NCT07506980: Selfcare

Nurse Led Intervention on Self Care Adherence and Quality of Life

Not yet recruiting NA Last updated 2 April 2026

What this trial tests

NA trial testing laptop based education and counselling in Nurse Led Interventions in 112 participants. Not yet recruiting.

Timeline

1 April 2026

Primary endpoint
30 November 2026

30 November 2026

Quick facts

Lead sponsor	Kathmandu University School of Medical Sciences
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	112
Start date	1 April 2026
Primary completion	30 November 2026
Estimated completion	30 November 2026
Sites	1 location across Nepal

Drugs / interventions tested

• laptop based education and counselling
• Reminder call
• distribution of self care booklet having all the content covered in discussion

Conditions studied

• Nurse Led Interventions — all drugs for Nurse Led Interventions →
• Patients on Hemodialysis — all drugs for Patients on Hemodialysis →
• Self Care — all drugs for Self Care →
• Quality of Life — all drugs for Quality of Life →

Sponsor

Kathmandu University School of Medical Sciences

Who can join

Adults 18 to 69, any sex, with Nurse Led Interventions or Patients on Hemodialysis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.