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

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

Study Overview

• Status: Completed
• Conditions: Frailty Syndrome; Peritoneal Dialysis (PD)
• Intervention / Treatment: Behavioral: ITHBC-Based Comprehensive Nursing Intervention; Behavioral: Routine Care

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
Active Comparator: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional Risk Screening Tool	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	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	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	Serum albumin, hemoglobin, and serum total protein levels were measured to evaluate nutritional status and anemia in patients.	Baseline, Month 3

Collaborators and Investigators

• Sponsor: Henan University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: June 29, 2026
• First Posted (Actual): June 30, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Frailty
• Other Study ID Numbers: HUSOM2025-513

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No