Effect of an Educational Program on Attitudes and Behaviors toward Adherence to Therapeutic Regimen among Hemodialysis Patients: A Randomized Clinical Trials

Mohadeseh Setayesh¹, Mahlagha Dehghan², Alireza Malakotikhoh³, Mansooreh Azzizadeh forouzi⁴*

¹Medical Surgical Nursing, Nursing Research Center, Razi Faculty of Nursing and Midwifery,

Kerman University of Medical Sciences, Kerman, Iran.

²Nursing Research Center, Department of Critical Care Nursing, Razi Faculty of Nursing and Midwifery, Kerman University of Medical Sciences, Kerman, Iran.

³Nursing Research Center, Razi Faculty of Nursing and Midwifery,

Kerman University of Medical Sciences, Kerman, Iran.

⁴Nursing Research Center, Department of Medical Surgical Nursing, Razi Faculty of Nursing and Midwifery, Kerman University of Medical Sciences, Kerman, Iran.

*Corresponding Author Email: setayesh.89.m@gmail.com, forozy@gmail.com

ABSTRACT:

Background and Objective: Hemodialysis is the most common way to replace kidney function for patients with advanced kidney disease and it also needs their adherence to therapeutic regimen. Attitudes and behaviors of adherence to therapeutic regimen may have different consequences for patients and education can play an important role. The aim of this research was to study the effect of an educational program on attitudes and behaviors toward adherence to therapeutic regimen among hemodialysis patients. Methods: This study was a clinical trial, and the sample consisted of 60 patients (30 patients in each group) who assigned randomly into two groups (intervention or control). The data collection tools including demographic form, RAAQ (Renal Adherence Attitude Questionnaire) and RABQ (Renal Adherence Behavior Questionnaire), were completed with repeated measurements before, one month and three months after education. The SPSS_v19 and (Mean, standard deviation, paired t test and repeated measures test were used for data analysis. Level of significance was considered 0.05. Results: In the intervention group, the mean scores of attitudes toward adherence to the therapeutic regimen increased towards the good range (113.68 - 155) one and three months after the intervention 124.23 ± 10.57, 113.83 ± 10.22, respectively. Finding regarding behaviors to ward adherence toward adherence to the therapeutic regimen showed in the intervention group, the mean scores of behaviours in one and three months after the intervention were significantly higher than before the intervention (P < 0.001). there was no significant difference in laboratory tests before and after education. Conclusion: the education program was effective on attitudes and behaviors of adherence to therapeutic regimen but not on the laboratory indices. Therefore, it is advised to develop the education program for patients under hemodialysis continually and design the content in order to see this effect on laboratory indices as well.

KEYWORDS: Hemodialysis, Attitude, Adherence Behavior, Therapeutic Regimen, Education Program.

INTRODUCTION:

Chronic diseases are considered as the biggest problem in the health care system¹. Among the different types of diseases, the emphasis is on chronic renal failure (CRF)². More than 20 million adults worldwide suffer from kidney disease⁵, in Iran, 1,200 to 1,600 people develop this condition annually,⁶.

Based on glomerular filtration, CRF is divided into five stages which the fifth and final stage is called end-stage renal disease (ESRD)^4-7. Hemodialysis is the most common treatment⁹. Patients with ESRD, in addition to regular hemodialysis dependence, require dietary changes, fluid-intake restriction, and adherence to a long-term medication regimen².

Adherence is defined as the individual behavior toward receiving a therapeutic regimen, implementing lifestyle changes based on the recommendations of health care providers⁹. Adherence in patients undergoing hemodialysis depends on the four aspects of treatment, which include using prescribed medication, fluid-intake and dietary restrictions, and regular attendance at hemodialysis sessions⁸. Failure to follow the therapeutic regimen, increases hemodialysis complications and, as a result, decreases the quality of dialysis and leads to a shortage of bone density, congestive heart failure, and death^13-14.

The strategies of changing attitudes and behaviors toward adherence to therapeutic regimen should focus on knowledge in relating to dialysis, and the capacity of cultural values⁵. Educating is one of the tools for changing a person’s attitude and behavior through active participation¹⁷. In addition, patient education has many positive benefits, including reducing health care costs, increasing the quality of care, and helping the patient to gain more independence¹⁸. Therefore, raising and expanding an individual’s awareness and information about ways of promoting health eliminates false beliefs and has the most significant impact on creating a proper attitude and behavior¹⁶.

