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

Frailty Trajectories and Effects of Personalized Actionable Connected Extensible (PACE) Interventions Among Patients With Chronic Kidney Disease: A Longitudinal Study

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

Study Overview

• Status: Completed
• Conditions: CKD - Chronic Kidney Disease
• Intervention / Treatment: Behavioral: PACE intervention; Behavioral: Usual care

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan
    • National Cheng Kung University Hospital

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PACE intervention; The intervention group (PACE intervention) utilizes mobile social network support, employing a LINE group to implement a personalized plan based on the TTM model for establishing a care program.	Behavioral: PACE intervention; "The PACE intervention involves using Line (technological devices) to establish a collaborative group with patients. The researchers will regularly provide reminders to chronic kidney disease patients regarding the importance of nutrition and exercise. They will also provide information on how to adhere to nutritional and exercise regimens, offering praise for consistent performance."
Active Comparator: Control group; The control group receives usual care, which involves standard CKD education and consultation.	Behavioral: Usual care; Nurses provide routine education and consultation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tilburg Frailty Indicator (TFI)	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.	Baseline, 3 months, and 6 months post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity Level Measured by IPAQ-Taiwan	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.	Baseline, 3 months, and 6 months post-intervention
Health-promoting Lifestyle Behaviors (HPLP-II, Taiwan Version)	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.	Baseline, 3 months, and 6 months post-intervention
Nutritional Status Measured by MNA-SF	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.	Baseline, 3 months, and 6 months post-intervention

Collaborators and Investigators

• Sponsor: National Cheng Kung University

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2023
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: September 26, 2023
• First Submitted That Met QC Criteria: September 26, 2023
• First Posted (Actual): October 4, 2023

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 9, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: B-ER-109-494

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

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