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Effects of a Nurse-Led Comprehensive Intervention on Frailty and Self-Management Behaviors in Patients Undergoing Peritoneal Dialysis

29. června 2026 aktualizováno: Zhi-fen Feng, Henan University

This study aims to evaluate the effects of a comprehensive nursing intervention based on the Integrated Theory of Health Behavior Change (ITHBC) on patients undergoing peritoneal dialysis with frailty syndrome.

The main questions it aims to answer include:

Can the ITHBC-based comprehensive nursing intervention improve patients' frailty status?

Can the intervention reduce patients' nutritional risk?

Can the intervention enhance patients' exercise self-efficacy, social support, and self-management behaviors?

Researchers will compare the ITHBC-based comprehensive nursing intervention (intervention group) with routine care (control group) to assess the effectiveness of the intervention program.

Participants:

The intervention group receives the ITHBC-based comprehensive nursing intervention (including personalized assessment, knowledge and belief reinforcement, skill development, goal setting and follow-up, and social support promotion) in addition to routine care for 3 months

The control group receives routine care (including admission education, standardized in-hospital health education, and monthly outpatient or telephone follow-up for 3 months)

Data are collected at baseline (T0), 1 month (T1), and 3 months (T2) post-intervention

Outcome measures include: frailty scores, nutritional risk scores, exercise self-efficacy scores, social support scores, and self-management behavior scores

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

72

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
    • Henan
      • Kaifeng, Henan, Čína, 475001
        • Henan University School of Nursing and Health Sciences

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:

  • age ≥ 18 years;
  • a diagnosis of end-stage renal disease with an estimated glomerular filtration rate of < 15 mL/min/1.73 m² ;
  • currently undergoing peritoneal dialysis with regular follow-up at the peritoneal dialysis clinic;
  • a score of ≥ 3 on the Fried Frailty Phenotype Scale;
  • provision of written informed consent and voluntary participation in this study.

Exclusion Criteria:

  • presence of concurrent severe primary diseases, including malignant tumors;
  • cognitive impairment or a diagnosed mental illness;
  • limb dysfunction that precluded cooperation with the intervention.

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: Sekvenční přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Experimental
Participants in this arm received a comprehensive nursing intervention based on the Integrated Theory of Health Behavior Change (ITHBC), in addition to routine care. The intervention consisted of five phases: personalized assessment, knowledge and belief reinforcement, skill and competency development, goal setting and follow-up, and social support promotion, delivered over a 3-month period.
Behaviorální: ITHBC-Based Comprehensive Nursing Intervention
A 3-month comprehensive nursing program based on the Integrated Theory of Health Behavior Change (ITHBC), consisting of five phases: (1) personalized assessment of frailty, nutritional status, physical activity, social support, and self-management capabilities; (2) knowledge and belief reinforcement through video-based and handbook-based education; (3) skill and competency development in nutrition management, multicomponent exercise training, and medication guidance; (4) goal setting and follow-up with individualized diet and exercise plans, biweekly visits in the first month and monthly visits thereafter; and (5) social support promotion involving healthcare professionals, family members, and peer support groups.
Aktivní komparátor: Control Group
Participants in this arm received routine care, including admission education, standardized in-hospital health education, and either outpatient or telephone follow-up once monthly for 3 months post-discharge.
Behaviorální: Routine Care
Routine nursing care for PD patients, including admission education, standardized in-hospital health education, and either outpatient or telephone follow-up once monthly for 3 months post-discharge.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Fried Frailty Phenotype Scale
Časové okno: Baseline, Month 1, Month 3
The Fried Frailty Phenotype Scale was developed by Fried et al. in 2001 and is recognized as the most widely used frailty assessment tool in the fields of gerontology and nephrology. This scale includes five components: unintentional weight loss, exhaustion, reduced grip strength, slow walking speed, and decreased physical activity. One point is assigned for each criterion that is met, yielding a total score that ranges from 0 to 5. A score of 0 indicates absence of frailty; scores of 1-2 suggest pre-frailty; and scores of 3 or more indicate frailty. The Cronbach's α coefficient for this scale was reported as 0.868.
Baseline, Month 1, Month 3
Chronic Kidney Disease Self-Management Scale
Časové okno: Baseline, Month 1, Month 3
The Chronic Kidney Disease Self-Management Scale (CKD-SM), which was developed by Yu P. and colleagues, evaluates the self-management behavior level of patients undergoing home-based peritoneal dialysis. This scale contains 31 items, which cover four domains: dietary management (12 items), treatment management (9 items), physical activity management (5 items), and psychosocial management (5 items). Each item was scored on a 4-point Likert scale, with response options ranging from "never" to "always" and corresponding scores ranging from 1 to 4. The total score ranges from 31 to 124, with higher scores indicating stronger self-management abilities. The overall Cronbach's α coefficient of this scale was reported as 0.902, and the test-retest reliability was reported as 0.898.
Baseline, Month 1, Month 3

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Nutritional Risk Screening Tool
Časové okno: Baseline, Month 1, Month 3
The Nutritional Risk Screening Tool (NRS-2002), which was developed by Kondrup and colleagues, is an evidence-based screening tool for nutritional risk. The total score is calculated as the sum of three components: a disease severity score, a nutritional status impairment score, and an age score. Both the disease severity score and the nutritional status impairment score range from 0 to 3 points, with 1 additional point being added for patients aged ≥ 70 years. The total score ranges from 0 to 7 points, and a score of ≥ 3 indicates the presence of nutritional risk. The Cronbach's α coefficient for this scale was reported as 0.760, and the criterion validity was reported as 0.670.
Baseline, Month 1, Month 3
Self-Efficacy for Exercise Scale
Časové okno: Baseline, Month 1, Month 3
The Self-Efficacy for Exercise Scale (SEE), which was developed by Resnick and colleagues and was adapted into a Chinese version by Lee and colleagues, assesses patients' confidence in their ability to adhere to an exercise regimen. This is a single-dimension scale consisting of nine items, each scored from 0 to 10, with response options ranging from "no confidence" to "very confident." The total score ranges from 0 to 90, with higher scores indicating greater patients' confidence in maintaining regular exercise. The Cronbach's α coefficient of this scale was reported as 0.75, and the content validity index was reported as 0.90
Baseline, Month 1, Month 3
Social Support Rating Scale
Časové okno: Baseline, Month 1, Month 3
The Social Support Rating Scale (SSRS), which was developed by Xiao S., assesses an individual's level of social support. This scale includes three dimensions (objective support, subjective support, and utilization of social support), comprising a total of ten items. The total score ranges from 12 to 66, with higher scores indicating a higher level of social support. The Cronbach's α coefficient for the overall scale was reported as 0.896, and the dimension-specific Cronbach's α coefficients were reported to range from 0.833 to 0.896.
Baseline, Month 1, Month 3
Laboratory Parameters
Časové okno: Baseline, Month 3
Serum albumin, hemoglobin, and serum total protein levels were measured to evaluate nutritional status and anemia in patients.
Baseline, Month 3

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Henan 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 2025

Primární dokončení (Aktuální)

30. června 2025

Dokončení studie (Aktuální)

30. září 2025

Termíny zápisu do studia

První předloženo

22. června 2026

První předloženo, které splnilo kritéria kontroly kvality

29. června 2026

První zveřejněno (Aktuální)

30. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

30. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

29. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • HUSOM2025-513

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

Individual participant data will not be shared due to ethical and privacy restrictions imposed by the Institutional Ethics Committee, and because informed consent obtained from participants did not include provisions for data sharing.

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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