NCT07506980

Nurse Led Intervention on Self Care Adherence and Quality of Life

Effect of Nurse-led Intervention on Self-care Adherence and Quality of Life Among Patients Undergoing Hemodialysis.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: Kathmandu University School of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

Background: Hemodialysis is the most common treatment modality in patients with chronic kidney disease. The majority of people with dialysis have a below-average quality of life. Adherence to diet and fluid intake, engagement in physical activity, and feeling blue and anxious will all affect quality of life. Nurses play a key role in patient education and behavioral support. Nurse-led interventions, especially educational programs (laptop-based), combined with reminders and educational materials, may improve patients' knowledge, adherence to treatment, and improvement in quality of life. Methodology The study will adopt the quantitative research design .The study will be conducted in a single private tertiary care center. First, the day and shift were randomized, and participants belonging to the particular day and shift will be considered as Group A and Group B. After this, the eligibility criteria will be assessed, and the baseline assessment will be done. A convenient sampling technique will be used to select the study sample. The sample will be a minimum of 56 in each arm. Therefore, altogether there will be at least 112 participants. One group will receive nurse-led interventions (Group A), and the control group (Group B) will receive usual routine care. Nurse-led intervention comprises 4 laptop-based educational and counseling sessions, 4-6 telephone reminders, and the distribution of the booklet on self-care. All four sessions will be conducted by the specialist nurse or nurse with at least one year of working experience in a dialysis unit. Each session will be conducted once every one to two weeks. The primary outcome will be self-care adherence. The self-care adherence will be measured by direct assessment of clinical parameters (interdialytic weight gain) of adherence and subjectively through face-to-face interviews. Patients' medical records will be reviewed. The secondary outcome will be the quality of life score. An independent assessor (enumerator) will measure the outcome at T1 and T2, which will be done at 2 months (T1) and 6 months (T2) from the baseline. Analysis will be done through the Stata software version 14. Descriptive statistics like frequency, percentage, mean±sd, median, inter quartile range are based on the nature of the data. Similarly, inferential statistics such t t-test and linear regression analysis will be used to find out the difference in mean score between two groups. The findings will be considered statistically significant at level p\<0.05 at 95% CI. The strength of this study will be the inclusion of both clinical and subjective parameters of adherence and assessment of quality of life. Use of a qualitative approach in explaining the factors, like appropriateness of the education and counselling session, along with the facilitators and barriers to adherence, will further help to modify the interventions. If the method is found to be effective, this will be an effective measure to improve quality of life cost-effectively. This can be continued on a regular basis in the same center and can be utilized in others, too.

