to CQ was 
found as .701.  
Anthropometric measurements  

Anthropometric measurements (height, weight, waist circumference and hip circumference) 
were performed by the researcher when the patients had thin clothes that would not change 
their weights. In repeated measurements, attention was paid to ensure that the clothes were in 
similar weights. For example, the patient, who wore a thin pyjama in the first measurement, 
was asked to change his clothes if he/she wore a thick sweater in the second measurement. In 
addition, care also given during the weight measurements that the patients were hungry and 
did not need defecation/micturition. Weight measurements were made using a digital scale 
showing decimal values and measuring weights in kilograms. While measuring the height, 
waist circumference and hip circumference, a plastic tape measure divided by 0.1 cm intervals 
without stretching feature was used. In the measurements made with tape measure, the 
patients were asked to stand upright position and leave their abdomen freely by not pulling in. 
The obtained data were recorded in the related form.  
Randomisation  
The patients informed at the beginning of the study were randomised into the intervention and 
control groups. Randomisation was performed using random numbers produced in the 
computer (SPSS version 20 software) by a statistician who had no contact with the 
participants and did not participate in the study. All patients participating in the study were 
blinded during the randomisation process but the researchers were not blinded due to the 
nature of the intervention research. The patients in the control group continued to receive 
standard care by being unaware that they were in a training programme about treatment 
adherence in CAD. On the other hand, the patients in the intervention group were invited to 
participate in a training programme on treatment adherence in CAD.  
Data collection  

The data collection process of the study was carried out in two stages using data collection 
tools.  
First stage  
Personal Information Form and Compliance Questionnaire were applied to all patients in both 
groups. After anthropometric measurements, FR score was determined. The data collection 
forms were filled with the patients using face-to-face interview technique. The data collection 
process lasted for approximately 10–15 min. After the data collection, the patients in the 
intervention group were trained. The patients in the control group were given only standard 
care protocol by clinicians. During study, no training programme was given to the patients in 
the control group by researcher but they received a ‘Coronary Artery Disease Adherence 
Guide’ end of study.  
Second stage  
12 weeks after the first interview, the patients were interviewed again face-to-face interview 
technique and the forms and measurements applied initially were repeated. The content of the 
collected data was the same as first stage.  
Standard care protocol  
In the standard care protocol provided by clinicians, no printed/visual material was provided 
to the patients, only verbal information was given. In this protocol, only unstructured basic 
information about the disease, treatment and risk factors is given to the patients. However, 
behavioural changes in patients are not followed. Standard care protocol was applied by 
clinicians to all patients participating in the study. In addition, coronary artery disease training 
programme was applied to the patients in the intervention group by first researcher.  

The training programme is not only more structured training than the standard care 
programme but also includes patient follow-up at certain periods. Thus, the effect of the given 
education and follow-up on patient behaviour is monitored. A training guide named 
‘Coronary Artery Disease Adherence Guide’ was given to the patients in the intervention 
group. This training guide includes information about basic information about CAD, risk 
factors (hypertension, diabetes, obesity, smoking, alcohol, stress and sedentary life), 
adherence with treatment (drug use and clinical check-up appointments) and healthy lifestyle 
behaviours (exercise and weight control). The training guide was prepared by the researchers 
by bringing guides prepared by national and international organisations about the subject and 
the related literature together. While preparing the training guide, attention was paid to use 
plain language and 16 font size so that patients could easily read and understand. It was 
prepared in a comprehensive enough way to meet the patients’ need for information about 
disease, treatment process, risk factors and coping mechanisms. In addition, the guide was put 
into final form by obtaining opinions of different experts from fields of internal medicine 
nursing, psychiatric nursing, physiotherapy and rehabilitation, nutrition and dietetics for 
independent assessment. The training programme was applied to patients in intervention 
group by the first author who also works as an academic nurse. After the nurse explained the 
information in the training guide for each patient as a standard, the question / answer part 
started. During the training, patients’ relatives were allowed to be in the room if they wanted 
and patients/their relatives were encouraged to ask questions. The questions asked were 
answered in accordance with the explanations in the training guide. Exercises and relaxation 
movements that the patients had difficulty understanding were demonstrated by the 
researcher. Afterwards, the patient was asked to repeat these movements. During the study, 
the researcher examined the patients’ behaviours, encouraging the correction of the wrong 
ones and the continuation of the correct ones. The contact information of the patients was 

obtained and the contact information of the researcher was also given to the patients. In order 
to consolidate the information given, the training guide was given to the patients in the 
intervention group. After the training, the patients in the intervention group were contacted 
again in the 2nd week by using face-to-face interview and in the 4th– 8th and 12th weeks by 
phone calls. Training in the first meeting took approximately 30– 40 min, each of the next 
four interviews took approximately 10– 15 min. During these telephone interviews, the 
questions of the patients, if any, were answered and the problems they faced regarding the 
treatment adherence were tried to be solved. In the last interview, an appointment day was 
determined to meet face-to- face at home, workplaces or hospital according to the preferences 
of the patients. During the appointment day, personal information form and CQ were filled 
again. Last meeting took approximately 20– 30 min. The patients in the control group 
received only the standard care protocol provided by the clinicians. After the collection of 
post-test data, the content of the training was also explained to these patients and the study 
was completed by giving them the training guide.  
Data analysis  
The data were investigated using IBM SPSS Statistic 20.0 program. As the descriptive 
statistics, frequency, percentage, mean and standard deviation were used. In the adherence 
control of continuous variables to normal distribution, Shapiro–Wilk test was used. While 
independent samples t test was used in the comparison of two independent groups having 
normal distribution, Mann–Whitney u test was used for the non-normal distributed data. In the 
determination of the correlation between categorical variables, Chi-Square test was used. 
Since measurements were repeated twice (initial–12thweeks), p- values for continuous 
variables are obtained from general linear model repeated measures analysis. The group was 
used as the between-subject factor, and time as the within-subject factor. Mean values with 
their 95% confidence intervals and p- values for group, time and group × time interaction 

were reported. In this way, type I error rate within- and between-groups variation was 
controlled. Effect size (Cohen's d) was used for measure of the magnitude of the experimental 
effect. It was suggested that d = 0.2 be considered a ‘small’ effect size, 0.5 represents a 
‘medium’ effect size and 0.8 a ‘large’ effect size. The larger the effect size the stronger the 
relationship between two variables. Statistical significance level was accepted as p < .05.