Effects of Personalized Actionable Connected Extensible (PACE) Interventions Among Patients With Chronic Kidney Disease

Not Applicable

Completed

• Conditions: CKD - Chronic Kidney Disease

• Registration Number: NCT06065501
• Lead Sponsor: National Cheng Kung University

Brief Summary

This is a randomized controlled trial study conducted on frail patients with chronic kidney disease(CKD).

Detailed Description

The study will be conducted on 120 frail patients with CKD, who will be divided into 2 groups: Group 1, consisting of 60 frail patients, will receive PACE intervention (based on mobile social network support) for 6 months. Group 2, comprising 60 frail patients, will receive usual CKD education and consultation for 6 months.

Study Timeline

• Study First Submitted: 2023-09-26
• Study First Submitted QC: 2023-09-26
• Study First Posted: 2023-10-04
• Study Start: 2023-10-19
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30
• Results First Submitted: 2025-05-20
• Status Verified: 2025-06
• Results First Submitted QC: 2025-06-09
• Last Update Submitted: 2025-06-09
• Results First Posted: 2025-06-26
• Last Update Posted: 2025-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Diagnosed with CKD stage 1 to 5
• Participants with pre-frail and frail conditions.
• Having access to a mobile phone and is capable of using mobile social network application (Line)

Exclusion Criteria

• Received renal replacement therapy
• Participants achieved TTM stage 5

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Tilburg Frailty Indicator (TFI)	Baseline, 3 months, and 6 months post-intervention	Frailty was measured using the Tilburg Frailty Indicator (TFI), a 15-item self-reported questionnaire assessing physical, psychological, and social domains. Total score ranges from 0 to 15, with higher scores indicating greater frailty.

Secondary Outcome Measures

Name	Time	Method
Physical Activity Level Measured by IPAQ-Taiwan	Baseline, 3 months, and 6 months post-intervention	Physical activity was assessed using the International Physical Activity Questionnaire - Taiwan version (IPAQ-Taiwan). Total physical activity score was calculated in MET-minutes/week, including walking, moderate, and vigorous intensity activities.
Health-promoting Lifestyle Behaviors (HPLP-II, Taiwan Version)	Baseline, 3 months, and 6 months post-intervention	Lifestyle behaviors were assessed using the HPLP-II, Taiwan version, including six subscales. Scores range from 52 to 208, with higher scores indicating more frequent health-promoting behaviors.
Nutritional Status Measured by MNA-SF	Baseline, 3 months, and 6 months post-intervention	Nutritional status was assessed using the Mini Nutritional Assessment - Short Form (MNA-SF), a 6-item tool scored 0-14. Higher scores indicate better nutritional status. A score ≥12 is considered normal. The Taiwan version was used.

Trial Locations

Locations (1)

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan