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

Study Overview
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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.

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

Conditions
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CKD - Chronic Kidney Disease

Intervention / Treatment
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* Behavioral: PACE intervention
* Behavioral: Usual care


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PACE intervention<br>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<br>* 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.<br>|
| Active Comparator: Control group<br>The control group receives usual care, which involves standard CKD education and consultation. | Behavioral: Usual care<br>* Nurses provide routine education and consultation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frailty | Assessing frailty using the Tilburg Frailty Indicator. | Before intervention, after initial intervention 3 months, and after intervention 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity | IPAQ-Taiwan | Before intervention, after initial intervention 3 months, and after intervention 6 months. | 
| Lifestyle | Health-promoting lifestyle behaviors-Taiwan version | Before intervention, after initial intervention and after intervention 6 months. | 
| Nutrition | Mini Nutritional Assessment Short-Form | Before intervention, after initial intervention 3 months, and after intervention 6 months. |