Hemodialysis Health Management Model

Study Overview
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Brief Summary
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Aim: By application of wearable devices and health management platform to strengthen physical activity and improved life quality in hemodialysis patients.

Detailed Description
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Background: End stage renal disease (ESRD) is a global public health issue. The dialysis therapy brings huge economic burden to many countries. If patients are able to monitor their lifestyle, it not only promotes health, but also reduces the cost of health care. Aim: By application of wearable devices and health management platform to strengthen physical activity and improved life quality in hemodialysis patients. Material and Methods: The investigators plan to recruit 30 CKD patients as trial subjects for intervention. The intervention included wearable devices and health management platform for 24 weeks. Patients record their own diet diary by a smartphone application, and their exercise-related data are collected by wearable devices. Then, all the collected information will be upload to health management platform. The investigators compare physical and laboratory examinations before and after the intervention.

Official Title
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Hemodialysis Health Management Model - the Application of Wearable Devices, Exercise and Nutritional Intervention

Conditions
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Physical Inactivity, Nutritional Wasting

Intervention / Treatment
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* Behavioral: Health platform
* Behavioral: Social media
* Other: exercise including an 18-minutes calisthenics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 20 years and older diagnosis of ESRD receiving maintenance HD for more than 3 months Exclusion Criteria: inability to use a smartphone impaired walking capacity having a psychiatric disorder any hospitalization during the previous 3 months. has been changing dialysis modality or receiving renal transplantation

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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: Treatment
Intervention Model: Parallel Assignment
Interventional Model Description: intervention group and control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Each participant was provided with a wearable device. Each participant downloaded an app (WowGoHealth app) to connect with the health management platform. All participants were taught to record a dietary diary (taking photos of meals) using a smartphone application. All collected information was uploaded to the health management platform. For the intervention group, we encouraged exercise including an 18-minutes calisthenics. We also built a LINE group to inspire the intervention group. | Behavioral: Health platform<br>* Each participant was provided with a wearable device (a Heart Rate Smart Wristband, GSH405-B6, Golden Smart Home Technology Corporation). Each participant downloaded an app (WowGoHealth app) to connect with the health management platform (GSH AI health platform). Participants' exercise-related data, including number of steps walked, distance, consumed calories, and heart rate, were collected by the wearable devices. All participants were taught to record a dietary diary (taking photos of meals) using a smartphone application. All collected information was uploaded to the health management platform. For the intervention group, we encouraged exercise including an 18-minutes calisthenics made by the Health Promotion Administration, Ministry of Health and Welfare (https://www.youtube.com/watch?v=r3xJW-b2tZY).<br>Behavioral: Social media<br>* We built a LINE group to inspire the intervention group.<br>Other: exercise including an 18-minutes calisthenics<br>* exercise including an 18-minutes calisthenics<br>|
| Placebo Comparator: Control group<br>Each participant was provided with a wearable device. Each participant downloaded an app (WowGoHealth app) to connect with the health management platform. All participants were taught to record a dietary diary (taking photos of meals) using a smartphone application. We did not encourage exercise or build a LINE group. | Behavioral: Health platform<br>* Each participant was provided with a wearable device (a Heart Rate Smart Wristband, GSH405-B6, Golden Smart Home Technology Corporation). Each participant downloaded an app (WowGoHealth app) to connect with the health management platform (GSH AI health platform). Participants' exercise-related data, including number of steps walked, distance, consumed calories, and heart rate, were collected by the wearable devices. All participants were taught to record a dietary diary (taking photos of meals) using a smartphone application. All collected information was uploaded to the health management platform. For the intervention group, we encouraged exercise including an 18-minutes calisthenics made by the Health Promotion Administration, Ministry of Health and Welfare (https://www.youtube.com/watch?v=r3xJW-b2tZY).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of sit-to-stand-10 (STS-10) | time to complete 10 sit-to-stand cycles | baseline, week 4, week 8, week 12, week 16 and week 24 | 
| Change of sit-to-stand-60 (STS-60) | the number of repetitions of sit-to-stand cycles achieved in 60 seconds | baseline, week 4, week 8, week 12, week 16 and week 24 | 
| Change of 6-minute walking distance (6MWT) | the distance the participants walk as fast as they could for 6 minutes on a flat 30-meter track | baseline, week 4, week 8, week 12, week 16 and week 24 | 
| Change of hand grip strength | the strength of hand drip measured by a dynamometer | baseline, week 4, week 8, week 12, week 16 and week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of KDQOL-SF | Quality of life measured by the KDQOL-SF (dialysis version) | baseline, week 4, week 8, week 12, week 16 and week 24 | 
| Change of subjective global assessment (SGA) | subjective global assessment for nutritional status | baseline, week 4, week 8, week 12, week 16 and week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis, Wearable device, Health management platform