Detailed description

Introduction Chronic kidney disease (CKD) is an abnormality in the structure and function of the kidney that has been present for at least three months and has health implications. It is classified based on the cause, glomerular filtration rate, and albuminuria rate.1 The worldwide prevalence of CKD is 10%, with more than 800 million people affected by it.2 The nationwide population-based survey of Nepal showed that the overall prevalence of CKD is 6.6%, with approximately 1,895,080 people affected by it.3 People with CKD cannot filter out urine; as a result, the patient has retention of metabolic wastes and increased metabolic acidosis. People with CKD develop signs and symptoms of uremia, like shortness of breath, leg swelling, muscle cramps, heartburn, itching, sexual dysfunction, poor sleep, pain, drowsiness, joint pain, reduced mobility, and fatigue. These changes in the body result in peripheral edema, hypertension, reduced exercise capacity, and the development of cardiovascular disease. 1, 4 The treatment options available for kidney disease are lifestyle changes, medicines, dialysis, and kidney transplantation. In dialysis, there are peritoneal dialysis and hemodialysis.1, 4 Worldwide, an estimated 4.9 million people are receiving hemodialysis treatment.5 In America, out of 808,000 patients with kidney failures, about 556,000 people are undergoing hemodialysis treatment.6 In Nepal, approximately 3,775 people receive hemodialysis treatment from 60 centers.7 Hemodialysis, which uses an artificial kidney, removes extra fluids, toxins, and solutes.8 Kidney Disease Outcome Quality Initiatives (K/DOQI) recommends thrice-weekly maintenance hemodialysis with a minimum of three hours per session.9 Most of the patients in Nepal undergo twice-weekly in-center hemodialysis sessions. 7, 10 People undergoing hemodialysis have multiple problems like fluid and electrolyte imbalance, volume overload, swollen ankles, shortness of breath, tiredness, and difficulty sleeping.11 Hemodialysis patients must follow their dialysis schedule and comply with dietary recommendations and fluid and salt restrictions. Besides this, there is a fear of morbidity and mortality in these groups of patients. 12 Mental health issues like anxiety and depression are highly prevalent in people with hemodialysis, at 49.6% and 55%, respectively.13 The prevalence of anxiety ranges from 27-69 % and depression from 11% -78% in the context of Nepal.14-19 The Presence of these issues affects various aspects of physical, mental, emotional, social, and family domains of quality of life and vice versa. 13 The dialysis and the presence of multiple symptoms reduce the person's ability to work, and these patients need to adhere to treatment.20 Self-care adherence is the specific recommended behaviors a person initiates and maintains to improve and sustain their health. These are the combination of activities that include controlling weight, adherence to prescribed medications, eating a healthy diet, altering fluid and salt intake, engaging in adequate physical activity, participating in exercise, ventilating feelings, and alcohol and smoking cessation.21,22 In dialysis patients, objective measures of self-care adherence can be assessed by evaluating interdialytic weight changes, blood pressure, serum phosphate and sodium levels, and functional independence.23 The improvement in self-care adherence score correlated with the improvement in quality of life score. 24 Research suggests that the pooled prevalence of worldwide dietary non-adherence ranges from 47% to 73%, and fluid non-adherence ranges from 50% to 71%.25 In Nepal, adherence to fluid and diet was 49% and 43%, respectively.26 The patient on dialysis has to restrict their salt intake to less than 2 gm /day and fluid intake to less than 500 ml plus previous output to maintain their inter-dialytic weight gain.4 Inter-dialytic weight gain is an important assessment tool for salt and fluid intake and an essential parameter of salt and fluid adherence. The weight should be less than 1.5 kg between two hemodialysis sessions, and there should be no more than a 1 kg weight gain per day between sessions.27 The inter-dialytic weight gain percentage should be lower than 4 to 4.5 % of dry weight. Inter-dialytic weight gain in kilograms is the difference between pre-dialysis and post-dialysis weights. The inter-dialytic weight gain in percentage is the difference between pre- and post-dialysis weights divided by the dry weight in kg, multiplied by 100.28 Physical activity is another essential part of self-care adherence.23 A large survey across 12 countries found that 44% had never been involved in any exercise.29 A study from Nepal showed that only 42.5% were involved in some physical activity, whereas 57.5% were not involved in any kind of physical activity.30 The participants in another study on knowledge of self-care management scored the lowest on the knowledge level of exercise (47.27±20.59 out of 100).31 Exercise not only prevents complications but also contributes to better health. It is the leading factor in improving the performance status and quality of life of people undergoing hemodialysis. 32, 33 Established guidelines recommend that hemodialysis patients perform 150 minutes of moderate-intensity activity or 75 minutes of vigorous activity per week. These can be done during or outside dialysis.34, 35 According to the Centers for Disease Control and Prevention, health-related quality of life is "an individual's or group's self-perception of their physical and mental health over time." It is a measure of a person's being.36 Patients undergoing hemodialysis experience multiple symptoms and lifestyle changes, and because of this, their everyday health-related quality of life (HRQOL) is affected. HRQOL is a key outcome, serving as an indicator of the impact of health status on quality of life and as a powerful predictor of the relative risk of death and hospitalization. 37 Several studies have shown that hemodialysis patients experience a decreased quality of life. 38-42 Nursing-led interventions are a care delivery model in which a nurse initially assesses, evaluates, and, based on these findings, plans her intervention or seeks a multidisciplinary/interdisciplinary effort to address the patient's problems.43 The KDIGO guideline 2024 recommends that people with chronic kidney disease receive care from a multidisciplinary care team. This care should include individualized education and counselling on lifestyle modification, including diet, exercise, smoking cessation, medication, and psychological support.1 A systematic review and meta-analysis on the role of educational/cognitive, counseling/behavioral interventions led to a significant reduction in interdialytic weight gain (mean difference in weight- 0.15 kg) in the intervention group compared to no intervention. Psychological interventions were associated with a reduction in interdialytic weight gain of 0.26 kg compared with the intervention group.44 Other studies have failed to demonstrate significant differences in objective self-care adherence parameters between groups.45, 46 The study conducted