About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
laptop based education and counselling
Behavioral1\. 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
Reminder call
BehavioralParticipants 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 .
distribution of self care booklet having all the content covered in discussion
BehavioralSelf 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 .
Treatment groups
Trial outcomes
Primary outcomes
Change in Interdialytic weight gain in kilograms
Interdialytic weight gain (IDWG): The IDWG is the difference between the pre-dialysis weight and the post-dialysis weight of the last session. The weight will be taken from the patient's charts, which were recorded in kilograms. In this study, IDWG will be the average of the weights taken in the last two weeks. Altogether, there were four predialysis weights and four post dialysis weight. The average of the four interdialytic weights will be considered. The usual practice for the measurement of the weight is by the use of the dialysis weighing scale that has been in use regularly for dialysis patient. The difference in the interdialytic weight at baseline and at 4 months and 6 months from baseline between the usual care and intervention groups
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.
Measured subjectively by two separate tools. Adherence to diet and fluid: Measure by the self-constructed tool developed by the researcher.The tool contains 26 items related to salt, fluid, diet, and regular monitoring of weight and blood pressure. Participants will be asked how frequently they followed the diet and fluid recommendations provided by the health care providers. A higher score indicates higher adherence. The difference between the score at baseline and at 4 months and 6 months will be assessed. Adherence to physical activity : The Engagement in physical activity will be measured by the standard tool international physical activity questionnaire. Here also highest score indicates higher adherence and lower score indicates lower adherence. The difference between the activity score at baseline and at 4 and 6mths will be assessed.
Secondary outcomes
Quality of life score
Quality of life will be assessed by the translated nepali version of the kidney disease quality of life questionnaire. Here the higher score indicates better quality of life . The change in the score at 6 months and at baseline will be assessed .
Body mass index
Body mass index will be measured by the weight in kg divided by height in m2 (kg/m2). The weight will be measured by the average of the four post dialysis weight. It is the difference in BMI at the baseline and 6 months
pre dialysis systolic blood pressure
The pre hemodialysis blood pressure will be recorded from the patients chart. The average of the four pre hemodialysis systolic blood pressure will be considered as the systolic blood pressure .The usual practice of the blood pressure measurement is by the aneroid blood pressure measurement. This will be done by the registered nurse with the patient sitting on a chair, with the feet touching the floor. The patient will be sitted on a chair for at least five minutes before taking the blood pressure. This is measured in mm of Hg .
pre hemodialysis diastolic blood pressure
Description: The pre hemodialysis blood pressure will be recorded from the patients chart. The average of the four pre hemodialysis diastolic blood pressure will be considered as the diastolic blood pressure .The usual practice of the blood pressure measurement is by the aneroid blood pressure measurement. This will be done by the registered nurse with the patient sitting on a chair, with the feet touching the floor. The patient will be sitted on a chair for at least five minutes before taking the blood pressure. This is measured in mm of Hg.
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