CompletedNot Applicable

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

China72 participantsStarted 2025-03-01

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Fried Frailty Phenotype Scale

Timeframe: Baseline, Month 1, Month 3

Chronic Kidney Disease Self-Management Scale

Timeframe: Baseline, Month 1, Month 3

Trial details

NCT IDNCT07677085

SponsorHenan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-30

View on ClinicalTrials.gov More Peritoneal Dialysis (PD) trials