Effect of educational intervention on knowledge and level of adherence among hemodialysis patients – A randomized control Trial

Purpose: The purpose of the study was to assess the impact of an educational intervention on the level of knowledge, and adherence to the treatment regimen among haemodialysis (HD) patients as well as to describe the association between these variables. Methods: In this randomised control study, 160 HD patients at a HD centre of a 2030 bed tertiary teaching hospital in Southern India were randomly assigned into intervention (N = 80, received education and a booklet) and control (N = 80, received standard care ) groups. Knowledge, adherence were measured pre- and post-intervention using a validated questionnaire for knowledge and ESRDAQ – End stage renal disease questionnaire for level of adherence. The statistical analysis of the data was performed with the help of the Statistical Program SPSS version 19.0. The statistical signicance level was set up at 0.05. Results: The increase of knowledge on disease management and adherence in the intervention group was signicantly higher compared to the control group. There was no signicant correlation between knowledge and adherence. Adherence improved for all the domains ie dialysis attendance, episode of shortening, adherence to medication, uid restriction and dietary restriction. Adherence to Fluid and dietary restriction were statistically signicant


Introduction
Patients on dialysis experience assimilating complex treatment regimens, that includes monitoring blood glucose, intra dialytic weight gain, bp monitoring, bill burden, physical activity, investigation routine and adhering to treatment regimens. Patient education is not only a critical mechanism through which patients can have their questions, concerns, and needs regarding kidney disease care addressed, but it is also a crucial pathway to ensuring that patients can be taught to engage in self-management. 1 Non-adherence among HD patients includes the following, according to the National Kidney Foundation-Kidney Disease Outcomes Quality Initiative (NKF-KDOQI) (a) skipping or reducing the HD session; (b) consuming excessive amounts of potassium and phosphorus-containing beverages and foods; and (c) failing to take medication as prescribed. 2 Nonadherence to dialysis treatment has been generally reported at rates between 8.5% and 22.1% worldwide 3 . According to Dialysis Outcomes and Practice Patterns Study (DOPPS), it is estimated that 9.7% of US patients skipped ≥ 1 HD sessions (for over a month), while the rate for both Japanese and European patients was 0.6% 4 . The success of treatment depends to a large extent on the adherence to the strictly recommended therapeutic regimen. In order to improve adherence patient's knowledge on disease management should be improved. Some studies have shown that patient knowledge on disease and treatment is associated with increased level of adherence 5,6,7 Need for Education Program and rationale for the current study 1. Patients' understanding of haemodialysis and end-stage renal disease (ESRD) is essential for effective self-management and patient outcomes. There is a need for evidence and trials on the effect of therapeutic education among dialysis patients 2. The literature review con rms the bene ts on pre dialysis education on patient outcomes in terms of delayed dialysis initiation, reduce all-cause mortality, decrease hospitalization rates, increase use of selfcare-based dialysis modalities, extend dialysis survival, and improve overall quality of life. Similarly post dilayis therapeutic intrevntions of a focused nature demonstrated positive effects. evidence on use of multidisciplinary care lacks certainty and majorly constitutes observational studies and non-randomised control trials 3. Patient education is a vital component of care, according to national programmes and CKD care standards. Furthermore, many CKD patients express a desire for CKD education. Hence there is a need to study the effect of an educational intervention on patient outcomes using randomised trial. 4. Patient education barriers may have rami cations for patient education implementation. These factors must be researched and addressed during the implementation of education in order for it to be effective. 5. Barriers in patient education may affect the implementation of education. Therefore there is a need to identify barriers in order to improve implementation 6. Most patients have many questions they would like to ask but either don't know how to project their questions to the health care providers. At the time of admission, the patient there is a information overload and takes a considerable amount of time to imbibe information, therefore, a structured educational program can be bene cial.
7. Non-adherence to treatment is an increasing problem for patients with CKD and it has not been extensively studied in patients with CKD. Hence, the present study was carried out to assess the knowledge on disease management, adherence practice, factors affecting adherence, quality of life and effect of a structured educational intervention on these outcomes 8. The question of whether multidisciplinary educational intervention can affect end stage renal disease therapeutic outcomes, and if so, can a nephrologist and nurse su cient to meet the aim, has yet to be solved in the dialysis population.