in Iran showed that the nurse-led education program, together with nurse-led telephone follow-up and a distribution of patient education booklets,t showed significant improvement in adherence score compared to control groups.47 Another study conducted in Turkey, where nurse-led telephone-based education and counselling resulted in significant improvements in self-care skills and quality of life.48 General Objective: To evaluate the effect of nurse-led interventions on self-care adherence and quality of life among patients undergoing hemodialysis Specific Objectives: * To compare the average values of self-care adherence score (adherence to diet and fluid, exercise, and clinical parameters) between the nurse-led intervention group and the usual care group at 2 months and at 6 months. * To compare the quality of life (QOL) scores between the intervention and usual care groups at 6 months baseline. Research Hypothesis 1. There is no significant difference in the mean values of self-care adherence among patients undergoing hemodialysis who receive a nurse-led intervention compared to those who receive usual care at 2 and 6 months. 2. There is no significant difference in the average Kidney Disease Quality of Life (KDQOL) score between patients undergoing hemodialysis who receive a nurse-led intervention and those who receive usual care over 6 months. Study Variables Independent variables: Nurse-led intervention Nurse-led intervention: Comprises an education and counselling session, a reminder call, and distribution of "Self-care booklet for hemodialysis patients." 1. Education and counselling session by nurses (laptop-based): * 1st session (1 to 2 weeks of about 20 minutes): By this session, the nurse makes patients aware of existing interdialytic weight gain status, blood pressures, body mass index, and physical activity. Covers a brief introduction to kidney functions, chronic kidney disease, risk factors, treatment options, dry weight, its importance, and motivational examples. The participants were counselled on the need for behavior change, and assessed whether their behavior is problematic. * 2nd Second session (3 to 4th weeks, about 30 minutes): Increase awareness about healthy behavior, introduction to diet, salt, and fluid, and dietary recommendation session for electrolytes like sodium, sources of potassium and phosphorus, and protein-rich foods, monitoring these parameters in blood, strategies to reduce salt and fluid intake * 3rd Session (5th to 6th weeks, duration 25 min): 3rd session, increase awareness and importance of physical exercise with focus on aerobic, stretching exercises, and deep breathing exercises * 4th session (7 to 8 weeks, duration 25 to 30 min): Introduction to mental health, importance of mental health, common mental health problems in hemodialysis patients, strategies to improve mental health ( ventilation of feelings, quit smoking), 2. Reminder call: Patients will be called once a week on a non-dialysis day. Patient will receive six calls altogether after the third session, once a week on a non-dialysis day. The call will last 3-5 minutes over 6 weeks. The main focus will be on the targeted interdialytic weight control (\<1.5kg) relating to patients' baseline values and between values. Furthermore, patients are encouraged to limit intake of foods rich in sodium, potassium, and phosphorus. Patients are encouraged to engage in physical activity (exercise) and to vent their feelings to a close person. 3. Self-care booklet for hemodialysis patients: Patient will be provided with the small booklet at the end of the last educational session. This booklet has been constructed and reviewed by two nephrologists, two nurse specialists, a physiotherapist, a psychologist, and a nutritionist. Primary variables: Self-care adherence Clinical parameters: interdialytic weight gain Subjective adherence score: Will be assessed by the self-constructed tool on diet, fluid, and salt restriction, as well as monitoring of weight and blood pressure. Physical activity score using the International Physical Activity Questionnaire. Secondary variables: Quality of life, Blood pressure, and Body mass index. Quality of life will be subjectively assessed by the Kidney Disease Quality of Life score (KDQOL-SF 36) Site and its Justification: This study will be conducted at Nepal Medical College and Teaching Hospital. This center is a tertiary care center with around 450 beds. The center has started hemodialysis services around two decades ago (2005, Feb 16). It is the renowned center for hemodialysis services, with approximately 29-31 patients undergoing hemodialysis per shift, and about 213 patients currently receiving this service. Research Design: Quantitative design. This study will be conducted to assess the effects of nurse-led intervention on self-care adherence and quality of life among patients undergoing hemodialysis. Study design: Quasi-experimental design.n Study site: Nepal Medical College Teaching Hospital.Study population: Patients presenting to the dialysis unit at NMCTH will be included. Inclusion criteria: 1) All the patients undergoing hemodialysis who have interdialytic weight gain ≥1.5kg will be approached.d 2) Willing to participate in the study.y 3) Undergoing dialysis at least 2 times a week Sample size Sample size is calculated using Stata software, assuming 5% alpha (a), 80% power (b), a 1:1 allocation ratio for the control and experimental groups, and an effect size of 1.1 for interdialytic weight, with standard deviations of 1.75 for the control group and 1.98 for the experimental group. Mean interdialytic weight of 2.31kg for the control group and 1.21 (I ), study conducted by Pradhan et al in India.47 The sample size calculation is done through the software clincalc .5150 Sample size calculation: n = sample size required in each group µ1=mean change in IDWG from baseline to week 6 in usual care group (2.31kg) µ2=mean change in IDWG from baseline to week 6 in intervention group (1.21 kg) µ1 -µ2= effect size or clinically significant difference =1.1kg σ = standard deviation of experimental group Zα/2: This depends on the level of significanc;, for 5,% this is 1.96 Zβ: This depends on power; for 80%, this is 0.84 Total (n) = 51 hemodialysis patients in each group Calculation of dropout of 10%= 5 patients in each group In total,l 112 patients undergoing hemodialysis will be the final sample size,e and this is the minimum sample size required for the study. Total patients undergoing hemodialysis = 213 Dialysis 2 times a week =213-44 (3 times in a week) =169 IDWG \<1.5 kg (14%) 24 = Meeting eligiblity criteria=169-24=145 Sampling technique: Convenience sampling will be used to select participants for the intervention. Each week, the dialysis patient will be repeated (Sunday/Wednesday, Monday/ Thursday, Tuesday/ Friday). So, each week and day, almost the same patients will be repeated. Patients are grouped by the day they come in due to ethical and moral considerations. Giving more focused care to one patient and giving usual care to others does not look practical. So, selection is done based on the day. (Sunday: Intervention/control), Monday (Intervention/control) Shift-wise for Tuesday shift (Tuesday morning: Intervention/control), Tuesday afternoon (Intervention/control). Number of participants and Justification: The hemodialysis unit of Nepal Medical College serves about 213 patients. This includes patients undergoing dialysis 2 and three times a week. The total number of patients undergoing dialysis twice a week is 169. Considering patients with interdialytic weight gain of at least 1.5 kg, the minimum sample size is 112. Sampling Technique A convenient sampling technique will be used for the quantitative study. Criteria for sample selection Inclusion criteria: 1) All patients undergoing hemodialysis who have interdialytic weight gain ≥1.5kg will be approached. 