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Nurse-Led Dialysis Self-Management Program for Hemodialysis Distress

11 août 2026 mis à jour par: Kutahya Health Sciences University

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

100

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Turquie (Türkiye)
      • Simav, Turquie (Türkiye)
        • Recrutement
        • Simav Doc. Dr. Ismail Karakuyu State Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Nurse-Led Needs-Based Dialysis Self-Management Program
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.
Comportemental: Nurse-Led Needs-Based Dialysis Self-Management Program
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.
Comparateur actif: Routine Hemodialysis Care
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.
Comportemental: Routine Hemodialysis Care
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Dialysis-Related Distress Assessed by the Hemodialysis Distress Thermometer
Délai: 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.
Baseline, 6 weeks, and 18 weeks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Illness and Treatment Uncertainty Assessed by the Uncertainty in Chronic Dialysis Treatment Scale
Délai: Baseline, 6 weeks, and 18 weeks
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.
Baseline, 6 weeks, and 18 weeks
Treatment Adherence Assessed by the End-Stage Renal Disease Adherence Questionnaire
Délai: Baseline, 6 weeks, and 18 weeks
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.
Baseline, 6 weeks, and 18 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Kutahya Health Sciences University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 août 2026

Achèvement primaire (Estimé)

15 décembre 2026

Achèvement de l'étude (Estimé)

15 décembre 2026

Dates d'inscription aux études

Première soumission

30 juillet 2026

Première soumission répondant aux critères de contrôle qualité

30 juillet 2026

Première publication (Réel)

5 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

13 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

11 août 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • KSBU-HD-RCT-2026-01

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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