Design And Sample
A randomised control trial conducted from June 2017 to December 2020 was performed among 160 HD patients at a 2030 bed tertiary teaching hospital using block randomisation, allocation concealment and outcomes assessment was blinded. The criteria for selecting the sample were as follows: (i) HD program two times a week (ii) above 18 years of age (iii) ability to write, read and understand the local language Patients with cognitive and psychologically differently abled and limited self-care were excluded. The study population was randomly divided into two groups: The intervention group (received an educational intervention and a booklet) and the control group (standard care at the dialysis centre ). The educational session for each patient was administered for 6 months with reinforcement and addressing patients queries and patients were followed up for one year. The beeline data demographics were collected with a proforma, knowledge on disease management was assessed with a self-administered validated questionnaire and for measurement of level of adherence, ESRD-AQ questionnaire was used Ethical clearance (441/2015) was obtained from the Institutional Ethics Committee of Kasturba Hospital, MAHE, Manipal and registered under Clinical trial registry of India CTRI Registration number: Trial REF/2017/12/016258. As per the ethical guidelines, participant information sheet (PIS) and informed consent (IC) for parent participants. The data collection forms had indirect identi ers. The informed consent forms were separated from the data sheets to maintain con dentiality. Information from the study was kept con dential. The data was stored in le cabinets and was accessible only to the core research team. Following data entry, the data records were securely stored on a password-protected device. The data will be stored for a period of three years following the study and then destroyed.

Ethical considerations
Ethical clearance (441/2015) was obtained from the Institutional Ethics Committee of Kasturba Hospital, MAHE, Manipal.
Phase 01: Inputs from the KDOQI guidelines and expert opinion on its adaptation and modi cation and cultural adaptation to current population in the study was used to design the educational module. A judgmental validity was done. Judges who are professionals in the elds of nephrology, nutrition, pharmacy, and physical therapy evaluated this intervention guide. The intervention guide was forwarded to the professionals listed above for feedback. The PI discussed to the specialists the aim and goals of this stage. They were told to read the intervention guide attentively and report any challenges they encountered while testing it, as well as to look for the following: ambiguity, such as ambiguous or badly phrased products, double-barrelled remarks, or jargons. For each item, the percentages of entire agreement, agreement with small modi cations, agreement with large changes, and total disagreement were calculated. Any issue that received 70% or more total disagreement from the experts was removed from the teaching material. All the specialists were alerted to the elements that were in agreement with small and substantial adjustments. Many minor adjustments were xed with their permission, and some important alterations were altered once a majority of experts agreed to that particular change.
The educational materials were written in English, and the rst step was to convert the guide into Kannada. During the translation process, the back translation approach was applied. Two independent language specialists translated the intervention guide into Kannada. They were told to keep as much of the original structure and text as feasible. Variations were discussed with the two specialists, and changes were agreed upon. Other two English-Tamil language experts back converted the accepted Kannada version of the intervention guide into English. For consistency, the back translated version was compared to the original intervention guide. Following consultations with the experienced translators, any discrepancies were xed once more. The rst section pursues general information about patients' ESRD and RRT-related history (5 items), and the remaining four sections ask about treatment adherence to HD treatment (14 items), medications (9 items), uid restrictions (10 items), and diet recommendations (8 items). These four nal sections directly measure adherence behaviours (14, 17, 18, 26, 31, and 46), and patients' knowledge and perceptions about treatment (11, 12, 22, 23, 32, 33, 41, and 42). Responses to the ESRD-AQ utilize a combination of Likert scales and multiple choice, as well as "yes/no" answer format. A score of less than 1100 was mild compliance, 1100 -1149 moderate compliance, 1150 and above as high compliance and 1200 as full compliance. The mild and moderate scores were combined to form low category of adherence and high and full compliance were combined to form the high category of adherence.

Statistical Analysis
A mixed ANOVA (repeated measure) is performed to check is there any signi cance difference in the average knowledge/adherence across different time points as well as between intervention group and control group. A non-parametric approach of mixed ANOVA is performed using the R package "nparLD" to check is there any signi cance deference in the average adherence/QoL across different time points as well as between intervention group and control group as data violated the normality assumptions As the outcome variable 'Knowledge' was not normally distributed, quantile regression was used to determine the factors related to this outcome. As the outcome variable 'Adherence' was not normally distributed, quantile regression was used to determine the factors related to this outcome. P < 0.05 is considered as statistically signi cant and analysis is performed using SPSS software. The sample characteristics of the study population are described in Table 01. Participants in the intervention group and control group constituted i.e., male (80%) in intervention and (75.3%) in control group. A higher proportion of participants in both groups had less than Secondary Education (52.2%, 43.8%) and were largely unemployed. Vintage of more than a year was comparably higher in both groups. Aetiology-wise, hypertension predominated among those in the intervention group (41.3%) while in the control group, diabetes mellitus predominated (56.3%). All participants in the intervention group had comorbidities, while 7 (8.75%) in the control group did not. There was statistically signi cant difference between the groups in the aetiology of diseases (p=0.001) and presence of comorbidities (0.002). Regarding the mode of payment for treatment, cash payments were higher in both groups. Mean scores domain wise adherence before and after intervention

