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

Henan University

Status: Completed

Conditions: Peritoneal Dialysis (PD); Frailty Syndrome

Treatments: Behavioral: ITHBC-Based Comprehensive Nursing Intervention; Behavioral: Routine Care

Study type: Interventional

Funder types: Other

Identifiers

NCT07677085

HUSOM2025-513

Details and patient eligibility

About

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

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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72 participants in 2 patient groups

Experimental

Experimental group

Description:

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.

Treatment:

Behavioral: ITHBC-Based Comprehensive Nursing Intervention

Control Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Routine Care