EFFECTS OF TELENURSING IN PREDIALYSIS PATIENTS (Telenurse-CKD)

Chronic kidney disease is a progressive and long-term health condition characterized by a gradual decline in kidney function and an increased risk of metabolic, cardiovascular, nutritional, psychosocial, and functional problems. The predialysis period, particularly stages 3A, 3B, and 4 chronic kidney disease, represents a critical phase in which appropriate education, lifestyle regulation, medication adherence, symptom monitoring, and regular follow-up may contribute to better disease management and delay the progression of renal dysfunction. During this period, patients are expected to follow complex recommendations related to nutrition, fluid intake, blood pressure control, medication use, physical activity, avoidance of nephrotoxic agents, symptom recognition, and timely health-seeking behaviors. However, many patients have difficulties in understanding and maintaining these behaviors in daily life. This may negatively affect quality of life, treatment adherence, self-care management, and clinical outcomes.

Predialysis patients often experience a high symptom burden, uncertainty about disease progression, fear of dialysis, limitations in daily activities, and reduced quality of life. In addition, changes in laboratory parameters such as estimated glomerular filtration rate, serum creatinine, blood urea nitrogen, potassium, phosphorus, calcium, sodium, albumin, hemoglobin, bicarbonate, and glycemic indicators may require continuous monitoring and individualized education. Patient education provided only during routine outpatient visits may not be sufficient for long-term behavioral change, especially because outpatient visits are usually short, clinic workload is high, and patients may forget or misunderstand the information provided. For this reason, structured, continuous, and nurse-led follow-up models are needed in the predialysis period.

Tele-nursing is a remote nursing care approach that uses telephone calls, messaging applications, video communication, digital education materials, reminders, and regular monitoring to support patients outside the hospital setting. Tele-nursing practices may increase access to nursing care, strengthen communication between patients and healthcare professionals, support medication adherence and self-care behaviors, and facilitate early identification of warning signs. In chronic disease management, tele-health and tele-nursing interventions have been increasingly used to improve patient education, treatment adherence, symptom control, and quality of life. In chronic kidney disease, remote follow-up may be particularly valuable because patients require long-term monitoring, repeated education, lifestyle modification, and timely referral when clinical deterioration occurs.

This study aims to evaluate the effect of tele-nursing practices on quality of life and clinical outcomes in predialysis patients with chronic kidney disease. The main objective of the study is to determine whether a structured tele-nursing program improves kidney disease-related quality of life compared with routine outpatient care. The secondary objectives are to evaluate the effects of the tele-nursing program on medication adherence, self-care management, blood pressure, body weight, edema status, and selected laboratory parameters. The study also aims to provide evidence regarding the feasibility and potential usefulness of nurse-led remote follow-up in patients who have not yet started dialysis treatment.

This study is planned as a randomized controlled experimental study with intervention and control groups and repeated measurements. The study population will consist of adult predialysis patients with stage 3A, 3B, or 4 chronic kidney disease who are followed in a nephrology outpatient clinic. Eligible participants will be assigned to either the tele-nursing intervention group or the control group. Data will be collected at three time points: baseline, the third month, and the sixth month. The study is expected to be conducted over a six-month follow-up period for each participant.

Participants will be included in the study if they are 18 years of age or older, have a diagnosis of stage 3A, 3B, or 4 chronic kidney disease, are followed in the nephrology outpatient clinic for at least three months, have not started dialysis treatment, are able to communicate in Turkish, have access to a telephone or smart device suitable for remote follow-up, and provide informed consent to participate in the study. Chronic kidney disease stages will be defined according to estimated glomerular filtration rate values. Stage 3A will include patients with an estimated glomerular filtration rate of 45-59 mL/min/1.73 m², stage 3B will include patients with an estimated glomerular filtration rate of 30-44 mL/min/1.73 m², and stage 4 will include patients with an estimated glomerular filtration rate of 15-29 mL/min/1.73 m².

