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Health Coaching for Self-Management in Maintenance Hemodialysis Patients

29. června 2026 aktualizováno: Sirong Zhao, Anhui Medical University

Effects of Health Coaching on Self-Management Ability in Patients Undergoing Maintenance Hemodialysis: A Quasi-Experimental Study

This study is a quasi-experimental study designed to evaluate the effects of a health coaching intervention on self-management ability in patients undergoing maintenance hemodialysis. Patients receiving maintenance hemodialysis will be recruited from the hemodialysis center of the study hospital. Participants in the intervention group will receive a structured health coaching intervention in addition to routine care, while participants in the control group will receive routine care. The intervention aims to improve patients' self-management ability by providing individualized health education, goal setting, self-management guidance, follow-up support, and feedback. The main outcome of this study is self-management ability. Secondary outcomes may include self-efficacy, disease knowledge, and treatment adherence.

Přehled studie

Postavení

Aktivní, ne nábor

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

60

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Čína
    • Anhui
      • Hefei, Anhui, Čína, 230601
        • The Second Affiliated Hospital of Anhui Medical University

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  1. Patients aged ≥18 years who met the diagnostic criteria for ESRD according to the KDIGO 2012 Clinical Practice Guideline, namely a glomerular filtration rate of less than 15 mL/min/1.73 m².
  2. Patients who have received regular maintenance hemodialysis for at least 3 months, with a dialysis frequency of three times per week.
  3. Patients with a relatively stable clinical condition and no severe complications that may affect participation in the study.
  4. Patients who are conscious, have normal communication ability, and are able to cooperate in completing the study procedures and questionnaires.
  5. Patients who have no plan to change dialysis centers or travel for an extended period during the intervention period.
  6. Patients who voluntarily agree to participate in this study and provide informed consent.

Exclusion Criteria:

  1. Patients with severe cognitive impairment, mental disorder, or communication difficulties that prevent participation in the intervention or completion of questionnaires.
  2. Patients with severe acute illness or unstable clinical condition.
  3. Patients who are unable or unwilling to complete the 6-month intervention or follow-up.
  4. Patients participating in another similar intervention study during the same period.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: Nerandomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Health Coaching Group
Participants in this group will receive routine treatment and nursing care plus a structured 6-month health coaching intervention. The intervention will be delivered through face-to-face communication during dialysis and follow-up support via a WeChat group. It will follow eight steps: contact, observation, education, reinforcement, clarification, assistance, encouragement, and guidance. The main components include individualized assessment and establishment of electronic health records, hemodialysis-related health education, knowledge reinforcement using the teach-back method, individualized goal setting and action planning, health diary recording, family support, feedback on goal achievement, behavioral encouragement, emotional support, and long-term self-management guidance throughout the 6-month intervention period.
Behaviorální: Health Coaching
The health coaching intervention is a structured 6-month behavioral intervention delivered in addition to routine treatment and nursing care. It includes face-to-face communication during dialysis and follow-up support via a WeChat group. The intervention follows eight steps: contact, observation, education, reinforcement, clarification, assistance, encouragement, and guidance. Main components include individualized assessment, hemodialysis-related health education, teach-back-based knowledge reinforcement, individualized goal setting, action planning, health diary recording, family support, feedback on goal achievement, behavioral encouragement, emotional support, and long-term self-management guidance.
Jiný: Routine Care
Routine care includes regular maintenance hemodialysis, routine treatment and nursing care, basic health education, dietary and fluid management guidance, vascular access care guidance, medication guidance, and answers to patients' health-related questions as needed during the 6-month study period.
Aktivní komparátor: Routine Care Group
Participants in this group will receive routine treatment and nursing care provided by the hemodialysis center during the 6-month study period. Routine care includes regular maintenance hemodialysis, routine nursing assessment, basic health education, dietary and fluid management guidance, vascular access care guidance, medication guidance, and answers to patients' health-related questions as needed. Participants in this group will not receive the structured health coaching intervention.
Jiný: Routine Care
Routine care includes regular maintenance hemodialysis, routine treatment and nursing care, basic health education, dietary and fluid management guidance, vascular access care guidance, medication guidance, and answers to patients' health-related questions as needed during the 6-month study period.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Self-Management Ability
Časové okno: Baseline, 3 months after the intervention, and 6 months after the intervention
Self-management ability will be assessed using the Maintenance Hemodialysis Self-Management Scale at baseline, 3 months after the intervention, and 6 months after the intervention. The scale consists of 20 items and includes four dimensions: problem solving, self-care, partnership, and emotional management. Each item is scored on a 4-point Likert scale, ranging from 1 to 4. The total score ranges from 20 to 80, with higher scores indicating better self-management behavior. Changes in self-management ability across the three time points will be evaluated.
Baseline, 3 months after the intervention, and 6 months after the intervention

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Disease Knowledge
Časové okno: Baseline, 3 months after the intervention, and 6 months after the intervention
Disease knowledge will be assessed using the Maintenance Hemodialysis Patient Knowledge Questionnaire at baseline, 3 months after the intervention, and 6 months after the intervention. The questionnaire consists of 24 items covering five topics: anemia, diet and medication, kidney function, dialysis treatment, and rehabilitation. Each item is scored as 1 for a correct answer and 0 for an incorrect or "do not know" answer. The total score ranges from 0 to 24, with higher scores indicating a higher level of disease knowledge. Changes in disease knowledge across the three time points will be evaluated.
Baseline, 3 months after the intervention, and 6 months after the intervention
Self-Efficacy
Časové okno: Baseline, 3 months after the intervention, and 6 months after the intervention
Self-efficacy will be assessed using the Chronic Disease Self-Efficacy Scale at baseline, 3 months after the intervention, and 6 months after the intervention. The scale consists of 6 items and includes two dimensions: symptom management and common disease management. Each item is scored from 1 to 10, ranging from "not at all confident" to "totally confident." The total score is calculated as the mean score of the 6 items, ranging from 1 to 10. Higher scores indicate higher levels of self-efficacy. Changes in self-efficacy across the three time points will be evaluated.
Baseline, 3 months after the intervention, and 6 months after the intervention
Treatment Adherence
Časové okno: Baseline, 3 months after the intervention, and 6 months after the intervention
Treatment adherence will be assessed using the Maintenance Hemodialysis Patient Treatment Adherence Scale at baseline, 3 months after the intervention, and 6 months after the intervention. The scale consists of 23 items and includes four dimensions: dietary adherence, fluid adherence, medication adherence, and dialysis adherence. Each item is scored on a 5-point scale, with higher scores indicating better treatment adherence. Changes in treatment adherence across the three time points will be evaluated.
Baseline, 3 months after the intervention, and 6 months after the intervention

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Anhui Medical University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. března 2026

Primární dokončení (Odhadovaný)

31. srpna 2026

Dokončení studie (Odhadovaný)

31. srpna 2026

Termíny zápisu do studia

První předloženo

29. června 2026

První předloženo, které splnilo kritéria kontroly kvality

29. června 2026

První zveřejněno (Aktuální)

6. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

6. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

29. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • AHMU-HC-MHD-2026

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

Individual participant data will not be publicly shared due to privacy protection and ethical restrictions. The study involves patients undergoing maintenance hemodialysis, and the collected data include questionnaire responses and clinical information. To protect participant confidentiality, only aggregated and de-identified results will be reported in publications or presentations.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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