INTRODUCTION

Chronic kidney disease (CKD) constitutes a major global public health burden and is projected to become the fifth most prevalent chronic condition worldwide by 2040 [1]. National surveillance data in Iran reflect this growing trend; Shahbazi et al. [2] reported an increase in CKD cases from 97 300 in 1990 to 315 500 in 2019. Among the available renal replacement therapies for patients with end-stage renal disease (ESRD), hemodialysis is the most frequently utilized and serves as a maintenance intervention intended to approximate normal physiologic function as closely as possible [3]. In Iran, nearly 50% of patients with ESRD receive hemodialysis, which imposes a considerable financial burden on families and national healthcare systems [4]. Patients undergoing hemodialysis experience better outcomes when they remain hopeful and maintain a good quality of life [5]. According to the World Health Organization, quality of life refers to individuals’ perceptions of their position in life within the context of their cultural environment, value systems, personal goals, expectations, standards, and concerns [6]. Shaw et al. [7] reported that 58.7% of CKD patients undergoing hemodialysis experience fair to poor quality of life. Evidence suggests that factors such as self-care and treatment adherence are critical determinants that promote quality of life and support favorable clinical outcomes, including reduced morbidity, lower mortality rates, and fewer dialysis-related complications [8,9]. Within the hemodialysis population, treatment adherence represents a complex, multifaceted construct characterized by a process-oriented approach, active engagement with prescribed therapies, a patient-centered orientation, and sustained commitment to ongoing care [10]. Three separate studies have documented overall non-adherence among individuals on hemodialysis, with prevalence estimates ranging from 22.2% to 51.5%. Across these studies, inadequate self-care consistently emerges as the most commonly reported and modifiable contributor [11–13].

Self-care involves intentional, informed, and voluntary actions undertaken by individuals to sustain life, maintain health, and promote optimal well-being through awareness and the ability to care for themselves [14]. One of the most comprehensive approaches to self-care is Orem’s self-care model, which emphasizes that individuals should assume personal responsibility for their own health and well-being [15].

Research Gap and Significance of the Study

While numerous studies conducted in Iran and other countries have explored treatment adherence, self-care behaviors, and quality of life among patients undergoing hemodialysis, no research to date has concurrently examined the impact of an educational intervention rooted in Orem’s self-care model on all 3 variables within this population. Therefore, given the importance of this topic and the limited number of studies addressing it, further research is recommended across different countries to support knowledge translation in patient education. Accordingly, the present study was designed to assess the effects of an educational program based on Orem’s self-care model on treatment adherence, self-care behaviors, and quality of life among hemodialysis patients in southern Iran.

METHODS

Study Design

This study employed a single-blind randomized controlled trial (RCT) design. Participants were randomly assigned to either an intervention group or a control group. Data were collected between April 2023 and August 2023 at 2 university- affiliated teaching hospitals located in southern Iran. To ensure methodological rigor and transparency, the study adhered to the Consolidated Standards of Reporting Trials (CONSORT) guidelines, an internationally recognized framework for the conduct and reporting of randomized controlled trials [16].

Inclusion and Exclusion Criteria

To qualify for inclusion in the study, participants were required to meet several criteria: they had to be capable of verbal communication, have been undergoing hemodialysis for at least 6 months, have no acute or chronic psychological or cognitive disorders, and be under 70 years of age. Exclusion criteria included deterioration of the patient’s condition, missing more than 2 sessions of the educational intervention, and instances of participant death or voluntary withdrawal at any point during the study.

Sample Size

Based on the findings reported by Naroie et al. [17], and using a 5% significance level, the mean quality of life scores before and after the intervention were 46.90±4.36 and 56.65±4.98, respectively. Assuming a mean difference of 9 points between the 2 groups (d=9), a confidence level of 95% (α=0.05), and a statistical power of 90% (β=0.1), the minimum required sample size was calculated to be 74 participants. However, to compensate for potential attrition and ensure the robustness of statistical analyses, the final sample size was increased to 120 participants. The following formula was used to estimate the minimum sample size [17]:

n=s12+s22d2(Z1-α/2+Z1-β)2

Sampling Procedure and Randomization

Participant selection involved a systematic, multi-stage process. Initially, a comprehensive list of 135 patients receiving hemodialysis was compiled. Each individual was subsequently screened for compliance with the eligibility criteria. During this stage, 15 patients were excluded due to ineligibility or unwillingness to participate. The remaining 120 eligible participants proceeded to the randomization phase.

