Nurse Led Intervention on Self Care Adherence and Quality of Life

NCT07506980 | Not Yet Recruiting

• 1 other identifier: 038856
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 2 months and 6 months from baseline between the usual care and intervention groups

  The time frame for the assessment of the primary outcome measure is at 2 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.

  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 2 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 2 and 6mths will be assessed.

  This outcome will be measured at 2 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 .

Secondary Outcomes (4)

• Quality of life score

  The change in score at baseline and at 6 months will be compared.

• Body mass index

  baseline and at 2 and 6 months

• pre dialysis systolic blood pressure

  2 months and 4 months baseline . The difference in pre hemodialysis systolic blood pressure at baseline and at 2 and 6 months will be used .

• pre hemodialysis diastolic blood pressure

  at 2 months and 6 months from baseline. The difference in diastolic blood pressure at baseline and at 2 months and 6months will be measured.

Study Arms (2)

Group A, Nurse led intervention ( educational session, telephone reminder, distribution of booklet

EXPERIMENTAL

This group will receive 4 educational and counsellings sessions, for one month for hemodialysis patients. Similarly, reminder calls will be sent (6 in number) and small booklet on self care will be distributed to group A. This group will be assessed at baseline and at 2 months(T1) and four months (T2) from baseline assessment (T0)

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

Group B, Usual group, control group

NO INTERVENTION

The control group will receive usual care, regular round by doctor, advice on fluid control if interdialytic weight gain more than 3 - 4 kg, check for lab reports

Interventions

laptop based education and counselling BEHAVIORAL

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

Also known as: Laptop based education and counselling sessions, Telephopne reminder, Distribution of booklet

Group A, Nurse led intervention ( educational session, telephone reminder, distribution of booklet

Reminder call BEHAVIORAL

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 .

Group A, Nurse led intervention ( educational session, telephone reminder, distribution of booklet

distribution of self care booklet having all the content covered in discussion BEHAVIORAL

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 .

Group A, Nurse led intervention ( educational session, telephone reminder, distribution of booklet

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Kathmandu University School of Medical Sciences: lead

Study Sites (1)

Nepal Medical College and Teaching Hospital

Kathmandu, Bagmati, 4660, Nepal

Location

Related Publications (15)

• 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 BACKGROUND

• 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 BACKGROUND

• 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

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• KDOQI-Clinical-Practice-Guideline-Hemodialysis-Update_Public-Review-Draft-FINAL_20150204.

  BACKGROUND

• Sharma I, Bhattarai M, Sigdel MR. Global Dialysis Perspective: Nepal. Kidney360. 2022 Apr 27;3(7):1269-1274. doi: 10.34067/KID.0001672022. eCollection 2022 Jul 28. No abstract available.

  PMID: 35919532 BACKGROUND

• Bing ZJ, Yap SC, Yie LW. Development of Dialysis and Leakage Detection on Different Technology. ASMScJ 2023; 18: 1-11.

  BACKGROUND

• Hinkle JL, Kerry CH. Textbook of Medical-Surgical Nursing (15th ed.). Philadelphia, USA: Lippincott Williams and Wilkins; 2021.

  BACKGROUND

• Poudyal A, Karki KB, Shrestha N, Aryal KK, Mahato NK, Bista B, Ghimire L, Kc D, Gyanwali P, Jha AK, Garcia-Larsen V, Kuch U, Groneberg DA, Sharma SK, Dhimal M. Prevalence and risk factors associated with chronic kidney disease in Nepal: evidence from a nationally representative population-based cross-sectional study. BMJ Open. 2022 Mar 21;12(3):e057509. doi: 10.1136/bmjopen-2021-057509.

  PMID: 35314475 BACKGROUND

• Kovesdy CP. Epidemiology of chronic kidney disease: an update 2022. Kidney Int Suppl (2011). 2022 Apr;12(1):7-11. doi: 10.1016/j.kisu.2021.11.003. Epub 2022 Mar 18.

  PMID: 35529086 BACKGROUND

• Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney Int. 2024 Apr;105(4S):S117-S314. doi: 10.1016/j.kint.2023.10.018. No abstract available.

  PMID: 38490803 BACKGROUND

Related Links

• Quick kidney disease facts and stats
• Hemodialysis
• International Physical Activity Questionnaire
• Kidney Disease Quality of Life

MeSH Terms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Abja Sapkota, Masters in Nursing

CONTACT

(+977)9841370401; abjasapkota@nmcth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Scholars

Model Details: Quasi experimental design with non equivalent control group design will be used .Here, the study participants are grouped based on the day and shift of dialysis. Patients undertaking hemodialysis 2 times a week will be included. So patients on sunday and wednesday will be the intervention group and patients on monday and thursday will be on control group. Tuesady has remained . So the patients coming on tuesday morning will be on control group and tuesday late evening will be on intervention group .Tuesday day shift acts as a barrier in contact between two groups. Here day and shift wise randomisation done in order to minimise the bias . All this has been done to minimise the contamination or sharing of contents between the groups .

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 2, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)