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

Not Applicable

Recruiting

• Conditions: CKD - Chronic Kidney Disease
• Interventions: Behavioral: PACE intervention; Behavioral: Usual care

• 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
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-21
• Last Update Posted: 2024-03-22
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: RECRUITING
• 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

Arm && Interventions

Group	Intervention	Description
PACE intervention	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.
Control group	Usual care	The control group receives usual care, which involves standard CKD education and consultation.

Primary Outcome Measures

Name	Time	Method
Frailty	Before intervention, after initial intervention 3 months, and after intervention 6 months.	Assessing frailty using the Tilburg Frailty Indicator.

Secondary Outcome Measures

Name	Time	Method
Lifestyle	Before intervention, after initial intervention and after intervention 6 months.	Health-promoting lifestyle behaviors-Taiwan version
Activity	Before intervention, after initial intervention 3 months, and after intervention 6 months.	IPAQ-Taiwan
Nutrition	Before intervention, after initial intervention 3 months, and after intervention 6 months.	Mini Nutritional Assessment Short-Form

Trial Locations

Locations (1)

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan