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

NCT ID: NCT06065501

Last Updated: 2025-06-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-19

Study Completion Date

2024-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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CKD - Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

PACE intervention

Intervention Type 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."

Control group

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

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type BEHAVIORAL

Nurses provide routine education and consultation

Interventions

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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."

Intervention Type BEHAVIORAL

Usual care

Nurses provide routine education and consultation

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cheng Kung University

OTHER

Sponsor Role lead

Responsible Party

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Miaofen Yen

Professor, Department of Nursing College of Medicine, National Cheng Kung University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status

Countries

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Taiwan

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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B-ER-109-494

Identifier Type: -

Identifier Source: org_study_id

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