Chronic Kidney DiseaseNCT07733661
Structured Nursing Education for Hemodialysis Patients
A study testing Structured Nursing Education Program in people with Chronic Kidney Disease and Hemodialysis, run by Sinop University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial was designed to evaluate the effects of a structured nurse-led education program on attitudes toward diet therapy, self-care activities, and chronic disease self-management among patients undergoing maintenance hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Hemodialysis
- What is being tested?
- Structured Nursing Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Jun 2025to 10 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adults aged 18 years or older.
- Receiving maintenance hemodialysis treatment.
- Able to communicate in Turkish.
- Able to read and write.
- Willing to participate and provided written informed consent.
Who cannot join
- Cognitive impairment or severe psychiatric disorder preventing participation.
- Serious medical condition preventing completion of the education program.
- Participation in another structured educational intervention during the study period.
- Withdrawal of consent before completion of the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Private Sinop Dialysis Center
Sinop, Sinop, 57000
About this study
Official title: The Effect of a Structured Nursing Education Program on Attitudes Toward Diet Therapy, Self-Care, and Chronic Disease Self-Management in Patients Undergoing Hemodialysis: A Randomized Controlled Trial
This randomized controlled trial was designed to evaluate the effects of a structured nurse-led education program on attitudes toward diet therapy, self-care activities, and chronic disease self-management among patients undergoing maintenance hemodialysis. Sixty eligible patients receiving maintenance hemodialysis were randomly assigned to either the intervention group (n = 30) or the control group (n = 30). Participants in the intervention group received a structured nurse-led education program consisting of eight face-to-face educational sessions delivered over four weeks (two sessions per week), while the control group received routine care without additional educational intervention. The primary outcomes were attitudes toward diet therapy, self-care activities, and chronic disease self-management, which were assessed before and after the intervention using the Hemodialysis Patients' Attitudes Toward Diet Therapy Scale (HPADTS), the Self-Care Activities Screening Scale-14 (SCAS-14), and the Chronic Illness Self-Management Scale (CISMS).
Read the detailed description
This randomized controlled trial was designed to evaluate the effects of a structured nurse-led education program on attitudes toward diet therapy, self-care activities, and chronic disease self-management among patients undergoing maintenance hemodialysis.
The study was carried out in the hemodialysis unit of a private dialysis center in the Black Sea region of Türkiye. Sixty eligible patients receiving maintenance hemodialysis were randomly assigned to either an intervention group (n = 30) or a control group (n = 30). Cluster randomization at the dialysis-session level was used to minimize contamination between participants. Outcome data were analyzed by a blinded statistician.
Participants in the intervention group received a structured nurse-led education program consisting of eight face-to-face sessions delivered over four weeks (two sessions per week). The educational program included chronic kidney disease and hemodialysis, treatment adherence, dietary therapy, nutritional management, fluid and electrolyte restrictions, self-care skills, chronic disease self-management, anemia management, and reinforcement of learning. The control group received routine care without additional educational intervention.
The primary outcomes were attitudes toward diet therapy, self-care activities, and chronic disease self-management. These outcomes were assessed at baseline and immediately after completion of the intervention using validated instruments, including the Hemodialysis Patients' Attitudes Toward Diet Therapy Scale (HPADTS), the Self-Care Activities Screening Scale-14 (SCAS-14), and the Chronic Disease Self-Management Scale (CDSMS).
The educational program was developed based on Orem's Self-Care Deficit Nursing Theory and was designed to address self-care, dietary therapy, and chronic disease self-management among patients undergoing maintenance hemodialysis.