Simple Randomization

The 120 eligible participants were selected through a random sampling process using a simple randomization program designed to ensure fairness and minimize bias. The 120 hemodialysis patients were then randomly allocated into 2 groups (Figure 1): an intervention group (n=60) and a control group (n=60). A receptacle was filled with 120 cards, 60 marked with the letter A and 60 with the letter B, for allocation purposes. These envelopes were prepared by a research assistant who was not involved in enrollment or data collection. Each participant who met the inclusion criteria was asked to select a card. Patients who picked an A were assigned to the intervention group, whereas those who picked a B were assigned to the control group. Participants were unable to see the letter on the card until it was drawn from the box.

Data Collection Instruments

Data collection was conducted using 3 standardized, psychometrically validated instruments, described below.

Demographic and clinical information form

This form was designed to capture baseline demographic and clinical characteristics, including age, sex, marital status, educational attainment, employment status, duration of illness, and any family history of chronic kidney disease.

End-stage renal disease adherence questionnaire

The end-stage renal disease adherence questionnaire (ESRD-AQ), developed by Kim et al. [18] in 2010, assesses adherence to treatment among patients with advanced renal disease and comprises 41 items. The total adherence score is calculated by summing the scores across 5 domains. Each domain is scored on a scale ranging from 50 points to 300 points, yielding a total possible score between 150 and 1200. Higher scores reflect greater adherence to the prescribed therapeutic regimen. The Persian version of the questionnaire was translated and validated by Khalili et al. [19] in 2014, demonstrating internal consistency with a Cronbach’s alpha of 0.88. In this study, the Cronbach’s α value was 0.84, representing a high level of reliability for the scale.

Kidney disease quality of life instrument

The Kidney Disease Quality of Life Instrument (KDQOL-36) instrument, developed by Hays et al. [20] in 1994, is widely recognized as a robust and frequently used disease-specific tool for assessing quality of life in individuals with CKD. It evaluates 2 primary dimensions—physical health and mental health—each comprising several subdomains. Each subdomain is scored on a scale from 0 to 100, with higher scores, especially those exceeding 50, indicating better quality of life. In a study conducted by Yekaninejad et al. [21] in Iran, the instrument demonstrated satisfactory internal consistency, with a Cronbach’s α of 0.79. In this study, the Cronbach’s α value was 0.85, which is considered a high level of reliability for the scale.

Self-care behavior questionnaire

Developed in Iran by Sajjadi et al. [22] in 2008, the self-care behavior questionnaire evaluates self-care practices among patients with CKD. It consists of 29 items grouped into 5 domains: nutrition and dietary adherence (7 items), skin and fistula care (10 items), activity and fatigue management (3 items), sleep and rest (4 items), and emotional well-being with a focus on depression (5 items). Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (always), resulting in a total score ranging from 0 to 116. Higher scores indicate more desirable and effective self-care behaviors. Reliability was confirmed via a test–retest method over a 1-week interval, producing a correlation coefficient of r=0.87. In this study, the Cronbach’s α value was 0.89, representing a high level of reliability for the scale.

Educational intervention process

Prior to initiating the intervention, an educational package grounded in Orem’s self-care model was developed. These instructional materials were prepared in accordance with the self-care guidelines issued by the Treatment Deputy of Iran’s Ministry of Health and Medical Education and were informed by authoritative scientific and specialized nursing literature. To ensure educational content validity, the materials were reviewed by a panel of experts comprising 5 nephrologists, 5 nursing faculty members, and 3 clinical education supervisors. Patients in the intervention group participated in weekly educational sessions conducted over 4 consecutive weeks, with each session lasting approximately 2 hours. Some patients underwent hemodialysis on even days (Saturday, Monday, and Wednesday), whereas others attended on odd days (Sunday, Tuesday, and Thursday). As a result, the patients were unable to communicate with one another, and no information was exchanged between them. The educational program was conducted in the hospital conference hall with patient coordination and with the permission of the hospital manager. Educational topics were presented through lectures, group discussions, and PowerPoint presentations. Training sessions were facilitated by the corresponding author (MB) and the first author (SR).

