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

NCT06065501 | Completed Results

• 1 other identifier: B-ER-109-494
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

CKD - Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Physical Activity Level Measured by IPAQ-Taiwan

  Baseline, 3 months, and 6 months post-intervention

• Health-promoting Lifestyle Behaviors (HPLP-II, Taiwan Version)

  Baseline, 3 months, and 6 months post-intervention

• Nutritional Status Measured by MNA-SF

  Baseline, 3 months, and 6 months post-intervention

Study Arms (2)

PACE intervention

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

The control group receives usual care, which involves standard CKD education and consultation.

Behavioral: Usual care

Interventions

PACE intervention BEHAVIORAL

"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."

PACE intervention

Usual care BEHAVIORAL

Nurses provide routine education and consultation

Control group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Received renal replacement therapy
• Participants achieved TTM stage 5

Sponsors & Collaborators

• National Cheng Kung University: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Taiwan

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Professor Miaofen Yen / Professor of Nursing department
• Organization: National Cheng Kung University

miaofen@mail.ncku.edu.tw

886-6-2353535

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Nursing College of Medicine, National Cheng Kung University

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 4, 2023
• Study Start: October 19, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: June 26, 2025
• Results First Posted: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)