Patients will be excluded if they have stage 5 chronic kidney disease, are receiving hemodialysis or peritoneal dialysis, have a history of acute kidney injury within the last three months, have a terminal illness, have severe cognitive impairment or a communication problem that prevents participation, do not have access to the required communication tools for tele-nursing follow-up, or are participating in another interventional study that may affect the outcomes of this research. Patients who withdraw consent, start dialysis during the study period, develop a clinical condition that prevents continued participation, or cannot be reached despite repeated contact attempts may be considered withdrawn from the study according to the study protocol.

The estimated sample will consist of predialysis patients who meet the inclusion criteria and agree to participate. Participants will be allocated to the intervention and control groups. The planned sample size will be determined according to power analysis, taking into account the expected effect size, type I error probability, statistical power, and possible losses during follow-up. In order to compensate for possible attrition, the number of participants planned to be recruited may be higher than the minimum number required for analysis. The study will aim to maintain adequate statistical power by considering potential withdrawals during the six-month follow-up period.

Randomization will be performed after eligibility assessment and informed consent. Participants will first be stratified according to chronic kidney disease stage, including stage 3A, stage 3B, and stage 4. Since disease stage may affect quality of life, clinical outcomes, laboratory values, symptom burden, and risk of progression, stratification by stage is intended to ensure a balanced distribution of disease severity between the intervention and control groups. Within each chronic kidney disease stage, participants will also be considered according to sex in order to support balance between female and male participants. After stratification, participants will be assigned to the intervention or control group using a computer-generated random allocation sequence. The randomization process will be conducted before the initiation of the intervention. The allocation process will be planned to minimize selection bias and to ensure that participants in different stages of chronic kidney disease are proportionally represented in both study arms.

Because of the nature of the intervention, blinding of participants and the researcher delivering the tele-nursing intervention will not be feasible. Participants in the intervention group will know that they are receiving tele-nursing support, and participants in the control group will continue routine outpatient care. However, standardized data collection forms and predefined measurement time points will be used to reduce measurement bias. Clinical and laboratory data will be obtained from routine clinical follow-up records and patient assessments where appropriate.

The intervention group will receive a structured tele-nursing program in addition to routine nephrology outpatient follow-up. The tele-nursing program will include planned patient education, telephone or online follow-up, reminders, counseling, symptom monitoring, and support for self-care management. The intervention will be delivered by the researcher using telephone calls, messaging applications, or online communication methods depending on patient accessibility and preference. The aim of the program is to support patients in understanding chronic kidney disease, applying recommended self-care behaviors, recognizing warning symptoms, improving treatment adherence, and maintaining regular follow-up.

The educational content will be structured according to the needs of predialysis patients with chronic kidney disease. The program will include information about kidney functions, chronic kidney disease stages, the meaning of predialysis care, the importance of regular nephrology follow-up, blood pressure control, blood glucose control when applicable, medication adherence, safe medication use, avoidance of nephrotoxic drugs, nutrition, fluid management, physical activity, weight monitoring, edema monitoring, symptom management, skin care, sleep and fatigue management, and warning signs requiring medical consultation. The content will be adapted to the clinical characteristics of stage 3A, stage 3B, and stage 4 patients. Patients will be educated about the importance of understanding their estimated glomerular filtration rate, serum creatinine, potassium, phosphorus, albumin, hemoglobin, bicarbonate, and other relevant laboratory values.

The tele-nursing education program will be organized in weekly themes during the initial intervention period. In the first week, patients will receive general information about chronic kidney disease, the predialysis period, kidney functions, disease progression, and the importance of self-management. Subsequent educational sessions will focus on nutrition in chronic kidney disease, including salt restriction, potassium and phosphorus awareness, protein intake according to medical recommendations, reading food labels, avoiding processed foods, and safe food choices. Fluid management will be discussed according to the patient's clinical condition, edema status, blood pressure, and physician recommendations. Patients will be encouraged to monitor body weight and edema and to report sudden changes.

Medication adherence will be another major component of the intervention. Patients will be educated about taking medications as prescribed, not discontinuing medications without medical advice, avoiding non-prescribed painkillers and herbal products that may harm kidney function, and informing healthcare professionals about all medications and supplements used. The intervention will also include reminders and counseling to support adherence to antihypertensive drugs, antidiabetic medications if applicable, phosphate binders if prescribed, bicarbonate therapy if prescribed, erythropoiesis-stimulating agents or iron therapy if prescribed, and other treatments related to chronic kidney disease management.