In a study by Deif et al. (2015) on patients with ESRD under maintenance hemodialysis, it was concluded that education has a positive effect on patients' adherence to the therapeutic regimen¹⁹. Also, in the study of Parvan et al. (2015) in Yazd, face-to-face education showed a significant positive increase in the attitude toward adherence to dietary and fluid-intake restrictions in hemodialysis patients¹⁷. Also, the result of Hasanzadeh et al. (2011) showed that Face-to-face education had a positive effect on attitudes toward diet in patients undergoing hemodialysis²⁰. As well, in a study in Tehran, Asgari et al. (2015) reported that education has a positive effect on improving adherence to treatment regimen and patients' attitudes in hemodialysis patients²¹. Furthermore, Zolfaghari et al. (2013) reported that the implementation of an educational program has been effective in reducing the patient's problems regarding laboratory indices and dietary restrictions, which indicates the positive effect of education²².

Considering the fact that one of the ways to increase or modify the attitudes and behaviors of adherence to therapeutic regimen in hemodialysis patients is education. This study aimed to investigate the effect of an educational program on attitudes and behaviors toward adherence to therapeutic regimen among hemodialysis patients.

MATERIALS AND METHODS:

Study Design and Setting

This study had a quasi-experimental design, which conducted on patients undergoing hemodialysis in Imam Reza Hospital, Sirjan, Iran.

Sample Size and Sampling:

All patients undergoing hemodialysis, formed the study population. A total of 89 patients were screened. By census, according to the inclusion criteria, 69 patients were invited to participate in the study. The study had nine samples dropped out due to death or transference to other wards. Patients were randomly allocated to intervention and control groups. Inclusion criteria were being 14 years old and more, at least six months of being under hemodialysis, and three times of hemodialysis per week for 3-4 hours. Exclusion criteria were being a kidney transplant candidate, being in the uremic phase of the disease.

Measures:

The data was collected through a 4-part researcher-made questionnaire. Demographic characteristics form including age, sex, marital status, education level, income, occupation, information related to the disease including the time of diagnosis, the cause of kidney failure, time of the first dialysis, the frequency of dialysis, the way of vascular access, and other diseases.

Researcher-made Therapeutic Regimen Adherence Attitude Questionnaire developed based on literature¹². This questionnaire contains 31 items with 5-point Likert scales (one = I agree very much, five = I strongly disagree). Its validity was evaluated by giving the questionnaire to 10 faculty members of KMU, and for the reliability, the questionnaire was provided to 30 target populations. Internal consistency was calculated using Cronbach's alpha (a = 0.78). The minimum and maximum score of the questionnaire was 31 and 155, respectively. The cut-off score of the questionnaire was 31 to 72.33 for weak, 72.34 to 113.67 for moderate, and 113.68 to 155 for good.

Researcher-made Therapeutic Regimen Adherence Behavior Questionnaire developed based on literature¹². This questionnaire contains 24 items with five-point Likert scales (one = Never, five = Always). Its validity was evaluated by giving the questionnaire to 10 faculty members of KMU, and for the reliability, the questionnaire was provided to 30 target populations. Internal consistency was calculated using Cronbach's alpha (a=0.7). The minimum and maximum score of the questionnaire was 24 and 120, respectively. The cut-off score of the questionnaire was 24 to 55.9 for weak, 56 to 87.9 for moderate, and 88 to 124 for good.

Laboratory test results form for Na, K, P, Alt, Ast, Alk, BUN, Cr, CBC, kt/V, and URR tests to measure dialysis adequacy. All tests were performed with a specific lab kit for all patients in Imam Reza Hospital, Sirjan.

Procedures:

The study was conducted in three stages of pre-intervention, intervention, and evaluation.

Pre-intervention stage:

This phase took a month, December of 2016. Initially, the researcher chose eligible subjects after her introduction and a brief description of the purpose of the study. Then, the patients, were randomly assigned to an intervention and a control group. Questionnaires were filled two hours after the start of dialysis by the researcher through an interview to avoid the discomfort associated with the onset of dialysis. In the intervention group, the needs and problems were gathered and based on the needs planning an educational program was prepared. Problems were how to care for vascular access paths such as fistula, graft, or catheter, and how to adhere to the recommended diet, drugs and fluids, and how to limit complications.

Intervention stage:

This phase took three weeks, January of 2017. The educational program was designed in 3 sessions, one session in each week in a period of one month, and each session was 30 to 45 minutes. The educational program was based on patients' knowledge, a therapeutic regimen which could reflect the adherence to the treatment, and laboratory information.