Education Sessions

The first session focused on foundational knowledge, including the pathophysiology of kidney disease, its signs and symptoms, common complications, exacerbating and mitigating factors, and the overall impact on patients’ lives. The second session covered dietary guidelines specific to dialysis patients, fluid restriction and management, skin and fistula care, and pharmacological treatment. The third session addressed topics such as body weight monitoring, social interaction, sexual health, physical activity, travel, recreation, and psychological well-being. The final session was devoted to pain management, the importance of regular medical visits and adherence to dialysis schedules, treatment compliance, and strategies for infection prevention and control. Each session concluded with time allocated for questions, group discussion, and assessment of patient understanding. To reinforce the educational content, follow-up telephone calls were made by the first author (SR) to provide ongoing consultation and address any patient concerns. These calls were intended to answer patients’ questions, encourage adherence to the program, and support improvements in treatment adherence, self-care behaviors, and quality of life. Additionally, educational booklets and pamphlets were distributed at the conclusion of the intervention to strengthen learning. Throughout the study period, the control group received only the standard educational services routinely provided by ward nurses through face-to-face interactions and institutional pamphlets. However, upon completion of the study, the educational package was provided to all control group participants to ensure ethical parity. Questionnaires were administered to both groups at 3 time points: prior to the intervention, immediately following its conclusion, and 3 months post-intervention.

Statistical Analysis

Statistical analyses were conducted using SPSS version 23.0 (IBM Corp., Armonk, NY, USA). The Kolmogorov–Smirnov test was used to assess the normality of continuous variables. Baseline demographic and clinical characteristics were compared between groups using either the independent-samples t-test or the Mann–Whitney U-test, depending on data distribution. Furthermore, repeated measures analysis of variance (RM-ANOVA) was employed to examine both within-group and between-group changes in mean scores related to treatment adherence, self-care behaviors, and quality of life over time. The p-values<0.05 were considered statistically significant.

Ethics Statement

Written informed consent was obtained from all participants. Participants were also explicitly informed about the measures implemented to ensure anonymity and confidentiality of their data. All requisite ethical approvals were obtained prior to data collection. The study protocol was approved by the institutional ethics committee (approval code: IR.FUMS.REC.1400.110) and registered with the Iranian Registry of Clinical Trials (IRCT 20190917044802N2).

RESULTS

The study involved 120 hemodialysis patients, divided into a control group (n=60) and an intervention group (n=60). The mean ages of participants in the intervention and control groups were 58.8±11.7 years and 57.9±11.4 years, respectively. The results of the chi-square test and independent-samples t-test showed that the 2 groups did not differ statistically significantly in terms of demographic variables (p=0.881; Table 1). At baseline, quality of life scores were similar between groups. However, the intervention group demonstrated significantly higher quality of life scores than the control group immediately after the intervention and at 3 months, post-intervention (p<0.001; Table 2). Repeated-measures analysis of variance (ANOVA) indicated a significant upward trend in quality of life scores over time in the intervention group compared with the control group (p<0.001; Table 2). At baseline, treatment adherence scores were similar between groups. However, the intervention group exhibited significantly higher treatment adherence scores than the control group immediately after the intervention and at 3 months post-intervention (p<0.001; Table 2). Repeated-measures ANOVA revealed a significant upward trend in treatment adherence scores over time in the intervention group compared with the control group (p<0.001; Table 2). At baseline, self-care behaviors scores were also similar between groups. However, the intervention group showed significantly higher self-care behaviors scores than the control group immediately after the intervention and at 3 months, post-intervention (p<0.001; Table 2). Furthermore, repeated measures analysis of variance (RM-ANOVA) demonstrated a significant upward trend in self-care behaviors scores over time in the intervention group compared with the control group (p<0.001; Table 2).

DISCUSSION

This study sought to evaluate the impact of an educational intervention grounded in Orem’s self-care model on self-care behaviors, quality of life, and treatment adherence among hemodialysis patients in Fars Province, southern Iran. The findings revealed that the intervention led to a statistically significant enhancement in self-care behavior scores within the intervention group compared to the control group. These outcomes are consistent with the findings of Santana et al. [23], whose results indicated that patients who actively engaged in self-care—particularly those adhering to dietary and fluid restrictions and managing vascular access—benefited substantially from education and guidance provided by healthcare professionals. These findings meaningfully parallel those of the present study, in which structured educational sessions based on Orem’s model significantly improved self-care behavior scores.

The study conducted by Simmons [24], which applied Orem’s self-care theory in nursing practice within hemodialysis settings, also supports our findings. Simmons explored the utility of Orem’s model in enabling nurses to assess self-care deficits and design tailored interventions aimed at improving patients’ capacity to manage their treatment regimens. The study highlighted that nursing interventions informed by Orem’s theory—including patient education and support—enhanced adherence to essential aspects of self-care, such as dietary regulation and medication compliance. These findings correspond closely with our results, in which the intervention group demonstrated a significant increase in self-care behavior scores, likely due to targeted educational strategies that enabled patients to address self-care limitations. Simmons [24]’s emphasis on the central role of nurses in facilitating self-care aligns with the structured educational approach implemented in our intervention and further substantiates the effectiveness of Orem’s model in improving self-care outcomes among individuals undergoing hemodialysis. Similarly, Choi et al. [25], in their study found that a program designed to boost self-efficacy—grounded in Orem’s model—significantly improved self-care behaviors. The intervention sought to strengthen patients’ confidence in managing their illness, thereby enhancing adherence to dietary and fluid restrictions. These findings are in strong agreement with those of the current study.

