Effects of a Nurse-Led Comprehensive Intervention on Frailty and Self-Management Behaviors in Patients Undergoing Peritoneal Dialysis
29 giugno 2026 aggiornato da: 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
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
72
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Henan
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Kaifeng, Henan, Cina, 475001
- Henan University School of Nursing and Health Sciences
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione sequenziale
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
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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.
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Comparatore attivo: 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.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Fried Frailty Phenotype Scale
Lasso di tempo: Baseline, Month 1, Month 3
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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.
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Baseline, Month 1, Month 3
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Chronic Kidney Disease Self-Management Scale
Lasso di tempo: Baseline, Month 1, Month 3
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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.
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Baseline, Month 1, Month 3
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Nutritional Risk Screening Tool
Lasso di tempo: Baseline, Month 1, Month 3
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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.
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Baseline, Month 1, Month 3
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Self-Efficacy for Exercise Scale
Lasso di tempo: Baseline, Month 1, Month 3
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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
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Baseline, Month 1, Month 3
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Social Support Rating Scale
Lasso di tempo: Baseline, Month 1, Month 3
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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.
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Baseline, Month 1, Month 3
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Laboratory Parameters
Lasso di tempo: Baseline, Month 3
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Serum albumin, hemoglobin, and serum total protein levels were measured to evaluate nutritional status and anemia in patients.
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Baseline, Month 3
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 marzo 2025
Completamento primario (Effettivo)
30 giugno 2025
Completamento dello studio (Effettivo)
30 settembre 2025
Date di iscrizione allo studio
Primo inviato
22 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
29 giugno 2026
Primo Inserito (Effettivo)
30 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
30 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
29 giugno 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- HUSOM2025-513
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano 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.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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