The educational program was about kidney function, types of kidney failure, causes, and manifestations of the disease, therapeutic regimen including food and fluid restriction, and adherence to drug orders. Educational sessions were face-to-face and held by the researcher. These sessions were during the dialysis, individually with the patient or with the company of patient’s caregiver. The first session was for getting acquaintance and explaining the study objectives. At the second session, the definition of kidney disease, the cause of kidney failure, hemodialysis apparatus, and the number of hemodialysis sessions per week was explained. For the third session, the definition of diet, permitted fluids and their permissible limits, and the correct use of medication were taught. The researcher provided the content of the educations in the form of a booklet to the patient and asked the patient to review for the next session. In the second and third sessions before the start of the new topic, the patient’s questions about the previous education were answered. In the control group, the routine educational procedure of the hospital was used.

Evaluation stage:

One month and three months after the completion of the educational program, the questionnaires were completed again.

Statistical Analysis:

Data were analyzed with the SPSS_v19.0. Descriptive statistics (frequency, percentage, mean, and standard deviation) were used to describe the characteristics of participants. The Chi-square and Fisher's exact test were used to assess the homogeneity of the two groups. The Kolmogorov-Smirnov test was used to examine the normal distribution of data. The repeated measure ANOVA (or their nonparametric equivalents) test was used to compare the mean scores within and between the control and intervention groups. The significance level was considered 0.05.

Ethical Consideration:

The study protocol was approved by the Ethics Committee of KMU, (IR.KMU.REC.1395.164), Iran Clinical Trial Center number (IRCT20170116031972N3). All samples were given detailed descriptions of the method and objectives of the study. Verbal informed consent was taken from patients. Participants were assured that all information was confidential, and their participation was optional.

RESULTS:

The mean age in the intervention group was 53.53 ± 13.26, and in the control group 58.53 ± 13.43. In both groups, most participants were married, illiterate, unemployed, and homemakers with a monthly income between 10,000,000 to 20,000,000 Rials (237.50 to 475.00 USD at the time of the study). There was no significant difference between the intervention and control groups in terms of age, gender, marital status, education, and income and in terms of these variables the two groups were similar. (Table 1)

Table 1: Demographic characteristics of the intervention and control groups

Groups Variables	Intervention Group		Control Group		Statistical Analysis	P-value
Groups Variables	Mean	SD	Mean	SD	Statistical Analysis	P-value
Age	53.53	13.26	58.53	13.43	t = 1.45	0.15
Variables	Frequency	Percent	Frequency	Percent	Statistical Analysis	P-value
Gender
Female	11	36.7	15	50	c² = 1.09	0.3
Male	19	63.3	15	50	c² = 1.09	0.3
Marital Status
Single	4	13.4	1	3.3	Fisher exact test = 3.6	0.16
Married	25	83.3	25	83.3
Widow/ Divorced	1	3.3	4	13.4
Education
Illiterate	11	36.7	16	53.3	c² = 2.08	0.56
Reading and Writing	5	16.7	5	16.7
Under Diploma	7	23.3	4	13.3
Diploma or Higher	7	23.3	5	16.7

t = Independent t-test

c² = Chi-squared test

Table 2: Comparison of attitudes toward adherence to therapeutic regimen between intervention and control groups

Group Time	Intervention Group		Control Group		Repeated Measures ANOVA	P value
	Mean	SD	Mean	SD
Before Intervention	103.63	11.97	102	9.58	F = 26.47	< 0.001
One Month after Intervention	124.23	10.57	100.53	10.74
Three Month after Intervention	113.83	10.22	99.5	10.9
Greenhouse-Geisser	F = 73.48		F = 6.49
P value	< 0.001		0.001

Table 3: Comparison of behaviors toward adherence to therapeutic regimen between intervention and control groups

Group Time	Intervention Group		Control Group		Repeated Measures ANOVA	P-value
	Mean	SD	Mean	SD
Before Intervention	90.63	10.33	89.27	9.82	F = 13.89	< 0.001
One Month after Intervention	103.43	7.61	89.1	9.3
Three Month after Intervention	97.97	7.49	88.5	9.14
Greenhouse-Geisser	F = 119.17		F = 0.95
P value	< 0.001		0.38

