{"type":"trials","record":{"id":30376,"source_id":"clinicaltrials-gov","external_id":"NCT07677085","title":"Effects of a Nurse-Led Comprehensive Intervention on Frailty and Self-Management Behaviors in Patients Undergoing Peritoneal Dialysis","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","overall_status":"Completed","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Henan University","enrollment":72,"countries":["China"],"start_date":"2025-03-01","completion_date":"2025-09-30","last_update_date":"2026-06-30","source_url":"https://clinicaltrials.gov/study/NCT07677085","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:16:16.485702+00:00","last_seen_at":"2026-09-25T06:10:07.378+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"18 Years","comparator":"Control Group","organization":"Henan University","interventions":["ITHBC-Based Comprehensive Nursing Intervention","Routine Care"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Fried Frailty Phenotype Scale — Baseline, Month 1, Month 3","Chronic Kidney Disease Self-Management Scale — Baseline, Month 1, Month 3","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"],"design_description":"NON RANDOMIZED · SEQUENTIAL · SUPPORTIVE CARE · DOUBLE","source_has_results":false},"controlled_terms":["Peritoneal Dialysis (PD)","Frailty Syndrome","ITHBC-Based Comprehensive Nursing Intervention","Routine Care"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Title contains controlled term: frailty.","quality_checked_at":"2026-09-25T06:10:20.034853+00:00","duplicate_cluster_key":"id:nct07677085","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2025-03-01 to 2025-09-30","comparator":"Control Group","confidence":"structured-source","population":"ALL · 18 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:10:07.417Z","intervention":["ITHBC-Based Comprehensive Nursing Intervention","Routine Care"],"participants":72,"study_design":"NON RANDOMIZED · SEQUENTIAL · SUPPORTIVE CARE · DOUBLE","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Fried Frailty Phenotype Scale — Baseline, Month 1, Month 3","Chronic Kidney Disease Self-Management Scale — Baseline, Month 1, Month 3","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"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"frailty","is_published":true,"match_reasons":["Title contains controlled term: frailty.","Abstract contains controlled term: frailty.","Source terminology contains: frailty.","Title supplies longevity context: frailty, frail.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Frailty","slug":"frailty"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/30376","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}