- Conditions
- Chronic Kidney Disease, Hemodialysis
- Being tested
- Structured Nursing Education Program
- Keywords
- Hemodialysis, structured nursing education, nursing, attitudes toward diet therapy, self-care activities, chronic disease self-management
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Nursing Education ProgramBehavioural
Participants received a structured nurse-led education program consisting of eight face-to-face sessions delivered over four weeks (two sessions per week). The program included education on chronic kidney disease, hemodialysis, dietary therapy, nutrition, fluid management, self-care, chronic disease self-management, anemia management, and reinforcement of learning
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants in the intervention group received a structured nurse-led education program consisting of eight face-to-face sessions delivered over four weeks (two sessions per week), in addition to routine hemodialysis care. The program covered chronic kidney disease, hemodialysis, dietary therapy, nutrition, fluid management, self-care, chronic disease self-management, anemia management, and reinforcement of learning Receives: Behavioral: Structured Nursing Education Program |
| Control Group | No intervention | Participants in the control group received routine hemodialysis care provided by the dialysis center and did not receive the structured nurse-led education program during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Information Form
The Participant Information Form was developed by the researchers to collect participants' sociodemographic and clinical characteristics. The questionnaire included items on age, sex, educational level, marital status, smoking status, alcohol consumption, and duration of hemodialysis treatment.
Measured: Baseline and immediately after completion of the 4-week intervention
Hemodialysis Patients' Attitudes Toward Diet Therapy Scale (HPADTS)
The Hemodialysis Patients' Attitudes Toward Diet Therapy Scale (HPADTS), originally developed by Onbe and Kanda (2018), was used to evaluate patients' attitudes toward dietary therapy. Hemodialysis Patients' Attitudes Toward Diet Therapy Scale (HPADTS). The scale consists of 16 items scored on a 4-point Likert scale, with total scores ranging from 16 to 64. Higher scores indicate more positive attitudes toward diet therapy. The scale consists of 16 items distributed across three subscales: Behavioral Tendency Influenced by Cognition (BTIC) (7 items), Behavioral Tendency Influenced by Food Culture (BTIFC) (6 items), and Negative Effects Leading to Dietary Modification (NELDM) (3 items). Each item is rated on a four-point Likert scale. The final three items are reverse scored. Higher total scores indicate more positive attitudes toward dietary therapy.
Measured: Baseline and immediately after completion of the 4-week intervention
Self-Care Activities Screening Scale (SASS-14)
Self-care activities were assessed using the Self-Care Activities Screening Scale (SASS-14), which comprises 14 items grouped into four subscales: Health Consciousness (HC), Nutrition and Physical Activity (NPA), Sleep (SLP), and Interpersonal and Intrapersonal Coping Skills (IICS). Items are rated on a six-point Likert scale, yielding total scores ranging from 14 to 84, with higher scores indicating greater engagement in self-care activities. In the original validation study, the overall Cronbach's alpha coefficient was 0.80 (Bermejo-Martins et al., 2021). The Turkish adaptation demonstrated good internal consistency, with a Cronbach's alpha coefficient of 0.85 (Tarus et al., 2024).
Measured: Baseline and immediately after completion of the 4-week intervention
Chronic Disease Self-Management Scale (CDSMS)
Chronic disease self-management was assessed using the Chronic Disease Self-Management Scale (CDSMS). The instrument consists of 21 items across four subscales: Self-Stigma (7 items), Coping with Stigma (5 items), Health Care Efficacy (4 items), and Treatment Adherence (5 items). All items are scored using a five-point Likert scale. The reported Cronbach's alpha coefficients for the subscales range from 0.715 to 0.879. The Turkish validity and reliability study of the instrument was conducted by Öztürk et al. (2021). Chronic Disease Self-Management Scale (CDSMS). The scale consists of 21 items scored on a 5-point Likert scale, with total scores ranging from 21 to 105. Higher scores indicate better chronic disease self-management.
