Back to resultsEffects of Personalized Actionable Connected Extensible (PACE) Interventions Among Patients With Chronic Kidney Disease
Primary Purpose
CKD - Chronic Kidney Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PACE intervention
Usual care
Sponsored by
About this trial
This is an interventional prevention trial for CKD - Chronic Kidney Disease
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PACE intervention
Control group
Arm Description
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.
The control group receives usual care, which involves standard CKD education and consultation.
Outcomes
Primary Outcome Measures
Frailty
Assessing frailty using the Tilburg Frailty Indicator.
Secondary Outcome Measures
Activity
IPAQ-Taiwan
Lifestyle
Health-promoting lifestyle behaviors-Taiwan version
Nutrition
Mini Nutritional Assessment Short-Form
Full Information
NCT ID
NCT06065501
First Posted
September 26, 2023
Last Updated
September 26, 2023
Sponsor
National Cheng Kung University
1. Study Identification
Unique Protocol Identification Number
NCT06065501
Brief Title
Effects of Personalized Actionable Connected Extensible (PACE) Interventions Among Patients With Chronic Kidney Disease
Official Title
Frailty Trajectories and Effects of Personalized Actionable Connected Extensible (PACE) Interventions Among Patients With Chronic Kidney Disease: A Longitudinal Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
February 29, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cheng Kung University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CKD - Chronic Kidney Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PACE intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The control group receives usual care, which involves standard CKD education and consultation.
Intervention Type
Behavioral
Intervention Name(s)
PACE intervention
Intervention Description
"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
Intervention Name(s)
Usual care
Intervention Description
Nurses provide routine education and consultation
Primary Outcome Measure Information:
Title
Frailty
Description
Assessing frailty using the Tilburg Frailty Indicator.
Time Frame
Before intervention, after initial intervention 3 months, and after intervention 6 months.
Secondary Outcome Measure Information:
Title
Activity
Description
IPAQ-Taiwan
Time Frame
Before intervention, after initial intervention 3 months, and after intervention 6 months.
Title
Lifestyle
Description
Health-promoting lifestyle behaviors-Taiwan version
Time Frame
Before intervention, after initial intervention and after intervention 6 months.
Title
Nutrition
Description
Mini Nutritional Assessment Short-Form
Time Frame
Before intervention, after initial intervention 3 months, and after intervention 6 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fang-Ru Yueh
Phone
886-6-2353535
Ext
5823
Email
t26011068@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Miaofen Yen
Phone
886-6-2353535
Ext
5823
Email
miaofen@mail.ncku.edu.tw
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Personalized Actionable Connected Extensible (PACE) Interventions Among Patients With Chronic Kidney Disease
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