2) Willing to participate in the study. 3) Undergoing dialysis at least 2 times a week 4) On hemodialysis for at least 3 months 5) Age 18- 69 years Exclusion Criteria: Difficulty in seeing and or hearing problems, Cognitive problems Data Collection Technique Quantitative study: Clinical parameters such as interdialytic weight gain, blood pressure, and height and weight for the calculation of Body mass index will be collected from hospital records. Other outcome measures, like self-care adherence( diet and fluid - self-constructed an international physical activity questionnaire) and quality of life, will be assessed through direct face-to-face interviews. : Data collection tools Tools of data collection: Clinical parameters from patients' charts, like lab values, serum potassium, serum phosphorus, dry weight from patient charts, lab reports, whereas height, weight, and BP were recorded from the patients' medical records. Tools of data collection: Clinical parameters from patients' chart, like lab values, serum potassium, serum phosphorus, dry weight from patient charts, lab reports whereas height, weight, and BP from the patient chart. Interdialytic weight gain (kg): In this study, interdialytic weight gain is defined as the difference between the post-dialysis weight of the prior session and the pre-dialysis weight of the current session. The average weight over the last 2 weeks (4 readings) will be considered the interdialytic weight. Interdialytic weight gain \>1.5 kg is considered nonadherence. Weight: Weight will be measured by the flat hospital digital weighing scale, which has been regularly used in the respective hospital, and is measured in kilograms. Blood Pressure: It will be recorded from patients' medical records, measured using an aneroid blood pressure monitoring device. The average blood pressure over the last four weeks before hemodialysis will be used. Blood pressure will be measured after sitting for at least 5 minutes . Both systolic and diastolic blood pressure will be considered. Body Mass Index (BMI): Body mass index will be measured by the formula weight in kg divided by height in m2 (weight in kg/height in m2). The weight is considered the average of the previous four post-dialytic weights from the baseline. A BMI of 18.5 to 24.9 is considered normal. Self-care adherence: This will be measured subjectively by two separate tools. Adherence to diet and fluid intake will be measured using a self-constructed tool developed by the researcher. Engagement in physical activity will be measured by the standard tool. The participants will be asked, via interview, how frequently they followed dietary and fluid recommendations in the past 2 weeks using a rating scale. There are altogether 26 questions, among which 21 are positive responses with always =5, often = 4, sometimes = 3, rarely=2, and never=1, whereas items (2, 4, 6, 10, 12, 19) are negative scoring items. A higher score indicates higher adherence. The highest possible score is 130, and the lowest possible score is 26. The instrument can be used by taking the mean or median of the obtained score as the cut-off for adherence or non-adherence. The questionnaire has been constructed by reviewing various guidelines and studies (1, 9, 52-53 Among 26 questions, 8 are related to salt, 9 to diet, 5 to fluids, and 4 to monitoring as per advice. The validity of the tool was maintained with a CVI score of 1, and the Cronbach's alpha after pretesting, involving 30 participants at Dhulikhel Hospital, was 0.70. International Physical Activity Questionnaire (IPAQ): The short form comprises 7 questions across 4 activity domains (vigorous, moderate, walking, and sitting). This tool has been modified; instead of the original tool's continuous 10-minute activity, the cumulative activity in minutes over a day is considered. Each activity domain includes: Frequency (days/week) and Duration (minutes/day) of certain activities. Physical activity is scored in MET minutes/week (MET = Metabolic Equivalent of Task). The total Physical Activity Score = sum of MET min/week from all activities. E.g.. MET minutes for moderate activity are 4.4. Suppose someone spends 3 days, averaging 30 min of bicycling or carrying light loads. Then it should be 4 X 3 X 30= 360 MET min/week. Similarly, METS for vigorous activity is 8, moderate intensity 4, and walking 3.3. The tool can be used in numerical or categorical scales. A higher score means a high activity level. A score \<600 MET min/week is considered a low activity level; 600-2999 is moderate;\>3000 is high. The test-retest reliability of IPAQ is 0.74, based on data from 12 countries (51, 54 The participants will be asked how much time they spent in a particular domain within the last seven days. The content validity index obtained after validating with five experts was 1, and the test-retest reliability obtained after pretesting it on 30 patients undergoing hemodialysis at Dhulikhel Hospital was .89. Quality of life: Quality of life in this study refers to individuals' perceived functioning in physical and mental domains resulting from chronic disease. In this study, it will be measured by the Kidney Disease Quality of Life Questionnaire (KDQOL). This question is a Likert-type scale with 36 items, ranging from 2- to 6-point. It has four domains: the SF-12 physical component and mental component summary scales on general health, burden and kidney disease, symptoms and problems, and the effect of kidney disease on daily life. A higher score indicates a better quality of life. This tool is highly reliable, with a Cronbach's alpha of 0.7. 25 Plan for data management and analysis Data Analysis: Will be done using Stata version 14. Collected data will be checked upon completion of the study and entered into an Excel 2010 sheet. Then this will be extracted in Stat 14 software. Descriptive statistics such as frequency, percentage, and mean/median, as well as standard deviation/interquartile range, will be used based on the nature of the data. Similarly, inferential statistics such as t-tests and linear regression analysis will be used to determine the difference in mean scores between two groups. The type of statistical analysis may change depending on the nature of the data. Expected outcome of the research results Improvement in the subjective adherence score and objective parameters (decrease in interdialytic weight gain and blood pressure), and improvement in the quality of life score.

