Nurse Led Intervention on Self Care Adherence and Quality of Life
NCT07506980 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112
Last updated 2026-07-31
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 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.
Conditions
- Nurse Led Interventions
- Patients on Hemodialysis
- Self Care
- Quality of Life
- Interdialytic Weight Gain
Interventions
- 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 4 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 .
Sponsors & Collaborators
-
Kathmandu University School of Medical Sciences
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 69 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-30
- Primary Completion
- 2026-09-30
- Completion
- 2026-11-30
Countries
- Nepal
Study Locations
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