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Clinical Trials/NCT07669142
NCT07669142Active, not recruitingNot Applicable

THE EFFECT OF TELE-NURSING PRACTICES ON QUALITY OF LIFE AND CLINICAL OUTCOMES IN PATIENTS WITH PREDIALYSIS CHRONIC KIDNEY DISEASE

Istanbul University - Cerrahpasa1 site in 1 country66 target enrollmentStarted: May 15, 2026Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
66
Locations
1

Study Overview

Brief Summary

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 study will be conducted with patients diagnosed with stage 3A, 3B, or 4 chronic kidney disease who are followed in a nephrology outpatient clinic.

Participants will be assigned to intervention and control groups. Patients in the intervention group will receive a structured tele-nursing program including patient education, telephone or online follow-up, reminders, and counseling for disease management. Patients in the control group will continue to receive routine outpatient care.

Quality of life, medication adherence, self-care management, blood pressure, body weight, edema status, and laboratory parameters such as eGFR, creatinine, blood urea nitrogen, potassium, phosphorus, calcium, albumin, hemoglobin, and bicarbonate will be evaluated at baseline, 3 months, and 6 months. The study is expected to show whether tele-nursing support can improve quality of life, self-care behaviors, treatment adherence, and clinical outcomes in predialysis patients.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Being 18 years of age or older Having a diagnosis of stage 3A, 3B, or 4 chronic kidney disease Having an estimated glomerular filtration rate between 15 and 59 mL/min/1.73 m² Being followed in the nephrology outpatient clinic for at least 3 months Not receiving dialysis treatment Being able to communicate in Turkish Having access to a telephone or smart device suitable for tele-nursing follow-up Being able to participate in telephone, messaging, or online follow-up Voluntarily agreeing to participate in the study Providing informed consent

Exclusion Criteria

  • Having stage 1,2 and 5 chronic kidney disease Receiving hemodialysis or peritoneal dialysis treatment Having a history of acute kidney injury within the last 3 months Having a terminal illness Having severe cognitive impairment, psychiatric disorder, or communication problem that prevents participation in the study Having hearing, speech, or visual impairment that prevents effective tele-nursing communication Not having access to the required communication tools for remote follow-up Participating in another interventional study that may affect the outcomes of this research Refusing to participate in the study Withdrawing informed consent during the study period

Investigators

Sponsor
Istanbul University - Cerrahpasa
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ramazan Öztürk

NURSE

Samsun Education and Research Hospital

Study Sites (1)

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