Conditions

• Nurse Led Interventions
• Patients on Hemodialysis
• Self Care
• Quality of Life
• Interdialytic Weight Gain

Interventions

Type	Name	Description
BEHAVIORAL	laptop based education and counselling	1\. Education and counselling session by nurses (laptop-based): 4 session each with 20-30 minutes * 1st session (1 to 2 weeks):The nurse makes patients aware of existing interdialytic weight gain status, blood pressures, body mass index, and physical activity. Covers a brief introduction of kidney, its functions, chronic kidney disease, treatment options, dry weight, and its importance, motivational examples and the need for behavior change. * 2nd session (3 to 4th weeks): Increase awareness about healthy behavior, introduction to diet, salt, and fluid, and dietary recommendation session for sodium, show foods high and low in potassium, phosphorus, and protein, monitoring serum values, and strategies to reduce salt and fluid intake * 3rd Session (5- 6th week): Increase awareness and importance of physical activity and recommended physical activity for participants * 4th session (7- 8th week): Introduction to mental health and strategies to improve mental health
BEHAVIORAL	Reminder call	Participants will be called 4-6 times , once a week on non dialysis day for 3-5 minutes after 2nd session up to 2 months from baseline .
BEHAVIORAL	distribution of self care booklet having all the content covered in discussion	Self care booklet for hemodialysis patients. Books conatins introduction to kidney, chronic kidney disease , its function . This book covers almost all the contents covered in discussion session. It contains the picture of locally avialable spoon with 5 gm salt , locally avilable glass having 100 ml line, list of tables on vegetables and fruits with the potassium and phosphorus in milligrams .

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-11-30
• Completion: 2026-11-30
• First posted: 2026-04-02
• Last updated: 2026-04-02

Locations

1 site across 1 country: Nepal