HemodialysisNCT07747012
Nurse-Led Dialysis Self-Management Program for Hemodialysis Distress
A study testing Nurse-Led Needs-Based Dialysis Self-Management Program and Routine Hemodialysis Care in people with Hemodialysis and Dialysis-Related Distress, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis, Dialysis-Related Distress
- What is being tested?
- Nurse-Led Needs-Based Dialysis Self-Management Program and Routine Hemodialysis Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2026to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Simav Doc. Dr. Ismail Karakuyu State Hospital
Simav
About this study
Official title: The Effect of a Nurse-Led Needs-Based Dialysis Self-Management Program on Dialysis-Related Distress in Hemodialysis Patients: A Randomized Controlled Trial
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.
Read the detailed description
The intervention is a structured, non-invasive, education- and counseling-based behavioral nursing intervention. The nurse-led needs-based dialysis self-management program aims to improve self-management skills, reduce dialysis-related distress, decrease illness and treatment uncertainty, and support treatment adherence.
The program will be delivered over 6 weeks through weekly face-to-face individual sessions lasting approximately 40 to 45 minutes. The intervention includes two components: standard core education and needs-based individualized counseling. Standard core education will be delivered to all participants in the intervention group. Individualized counseling will be guided by participants' baseline dialysis-related distress, illness and treatment uncertainty, treatment adherence, and clinical indicators.
The intervention content includes 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 self-management plan. Intervention fidelity will be monitored using a standardized session checklist.
- Conditions
- Hemodialysis, Dialysis-Related Distress
- Being tested
- Nurse-Led Needs-Based Dialysis Self-Management Program, Routine Hemodialysis Care
- Keywords
- Hemodialysis, Dialysis-related distress, Self-management, Nursing intervention, Patient education, Treatment adherence, Illness uncertainty
- Medical subject headings
- Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-Led Needs-Based Dialysis Self-Management ProgramBehavioural
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.
Routine Hemodialysis CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Routine Hemodialysis Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 weeks, and 18 weeks
Secondary outcomes (2)
Illness and Treatment Uncertainty Assessed by the Uncertainty in Chronic Dialysis Treatment Scale
Illness and treatment uncertainty will be assessed using the Uncertainty in Chronic Dialysis Treatment Scale. The scale includes 17 items and five subscales. Total raw scores range from 17 to 85 and can be transformed to a 0 to 100 scale. Higher scores indicate higher illness and treatment uncertainty.
Measured: Baseline, 6 weeks, and 18 weeks
Treatment Adherence Assessed by the End-Stage Renal Disease Adherence Questionnaire
Treatment adherence will be assessed using the End-Stage Renal Disease Adherence Questionnaire. The scale includes 9 items and four subscales: hemodialysis attendance, medication use, fluid restriction, and diet restriction. Total scores range from 0 to 1200. Higher scores indicate higher adherence to treatment.
Measured: Baseline, 6 weeks, and 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start1 Aug 2026
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747012
- Sponsor's protocol ID
- KSBU-HD-RCT-2026-01
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study includes sensitive health-related information from patients receiving hemodialysis. De-identified aggregate results may be reported in scientific publications.
Publications
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.
PubMed 26951842Liu 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.
PubMed 39969380Sousa 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.
PubMed 38679920
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Nurse-Led Needs-Based Dialysis Self-Management Program on Dialysis-Related Distress in Hemodialysis Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07747012
- Acronym / sponsor ID
- KSBU-HD-RCT-2026-01
- Conditions
- Hemodialysis, Dialysis-Related Distress
- Keywords
- Hemodialysis, Dialysis-related distress, Self-management, Nursing intervention, Patient education, Treatment adherence, Illness uncertainty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The intervention is a structured, non-invasive, education- and counseling-based behavioral nursing intervention. The nurse-led needs-based dialysis self-management program aims to improve self-management skills, reduce dialysis-related distress, decrease illness and treatment uncertainty, and support treatment adherence.
The program will be delivered over 6 weeks through weekly face-to-face individual sessions lasting approximately 40 to 45 minutes. The intervention includes two components: standard core education and needs-based individualized counseling. Standard core education will be delivered to all participants in the intervention group. Individualized counseling will be guided by participants' baseline dialysis-related distress, illness and treatment uncertainty, treatment adherence, and clinical indicators.
The intervention content includes 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 self-management plan. Intervention fidelity will be monitored using a standardized session checklist.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Nurse-Led Needs-Based Dialysis Self-Management Program | Experimental | Behavioral: Nurse-Led Needs-Based Dialysis Self-Management ProgramParticipants 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. |
| Routine Hemodialysis Care | Active comparator | Behavioral: Routine Hemodialysis CareParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-Led Needs-Based Dialysis Self-Management ProgramThe 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. | Behavioural | Nurse-Led Needs-Based Dialysis Self-Management Program |
| Routine Hemodialysis CareParticipants 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. | Behavioural | Routine Hemodialysis Care |
Primary outcome
Dialysis-Related Distress Assessed by the Hemodialysis Distress Thermometer
Time frame: Baseline, 6 weeks, and 18 weeks
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.
2 secondary outcomes
Illness and Treatment Uncertainty Assessed by the Uncertainty in Chronic Dialysis Treatment Scale
Time frame: Baseline, 6 weeks, and 18 weeks
Treatment Adherence Assessed by the End-Stage Renal Disease Adherence Questionnaire
Time frame: Baseline, 6 weeks, and 18 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Background: PubMed 26951842Liu 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.
- Background: PubMed 39969380Liu 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.
- Background: PubMed 38679920Sousa 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study includes sensitive health-related information from patients receiving hemodialysis. De-identified aggregate results may be reported in scientific publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-Led Needs-Based Dialysis Self-Management Program and Routine Hemodialysis Care in people with Hemodialysis and Dialysis-Related Distress, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Serkan Budak, PhD / RN (+905385430616, serkan.budak@ksbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dialysis-Related Distress Assessed by the Hemodialysis Distress Thermometer (time frame: Baseline, 6 weeks, and 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07747012, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.