Measured: Baseline and immediately after completion of the 4-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start9 Jun 2025
- Primary completion10 Oct 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- 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 were randomly assigned in a 1:1 ratio to either the intervention group or the control group. Cluster randomization at the dialysis-session level was used to minimize contamination between groups. The intervention group received a structured nurse-led education program, whereas the control group received routine care.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinop University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin OZYER, Sinop University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733661
- Sponsor's protocol ID
- 2 0 2 5 / 2 5 7
- Status last verified
- Jul 2026
- First submitted
- 19 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Structured Nursing Education Program on Attitudes Toward Diet Therapy, Self-Care, and Chronic Disease Self-Management in Patients Undergoing Hemodialysis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07733661
- Acronym / sponsor ID
- 2 0 2 5 / 2 5 7
- Conditions
- Chronic Kidney Disease, Hemodialysis
- Keywords
- Hemodialysis, structured nursing education, nursing, attitudes toward diet therapy, self-care activities, chronic disease self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sinop UniversityUniversity, hospital or other
- Study start
- 9 Jun 2025 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 29 Jul 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.
This randomized controlled trial was designed to evaluate the effects of a structured nurse-led education program on attitudes toward diet therapy, self-care activities, and chronic disease self-management among patients undergoing maintenance hemodialysis. Sixty eligible patients receiving maintenance hemodialysis were randomly assigned to either the intervention group (n = 30) or the control group (n = 30). Participants in the intervention group received a structured nurse-led education program consisting of eight face-to-face educational sessions delivered over four weeks (two sessions per week), while the control group received routine care without additional educational intervention. The primary outcomes were attitudes toward diet therapy, self-care activities, and chronic disease self-management, which were assessed before and after the intervention using the Hemodialysis Patients' Attitudes Toward Diet Therapy Scale (HPADTS), the Self-Care Activities Screening Scale-14 (SCAS-14), and the Chronic Illness Self-Management Scale (CISMS).
Detailed description
This randomized controlled trial was designed to evaluate the effects of a structured nurse-led education program on attitudes toward diet therapy, self-care activities, and chronic disease self-management among patients undergoing maintenance hemodialysis.
The study was carried out in the hemodialysis unit of a private dialysis center in the Black Sea region of Türkiye. Sixty eligible patients receiving maintenance hemodialysis were randomly assigned to either an intervention group (n = 30) or a control group (n = 30). Cluster randomization at the dialysis-session level was used to minimize contamination between participants. Outcome data were analyzed by a blinded statistician.
Participants in the intervention group received a structured nurse-led education program consisting of eight face-to-face sessions delivered over four weeks (two sessions per week). The educational program included chronic kidney disease and hemodialysis, treatment adherence, dietary therapy, nutritional management, fluid and electrolyte restrictions, self-care skills, chronic disease self-management, anemia management, and reinforcement of learning. The control group received routine care without additional educational intervention.
The primary outcomes were attitudes toward diet therapy, self-care activities, and chronic disease self-management. These outcomes were assessed at baseline and immediately after completion of the intervention using validated instruments, including the Hemodialysis Patients' Attitudes Toward Diet Therapy Scale (HPADTS), the Self-Care Activities Screening Scale-14 (SCAS-14), and the Chronic Disease Self-Management Scale (CDSMS).
The educational program was developed based on Orem's Self-Care Deficit Nursing Theory and was designed to address self-care, dietary therapy, and chronic disease self-management among patients undergoing maintenance hemodialysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to either the intervention group or the control group. Cluster randomization at the dialysis-session level was used to minimize contamination between groups. The intervention group received a structured nurse-led education program, whereas the control group received routine care.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Structured Nursing Education ProgramParticipants in the intervention group received a structured nurse-led education program consisting of eight face-to-face sessions delivered over four weeks (two sessions per week), in addition to routine hemodialysis care. The program covered chronic kidney disease, hemodialysis, dietary therapy, nutrition, fluid management, self-care, chronic disease self-management, anemia management, and reinforcement of learning |
| Control Group | No intervention | –Participants in the control group received routine hemodialysis care provided by the dialysis center and did not receive the structured nurse-led education program 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 (5 listed)
- Adults aged 18 years or older.
