Nurse-Led Dialysis Self-Management Program for Hemodialysis Distress

NCT07747012 | Not Yet Recruiting

• 1 other identifier: KSBU-HD-RCT-2026-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Hemodialysis patients may experience dialysis-related distress due to long-term treatment requirements, dietary and fluid restrictions, medication use, vascular access problems, dialysis-related symptoms, and psychosocial challenges. Nurse-led self-management programs may help patients improve dialysis self-management, reduce distress, and support treatment adherence. This study aims to evaluate the effect of a nurse-led needs-based dialysis self-management program on dialysis-related distress in patients receiving hemodialysis. The study will be conducted as a single-center, two-arm, parallel-group, randomized controlled trial. A total of 100 adult hemodialysis patients will be randomly assigned to either the intervention group or the control group in a 1:1 ratio. Participants in the intervention group will receive a 6-week nurse-led needs-based dialysis self-management program in addition to routine hemodialysis care. Participants in the control group will continue routine hemodialysis care. Data will be collected at baseline, 6 weeks, and 18 weeks. The primary outcome is dialysis-related distress. Secondary outcomes include illness and treatment uncertainty, treatment adherence, and clinical adherence indicators.

Conditions

Hemodialysis; Dialysis-Related Distress

Keywords

Hemodialysis; Dialysis-related distress; Self-management; Nursing intervention; Patient education; Treatment adherence; Illness uncertainty

Outcome Measures

Primary Outcomes (1)

• Dialysis-Related Distress Assessed by the Hemodialysis Distress Thermometer

  Dialysis-related distress will be assessed using the Hemodialysis Distress Thermometer. The instrument includes a distress barometer scored from 0 to 10, where 0 indicates no distress and 10 indicates extreme distress. Higher scores indicate higher perceived dialysis-related distress. The instrument also includes a 40-item problem checklist scored from 0 to 40, where higher scores indicate a greater number of distress-related problems.

  Baseline, 6 weeks, and 18 weeks

Secondary Outcomes (2)

• Illness and Treatment Uncertainty Assessed by the Uncertainty in Chronic Dialysis Treatment Scale

  Baseline, 6 weeks, and 18 weeks

• Treatment Adherence Assessed by the End-Stage Renal Disease Adherence Questionnaire

  Baseline, 6 weeks, and 18 weeks

Study Arms (2)

Nurse-Led Needs-Based Dialysis Self-Management Program

EXPERIMENTAL

Participants in this arm will receive a 6-week nurse-led needs-based dialysis self-management program in addition to routine hemodialysis care. The program includes weekly face-to-face individual sessions lasting approximately 40 to 45 minutes. The intervention includes standard core education and needs-based individualized counseling focused on fluid management, diet, medication adherence, symptom and distress management, treatment uncertainty, and sustainable dialysis self-management.

Behavioral: Nurse-Led Needs-Based Dialysis Self-Management Program

Routine Hemodialysis Care

ACTIVE COMPARATOR

Participants in this arm will continue to receive routine hemodialysis care. No additional structured education or counseling program will be provided by the research team during the study period.

Behavioral: Routine Hemodialysis Care

Interventions

Nurse-Led Needs-Based Dialysis Self-Management Program BEHAVIORAL

The intervention is a structured 6-week nurse-led needs-based dialysis self-management program. It will be delivered through weekly face-to-face individual sessions lasting approximately 40 to 45 minutes. The program includes standard core education and needs-based individualized counseling. The content focuses on the hemodialysis process and individual needs assessment, fluid management and interdialytic weight control, diet and potassium/phosphorus management, medication adherence and treatment continuity, symptom and distress management, coping with treatment uncertainty, and development of a sustainable dialysis self-management plan. Intervention fidelity will be monitored using a standardized session checklist.

Nurse-Led Needs-Based Dialysis Self-Management Program

Routine Hemodialysis Care BEHAVIORAL

Participants will continue to receive routine hemodialysis care. No additional structured education or counseling program will be provided by the research team during the study period.

Routine Hemodialysis Care

Eligibility Criteria

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

You may qualify if:

• Aged 18 years or older
• Receiving hemodialysis treatment for at least 3 months
• Receiving hemodialysis treatment at least twice per week
• Able to read and understand Turkish
• Conscious and able to communicate
• Providing written informed consent

You may not qualify if:

• Advanced cognitive impairment
• Active psychiatric crisis
• History of major surgery or acute severe illness within the last 3 months
• Planned kidney transplantation in the near future
• Serious physical or communication problems that may prevent regular participation in the intervention sessions
• Concurrent participation in another structured education or psychosocial intervention program

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Simav Doc. Dr. Ismail Karakuyu State Hospital

Simav, Turkey (Türkiye)

Location

Related Publications (3)

• Liu L, Liu YP, Wang J, An LW, Jiao JM. Use of a knowledge-attitude-behaviour education programme for Chinese adults undergoing maintenance haemodialysis: Randomized controlled trial. J Int Med Res. 2016 Jun;44(3):557-68. doi: 10.1177/0300060515604980. Epub 2016 Mar 7.

  PMID: 26951842 BACKGROUND

• Liu Y, Luo X, Ru X, Wen C, Ding N, Zhang J. Impact of a multimodal health education combined with teach-back method on self-management in hemodialysis patients: A randomized controlled trial. Medicine (Baltimore). 2024 Dec 27;103(52):e39971. doi: 10.1097/MD.0000000000039971.

  PMID: 39969380 BACKGROUND

• Sousa H, Ribeiro O, Figueiredo D. Development process, clinical utility, and preliminary psychometric evidence of a new tool for screening psychological distress in renal care settings: the Hemodialysis Distress Thermometer (HD-DT). Psychol Health. 2025 Oct;40(10):1658-1684. doi: 10.1080/08870446.2024.2347662. Epub 2024 Apr 28.

  PMID: 38679920 BACKGROUND

MeSH Terms

Conditions

Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Central Study Contacts

Serkan Budak, PhD / RN

CONTACT

+905385430616; serkan.budak@ksbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and intervention providers cannot be masked due to the nature of the behavioral nursing intervention. Outcome assessment and data analysis will be conducted with group codes masked.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 1:1 ratio to either the nurse-led needs-based dialysis self-management program group or the routine hemodialysis care group.

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 5, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: August 5, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)