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

NCT07677085 | Completed

• 1 other identifier: HUSOM2025-513
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peritoneal Dialysis (PD); Frailty Syndrome

Outcome Measures

Primary Outcomes (2)

• Fried Frailty Phenotype Scale

  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

  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

Secondary Outcomes (4)

• Nutritional Risk Screening Tool

  Baseline, Month 1, Month 3

• Self-Efficacy for Exercise Scale

  Baseline, Month 1, Month 3

• Social Support Rating Scale

  Baseline, Month 1, Month 3

• Laboratory Parameters

  Baseline, Month 3

Study Arms (2)

Experimental

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.

Behavioral: ITHBC-Based Comprehensive Nursing Intervention

Control Group

ACTIVE COMPARATOR

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.

Behavioral: Routine Care

Interventions

ITHBC-Based Comprehensive Nursing Intervention BEHAVIORAL

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.

Experimental

Routine Care BEHAVIORAL

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.

Control Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Henan University: lead

Study Sites (1)

Henan University School of Nursing and Health Sciences

Kaifeng, Henan, 475001, China

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: This is a quasi-experimental study using temporal (sequential) grouping to prevent inter-group contamination. Participants admitted between March and April 2025 were assigned to the control group, and those admitted between May and June 2025 were assigned to the intervention group.

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 30, 2026
• Study Start: March 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: September 30, 2025
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)