Physical activity and daily living recommendations will be included in the program. Patients will be encouraged to engage in appropriate physical activity according to their age, comorbidities, functional capacity, and physician recommendations. The education will emphasize avoiding prolonged inactivity, maintaining daily movement, recognizing symptoms such as chest pain, severe shortness of breath, dizziness, or excessive fatigue during activity, and seeking medical advice when necessary. The program will also address fatigue management, sleep hygiene, and strategies to maintain independence in daily life.

Symptom management will be addressed throughout the tele-nursing follow-up. Patients will be asked about symptoms such as fatigue, nausea, loss of appetite, itching, muscle cramps, sleep problems, shortness of breath, chest pain, swelling in the legs or face, changes in urine output, uncontrolled blood pressure, dizziness, and signs of infection. Patients will be educated about which symptoms require routine consultation and which symptoms require urgent medical evaluation. Tele-nursing follow-up will not replace physician care, emergency services, or routine nephrology visits; rather, it will support patients in recognizing problems earlier and seeking appropriate care.

The intervention group will also receive periodic reminders. These reminders may include messages or calls related to medication use, blood pressure monitoring, weight monitoring, edema assessment, outpatient appointment attendance, laboratory test follow-up, dietary recommendations, and self-care behaviors. Educational materials may be shared digitally or verbally reinforced during telephone contacts. The frequency and content of follow-up contacts will be structured according to the study protocol, while also allowing individualized counseling based on patient needs.

The control group will continue to receive routine nephrology outpatient care. Routine care may include physician evaluation, laboratory follow-up, medication regulation, and standard verbal recommendations given during outpatient visits. Participants in the control group will not receive the structured tele-nursing program during the study period. However, they will continue to access all standard healthcare services available in the outpatient clinic. Data will be collected from the control group at the same time points as the intervention group: baseline, third month, and sixth month.

The primary outcome of the study will be the change in kidney disease-related quality of life. Quality of life will be assessed using the Kidney Disease Quality of Life-36 scale. This scale evaluates domains related to the burden of kidney disease, symptoms and problems of kidney disease, effects of kidney disease on daily life, and physical and mental health components. Measurements will be performed at baseline, at three months, and at six months. The comparison of changes over time between the intervention and control groups will show whether the tele-nursing intervention has an effect on quality of life.

Secondary outcomes will include medication adherence, self-care management, blood pressure, body weight, edema status, and laboratory parameters. Medication adherence will be assessed using a medication adherence scale appropriate for chronic disease management. Self-care management will be assessed using a scale that evaluates self-care behaviors in chronic diseases. Blood pressure measurements will include systolic and diastolic blood pressure. Body weight and edema status will be monitored as indicators of fluid balance and clinical status. Laboratory parameters will include estimated glomerular filtration rate, serum creatinine, blood urea nitrogen, potassium, phosphorus, calcium, sodium, albumin, hemoglobin, bicarbonate, and HbA1c when applicable. These parameters are clinically relevant in predialysis chronic kidney disease because they reflect renal function, metabolic balance, nutritional status, anemia, electrolyte balance, acid-base status, and comorbidity control.

The study will also collect sociodemographic and clinical characteristics of participants. These may include age, sex, marital status, education level, employment status, duration of chronic kidney disease, chronic kidney disease stage, comorbidities such as diabetes mellitus and hypertension, medication use, smoking status, body weight, blood pressure, and relevant laboratory values. These data will be used to describe the study sample and to examine whether the intervention and control groups are comparable at baseline.

Data analysis will be performed using appropriate statistical methods. Descriptive statistics will be used to summarize participant characteristics. Continuous variables may be presented as mean, standard deviation, median, minimum, and maximum values depending on distribution. Categorical variables may be presented as frequency and percentage. Baseline characteristics of the intervention and control groups will be compared to evaluate group similarity. The normality of continuous variables will be assessed before selecting statistical tests. Between-group comparisons, within-group changes over time, and group-by-time interactions will be examined using appropriate parametric or non-parametric tests. Repeated measurement analyses may be used to evaluate changes from baseline to the third and sixth months. The level of statistical significance will be determined according to the study protocol.