- Receiving maintenance hemodialysis treatment.
- Able to communicate in Turkish.
- Able to read and write.
- Willing to participate and provided written informed consent.
Key exclusion criteria (4 listed)
- Cognitive impairment or severe psychiatric disorder preventing participation.
- Serious medical condition preventing completion of the education program.
- Participation in another structured educational intervention during the study period.
- Withdrawal of consent before completion of the study.
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 |
|---|---|---|
| Structured Nursing Education ProgramParticipants received a structured nurse-led education program consisting of eight face-to-face sessions delivered over four weeks (two sessions per week). The program included education on chronic kidney disease, hemodialysis, dietary therapy, nutrition, fluid management, self-care, chronic disease self-management, anemia management, and reinforcement of learning | Behavioural | Intervention Group |
Primary outcome
Participant Information Form
Time frame: Baseline and immediately after completion of the 4-week intervention
The Participant Information Form was developed by the researchers to collect participants' sociodemographic and clinical characteristics. The questionnaire included items on age, sex, educational level, marital status, smoking status, alcohol consumption, and duration of hemodialysis treatment.
Hemodialysis Patients' Attitudes Toward Diet Therapy Scale (HPADTS)
Time frame: Baseline and immediately after completion of the 4-week intervention
The Hemodialysis Patients' Attitudes Toward Diet Therapy Scale (HPADTS), originally developed by Onbe and Kanda (2018), was used to evaluate patients' attitudes toward dietary therapy. Hemodialysis Patients' Attitudes Toward Diet Therapy Scale (HPADTS). The scale consists of 16 items scored on a 4-point Likert scale, with total scores ranging from 16 to 64. Higher scores indicate more positive attitudes toward diet therapy. The scale consists of 16 items distributed across three subscales: Behavioral Tendency Influenced by Cognition (BTIC) (7 items), Behavioral Tendency Influenced by Food Culture (BTIFC) (6 items), and Negative Effects Leading to Dietary Modification (NELDM) (3 items). Each item is rated on a four-point Likert scale. The final three items are reverse scored. Higher total scores indicate more positive attitudes toward dietary therapy.
Self-Care Activities Screening Scale (SASS-14)
Time frame: Baseline and immediately after completion of the 4-week intervention
Self-care activities were assessed using the Self-Care Activities Screening Scale (SASS-14), which comprises 14 items grouped into four subscales: Health Consciousness (HC), Nutrition and Physical Activity (NPA), Sleep (SLP), and Interpersonal and Intrapersonal Coping Skills (IICS). Items are rated on a six-point Likert scale, yielding total scores ranging from 14 to 84, with higher scores indicating greater engagement in self-care activities. In the original validation study, the overall Cronbach's alpha coefficient was 0.80 (Bermejo-Martins et al., 2021). The Turkish adaptation demonstrated good internal consistency, with a Cronbach's alpha coefficient of 0.85 (Tarus et al., 2024).
Chronic Disease Self-Management Scale (CDSMS)
Time frame: Baseline and immediately after completion of the 4-week intervention
Chronic disease self-management was assessed using the Chronic Disease Self-Management Scale (CDSMS). The instrument consists of 21 items across four subscales: Self-Stigma (7 items), Coping with Stigma (5 items), Health Care Efficacy (4 items), and Treatment Adherence (5 items). All items are scored using a five-point Likert scale. The reported Cronbach's alpha coefficients for the subscales range from 0.715 to 0.879. The Turkish validity and reliability study of the instrument was conducted by Öztürk et al. (2021). Chronic Disease Self-Management Scale (CDSMS). The scale consists of 21 items scored on a 5-point Likert scale, with total scores ranging from 21 to 105. Higher scores indicate better chronic disease self-management.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Nursing Education Program in people with Chronic Kidney Disease and Hemodialysis, run by Sinop 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 29 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Information Form (time frame: Baseline and immediately after completion of the 4-week intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2026.