Results
This study showed that the educational intervention can improve knowledge (Table 02 and Figure 01) and adherence (Table 03 , Figure 02 ), by way of improving information , reinforcement and limiting misconceptions about the disease. Prior to the intervention, both groups had similar levels of knowledge. After the intervention, while there was a signi cant increase for both groups, the increase in the intervention group was signi cantly higher, resulting in a signi cantly higher score compared to the control group (Table 02). Underline that educational programmes can help people with chronic conditions in a variety of ways (physical, mental, self-care, clinical decision-making). The relevance of a patientcentered approach is emphasised in these studies. The patient is treated as a partner in this approach, and is fully educated about his or her health and participates in therapeutic decision-making. 8,9 While there are many studies that have shown improvement in the comprehensive knowledge levels of knowledge. There are also research studies on education interventions that have improved targeted knowledge among the dialysis population like knowledge on vascular access, nutrition, biochemical parameters. Souza et al investigated how effective a teaching intervention was at promoting vascular self care and the results showed that the teaching intervention greatly enhanced knowledge regarding serum phosphorus and no effect on calcium . Reddy et al 2009 found that one month of nutrition education enhanced understanding of phosphate and phosphate binders but had no effect on serum phosphate levels in the group. Therefore targeted educational interventions or comprehensive educational interventions largely have an impact on the patients knowledge of disease management with parallel reinforcement and even while knowledge improves it may not translate to change in or improvement in outcomes measures . 10,11,12,13 There was an improvement in all the domains of adherence in the intervention group and statistically signi cant difference was observed for adherence to uid and dietary restriction. (Table 04) However, adherence to HD attendance, episode of shortening, duration of shortening and medication adherence were not statistically signi cant. There was a decrease in medication, uid and dietary adherence in control group . The ndings imply that there is an improvement in the adherence level following the intervention. While other studies on patient compliance have also reported an improvement, there are studies which have reported contrasting results .In the study conducted by Elain and colleagues (2003) use of educational intervention resulted in signi cant increase in the Knowledge scores in intervention group (P<0.001) during the course of the intervention. 14 However, it did not produce any behaviour change among the patients and the compliance to uid restrictions did not improve .
Similarly wells Jr (JR., 2011) educational intervention to improve knowledge and medical adherence in African Americans on dialysis Witnessed no signi cant difference between pre and post intervention in relation to medical adherence however the paired sample teachers revealed higher knowledge scores in the post test group compared to the pretest group . . 15 (Nooriani Narjes, 2019) after the trial, the intervention group exhibited substantial gains in scores on the nutrition knowledge exam, perceived vulnerability, perceived severity, perceived barriers, perceived advantages and self e cacy. Energy protein high biological value protein carbohydrate, fat, cholesterol, vitamins , calcium phosphorus and potassium consumption did not differ signi cantly between the 2 groups. The health belief structure model was also used in this investigation. However there was number signi cant difference between the two groups in terms of calories protein, carbohydrate, fat, cholesterol intake . 16 Several studies reported an improved overall adherence among HD patients . (Zhianfar L, 2020) Iranian patients were given a multi modal educational intervention, and after one month, the interventions group adherence school were much higher than baseline levels. The intervention group participants had statistically signi cant changes in means codes in all sub skills of ESRD-AQ. the intervention involves showing videos to the patient and family members to emphasize the signi cance of adhering to the therapeutic regimen, as well as cognitive behavioral therapy group meetings for patients and telephone based counselling. Conciliation with beard support the encounter with educational videos for three consecutive sessions for half an hour following the start of dialysis therapy kept the patients table and convenient for the third session, and experience methodologist was invited to answer the patients concerns and dilemmas. The practicing nurse was also subjected to educational video tracks to familiarise them with the content in order to answer patients probable questions 17 .
In an investigation by Hala I. Abo Deif (2017)