The expected result of this study is that patients receiving tele-nursing support will have greater improvement in quality of life compared with patients receiving routine care alone. It is also expected that the tele-nursing intervention will improve medication adherence and self-care management by providing continuous education, reminders, and individualized counseling. Patients in the intervention group may become more aware of their disease stage, laboratory values, dietary restrictions, medication safety, symptom monitoring, and warning signs. As a result, they may be better able to participate actively in their own disease management.

It is also expected that the intervention may contribute to better clinical monitoring. Improvements may be observed in blood pressure control, weight and edema follow-up, and awareness of laboratory parameters. Although tele-nursing may not directly reverse chronic kidney disease, it may support behaviors that help stabilize clinical status, reduce avoidable risks, and promote timely communication with healthcare professionals. The intervention may also reduce uncertainty and anxiety related to disease management by providing patients with regular nursing support and reliable information.

This study may contribute to the literature in several ways. First, it focuses specifically on the predialysis period, which is a critical but sometimes under-supported stage of chronic kidney disease care. Many studies in kidney disease focus on dialysis patients, while fewer intervention studies address the needs of stage 3A, stage 3B, and stage 4 patients before dialysis initiation. Second, the study evaluates a nurse-led tele-nursing model that combines education, follow-up, reminders, counseling, symptom monitoring, and clinical outcome assessment. This comprehensive approach may provide practical evidence for integrating nursing care into remote chronic kidney disease management.

Third, the study includes both patient-reported outcomes and objective clinical outcomes. Quality of life, medication adherence, and self-care management reflect the patient-centered effects of the intervention, while blood pressure, body weight, edema status, and laboratory parameters provide clinically meaningful data. By evaluating these outcomes together, the study may help clarify whether tele-nursing affects not only knowledge and behavior but also measurable clinical indicators.

Fourth, the intervention content is designed according to the needs of different predialysis stages. Stage 3A, stage 3B, and stage 4 patients may have different levels of risk, symptom burden, laboratory abnormalities, and educational needs. By including patients from these stages and considering stage-based stratification during randomization, the study aims to produce more balanced and clinically relevant results. This may support the development of stage-specific patient education and follow-up models in chronic kidney disease.

Fifth, the study may provide evidence for the role of nurses in preventing or slowing the deterioration of patient outcomes during the predialysis period. Nurses are in a key position to educate patients, support self-care, monitor symptoms, reinforce treatment adherence, and coordinate care. Tele-nursing can extend this role beyond the outpatient clinic and may help maintain continuity of care between visits. If the intervention is effective, it may serve as a model for nurse-led remote follow-up programs in nephrology outpatient settings.

The findings of this study may have practical implications for healthcare services. A structured tele-nursing program may be a feasible and cost-conscious approach for supporting predialysis patients, especially those who have difficulty attending frequent face-to-face education sessions or who need repeated reinforcement of self-care recommendations. Remote follow-up may also help identify problems earlier, encourage patients to attend scheduled appointments, and strengthen communication between patients and the healthcare team. In settings with high outpatient workload, tele-nursing may provide an organized method for continuing patient education and monitoring outside routine clinic visits.

Ethical principles will be followed throughout the study. Participants will be informed about the purpose, procedures, potential benefits, and voluntary nature of the study. Written or documented informed consent will be obtained before participation. Participants will be informed that they may withdraw from the study at any time without any negative effect on their routine medical care. Personal data and health information will be kept confidential and used only for research purposes. The intervention will not replace medical treatment or physician recommendations. Patients will be advised to contact healthcare professionals or emergency services when urgent symptoms occur.

In conclusion, this study is designed to evaluate whether a structured tele-nursing program can improve quality of life, medication adherence, self-care management, and clinical outcomes in predialysis patients with chronic kidney disease. By combining remote education, follow-up, reminders, counseling, and clinical monitoring, the study aims to support patients during a critical period before dialysis. The results are expected to contribute to the development of nurse-led tele-health models in nephrology care and to provide evidence for improving the management of patients with stage 3A, stage 3B, and stage 4 chronic kidney disease.