Moreover, a quasi-randomized controlled trial conducted by Wu et al. [26], although not explicitly grounded in Orem’s model, reported outcomes that parallel those of our study. The intervention group, which received structured health education, demonstrated notable improvements in self-management behaviors—including problem-solving and executive aspects of self-care—relative to the control group. These findings indicate that structured educational interventions, similar in function to the Orem-based training implemented in our study, can significantly enhance self-care behaviors among patients receiving hemodialysis [26]. Based on the present findings, the educational program designed in accordance with Orem’s self-care model resulted in a statistically significant difference in post-intervention quality of life scores between the intervention and control groups. Similarly, Naroie et al. [17], in a quasi-experimental study, investigated the effect of an Orem-based self-care intervention on quality of life in hemodialysis patients and demonstrated significant improvements—particularly in physical and psychological domains—among individuals in the intervention group. These results corroborate those of the present study and affirm that Orem’s model, by addressing specific self-care deficits associated with hemodialysis, effectively enhances patients’ quality of life. Although most research supports the beneficial effects of Orem-based interventions on quality of life, certain studies have reported less consistent outcomes or identified barriers to achieving uniform improvements. For example, Heidarzadeh et al. [27], in an observational study examining the relationship between self-care ability and quality of life in hemodialysis patients, found a positive correlation between these 2 variables despite the absence of a structured Orem-based intervention. While their findings suggest that higher self-care ability is associated with better quality of life, the lack of an educational component prevents direct assessment of causality.

Despite the favorable outcomes observed in this study, several limitations should be acknowledged. The study was conducted exclusively among patients undergoing hemodialysis, which may restrict the generalizability of the findings to other patient populations. Further research is needed to assess the applicability of these results across diverse clinical contexts. The duration of the intervention was relatively short, and its long-term effects remain unknown. Extended follow-up through longitudinal studies is needed to evaluate the durability of the intervention’s impact. Consequently, to confirm or challenge the present findings, future studies employing larger sample sizes and longer intervention periods are warranted. Because the data collection relied on self-reported measures, participants’ responses may not have been entirely accurate, and social desirability or acquiescence bias may have been present.

Notwithstanding the aforementioned limitations, the findings of this study are noteworthy for several reasons. To date, no randomized controlled trial has specifically evaluated the effects of an educational intervention based on Orem’s self-care model on self-care behaviors, treatment adherence, and quality of life in hemodialysis patients. The existing literature has predominantly consisted of descriptive or quasi-experimental studies, with most interventional research focusing on isolated variables.

Implications in Nursing Clinical Practice and Education

The results of this trial carry implications for nursing education, clinical practice, research, and health policy. It is recommended that contemporary educational methodologies—particularly those grounded in well-established nursing theories such as Orem’s model—be systematically integrated into nursing curricula. Additionally, structured training workshops emphasizing the clinical utility and outcomes of Orem-based self-care education should be incorporated into hospital-based educational programs. Healthcare institutions are encouraged to allocate protected time for nurses to participate in such sessions, free from routine workload demands, to ensure active engagement and meaningful participation. This study represents the first clinical trial to evaluate the impact of an Orem-based educational program on treatment adherence, self-care behaviors, and quality of life in patients undergoing hemodialysis. As such, its findings may serve as a foundation for subsequent research in this field. The results contribute to a more nuanced understanding of the practical application of nursing theories in patient education and hold the potential to enhance the quality of care delivered in dialysis settings. Moreover, these outcomes may inform nursing administrators and policymakers about the effectiveness of theory-driven educational strategies and encourage the adoption of similar approaches for patients with other chronic conditions.

Data Availability

Notes

Conflict of Interest

The authors have no conflicts of interest associated with the material presented in this paper.

Funding

None.

Acknowledgements

None.

Author Contributions

Conceptualization: Rezaei S, Bijani M, Fereidouni Z. Data curation: Rezaei S. Formal analysis: Dehghan A. Funding acquisition: None. Methodology: Rezaei S, Fereidouni Z. Project administration: Rezaei S, Bijani M. Visualization: Dehghan A. Writing – original draft: Rezaei S, Bijani M, Dehghan A, Fereidouni Z. Writing – review & editing: Bijani M.

Figure 1

CONSORT (Consolidated Standards of Reporting Trials) flow diagram.

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Figure & Data

References

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