Structured Nursing Education for Hemodialysis Patients

NCT07733661 | Completed

• 1 other identifier: 2 0 2 5 / 2 5 7
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Chronic Kidney Disease; Hemodialysis

Keywords

Hemodialysis; structured nursing education; nursing; attitudes toward diet therapy; self-care activities; chronic disease self-management

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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).

  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.

  Baseline and immediately after completion of the 4-week intervention

Study Arms (2)

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

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.

Interventions

Structured Nursing Education Program BEHAVIORAL

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

Intervention Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sinop University: lead

Study Sites (1)

Private Sinop Dialysis Center

Sinop, Sinop, 57000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This was a single-blind randomized controlled trial. Due to the nature of the educational intervention, participants and the nurse educator could not be blinded. However, the statistician who analyzed the study data was blinded to group allocation, and anonymized data were used during statistical analysis.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 19, 2026
• First Posted: July 29, 2026
• Study Start: June 9, 2025
• Primary Completion: October 10, 2025
• Study Completion: October 10, 2025
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)