According to Table 3, in the intervention group, the mean scores of behaviours in one and three months after the intervention were significantly higher than before the intervention (P<0.001). Although the mean score in three months after the intervention was significantly less than one month after the intervention, it was still significantly higher than the mean score before the intervention. Also, in the control group, there was no significant difference in the mean scores of behaviours before, one, and three months after the intervention (P = 0.38). Also, there was a significant difference between the two intervention and control groups in one and three months after the intervention in terms of the mean scores of behaviours (P < 0.001). (Table 4)

DISCUSSION:

The results of this study showed that patients’ attitudes toward adherence to therapeutic regimen were in the moderate range in both intervention and control groups before the intervention. In the intervention group, one and three months after the education, the mean scores had a significant increase towards the good range. Although in the control group they remained in the moderate range, their reduction in the moderate range was significant. The findings of a study by Hasanzadeh et al. (2011) conducted on hemodialysis patients indicated an increase in attitude related to diet and fluids adherence in the face-to-face education group at the end of second and fourth weeks after the training compared to the time before the intervention²⁰. Also, Asgari et al.’s study (2015) on hemodialysis patients showed that both family-centered and patient-centered education methods were significantly effective on attitude toward adherence to diet and fluid restriction, and there was a significant difference between the times before and after the intervention²¹. Despite the difference in the type of education in these two mentioned studies, their results are in line with the results of the present study. In addition to studies on hemodialysis patients, other studies by Merghati et al. (2017) and Shabbidar and Fathi (2007) conducted on other chronic diseases such as heart failure and type 2 diabetes illustrate the positive effect of education on the attitudes of patients with a chronic disease toward their disease and healthy lifestyle^23-24.

The literature review and the results of the present study indicate that education with any methods could have a positive effect on patients' attitude²¹, but the effect of education reduces during the time. Also, education can be effective if it is presented in a variety of ways and a continuous manner, and repetition and practice can always make learning more sustainable. Since chronic illness stays with patients until the end of their life, health systems should have a plan in the field of continuous education for these patients; so that patients could match their lifestyle according to educations and thus have a better quality of life.

According to the results, patients’ behaviors toward adherence to therapeutic regimen was in the good range in both intervention and control groups before the intervention and one and three months after. In the intervention group, the mean scores of behaviors in one and three months after the intervention were significantly higher than before the intervention. Also, there was a significant difference between the two intervention and control groups in one and three months after the intervention in terms of the mean scores of behaviors. In a study by Asgari et al. (2015) on hemodialysis patients, family-centered education method was significantly effective on behaviors toward adherence to diet and fluid restriction²¹. Barnett et al. (2008) in a study on hemodialysis patients revealed that the face-to-face education had a positive effect on fluid compliance and patients’ compliance increased from 47% to 71.5%²⁵. Zolfaghari et al. (2013) also reported that cognitive-behavioral intervention had a significant effect on adherence to dietary and fluid-intake restrictions in hemodialysis patients²². A study by Liu et al. (2016) reported that self-care behaviors included body mass and diet control, drug regimen, physical activity, proper care of the fistula, and psychosocial behaviors in the intervention group had significantly increased after receiving a knowledge-attitude-behavior education program²⁶.

The results of studies in the literature review are consisted with the result of the present study which confirm the effect of education on behaviors toward adherence to therapeutic regimen. In general, it can be concluded that the current education program for dialysis patients is not effective on patients’ behaviors toward adherence to therapeutic regimen. However, different methods of educating by experts can have a positive effect on hemodialysis patients’ behaviors.

The patients’ lack of cooperation in receiving and applying the educator’s instructions and patients’ physical and emotional well-being at some sessions were the main limitations of this study. In order to overcome these limitations, training sessions were held at the patient's desired time considering their physical and mental conditions.

CONCLUSION:

The results confirm the positive effect of the educational program on attitudes and behaviors toward adherence to therapeutic regimen in hemodialysis patients. This study suggests further investigation of the effects of other educational methods and continuous education. Given that education is the main pillar of nursing care, in the absence of adequate education, patients do not understand the importance of adherence to therapeutic regimen and consequently suffer from the complications and consequences of the disease. Therefore, it is recommended that research be conducted on the effectiveness of the educational program and its continuity in chronic patients, especially patients undergoing hemodialysis in different societies.

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Received on 06.09.2020 Modified on 24.10.2020

Asian J. Nursing Education and Research. 2021; 11(2):163-168.

DOI: 10.5958/2349-2996.2021.00041.0