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Идёт набор NCT07506980

Nurse Led Intervention on Self Care Adherence and Quality of Life

Без фазы С лечением Nurse Led Interventions Patients on Hemodialysis Self Care Quality of Life

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: laptop based education and counselling, Reminder call, distribution of self care booklet having all the content covered in discussion.
Кому может быть актуально
Состояния в реестре: Nurse Led Interventions, Patients on Hemodialysis, Self Care, Quality of Life. Базовые параметры: 18 лет — 69 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Nepal
Следующий шаг
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Официальное название

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

Обзор

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 4 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.

Подробное описание

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 4 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 4 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 w

Вмешательства

  • Поведенческое 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 ab
  • Поведенческое 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 4 months from baseline .
  • Поведенческое 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 .

Первичные конечные точки

  • Change in Interdialytic weight gain in kilograms [Срок оценки: The time frame for the assessment of the primary outcome measure is at 4 months and 6 months from the baseline.]
  • Self care adherence : The self care adherence will be measured by two instruments through interview methods. For diet and fluid self constructed tools will be used and for physical activity international physical activity questions will be adopted. [Срок оценки: This outcome will be measured at 4 months and at 6 months from the baseline . The outcome will be assessed by the researcher along with trained eneumerator having bachelor degree in nursing .]
Вторичные конечные точки (4)
  • Quality of life score [Срок оценки: The change in score at baseline and at 6 months will be compared.]
  • Body mass index [Срок оценки: baseline and at 4 and 6 months]
  • pre dialysis systolic blood pressure [Срок оценки: 4 months and 6 months baseline . The difference in pre hemodialysis systolic blood pressure at baseline and at 4 and 6 months will be used .]
  • pre hemodialysis diastolic blood pressure [Срок оценки: at 4 months and 6 months from baseline. The difference in diastolic blood pressure at baseline and at 4 months and 6months will be measured.]

Критерии участия

Критерии включения

Age 18-69 years. Have interdialytic weight gain more than or equal to 1.5 kg. In dialysis treatment twice a week for the last 3 months. Provide consent in verbal and written form Having a mobile phone to use on one's own or with family members.

Exclusion Criteria: Self-reported hearing difficulty and visual difficulty.Cognitive problems such as memory loss, language difficulties, and forgetfulness. Having heart problems like dysrhythmia, ventricular heart disease, or reduced ejection fraction requires oxygen at the time of dialysis.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Nepal · 2 центра
  • Nepal Medical College Teaching Hospital — Gokarna
  • Nepal Medical College and Teaching Hospital — Kathmandu

Публикации

  • Howren MB, Kellerman QD, Hillis SL, Cvengros J, Lawton W, Christensen AJ. Effect of a Behavioral Self-Regulation Intervention on Patient Adherence to Fluid-Intake Restrictions in Hemodialysis: a Randomized Controlled Trial. Ann Behav Med. 2016 Apr;50(2):167-76. doi: 10.1007/s12160-015-9741-0. PMID 26631085
  • Bossola M, Pepe G, Antocicco M, Severino A, Di Stasio E. Interdialytic weight gain and educational/cognitive, counseling/behavioral and psychological/affective interventions in patients on chronic hemodialysis: a systematic review and meta-analysis. J Nephrol. 2022 Nov;35(8):1973-1983. doi: 10.1007/s40620-022-01450-6. Epub 2022 Sep 16. PMID 36112313
  • VR V, Kang HK. The effect of nurse-led interventions on non-adherence to dietary and fluid restrictions among adults receiving haemodialysis: a randomised controlled trial. Journal of Kidney Care 2023 ; 8(1):12-25
  • Arad M, Goli R, Parizad N, Vahabzadeh D, Baghaei R. Do the patient education program and nurse-led telephone follow-up improve treatment adherence in hemodialysis patients? A randomized controlled trial. BMC Nephrol. 2021 Apr 7;22(1):119. doi: 10.1186/s12882-021-02319-9. PMID 33827478
  • Tutur I, Bicer EK. The Effect of Nurse-Led Telephone Patient Education and Counseling on Disease Management, Quality of Life, and Self-Care Behaviors in Hemodialysis Patients. Worldviews Evid Based Nurs. 2025 Dec;22(6):e70074. doi: 10.1111/wvn.70074. PMID 41174863
  • Baker LA, March DS, Wilkinson TJ, Billany RE, Bishop NC, Castle EM, Chilcot J, Davies MD, Graham-Brown MPM, Greenwood SA, Junglee NA, Kanavaki AM, Lightfoot CJ, Macdonald JH, Rossetti GMK, Smith AC, Burton JO. Clinical practice guideline exercise and lifestyle in chronic kidney disease. BMC Nephrol. 2022 Feb 22;23(1):75. doi: 10.1186/s12882-021-02618-1. No abstract available. PMID 35193515
  • Tentori F, Elder SJ, Thumma J, Pisoni RL, Bommer J, Fissell RB, Fukuhara S, Jadoul M, Keen ML, Saran R, Ramirez SP, Robinson BM. Physical exercise among participants in the Dialysis Outcomes and Practice Patterns Study (DOPPS): correlates and associated outcomes. Nephrol Dial Transplant. 2010 Sep;25(9):3050-62. doi: 10.1093/ndt/gfq138. Epub 2010 Apr 13. PMID 20392706
  • Sapkota A, Sedhain A, Kc T, Sigdel S, Subedi S. Adherence to Treatment among Patients With End-Stage Renal Disease Undergoing Hemodialysis In Selected Centers In Nepal. J Nepal Health Res Counc. 2022 Jun 2;20(1):72-78. doi: 10.33314/jnhrc.v20i01.3828. PMID 35945856

Идентификаторы

NCT: NCT07506980 · 038856

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