Hemodialysis Health Management Model

NCT ID: NCT05281497

Last Updated: 2024-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2023-02-28

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.

Conditions

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Physical Inactivity Nutritional Wasting

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

intervention group and control group
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group

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.

Group Type EXPERIMENTAL

Health platform

Intervention Type BEHAVIORAL

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).

Social media

Intervention Type BEHAVIORAL

We built a LINE group to inspire the intervention group.

Exercise training

Intervention Type OTHER

exercise including walk and an 18-minutes calisthenics

Control group

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.

Group Type PLACEBO_COMPARATOR

Health platform

Intervention Type BEHAVIORAL

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).

Interventions

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Health platform

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).

Intervention Type BEHAVIORAL

Social media

We built a LINE group to inspire the intervention group.

Intervention Type BEHAVIORAL

Exercise training

exercise including walk and an 18-minutes calisthenics

Intervention Type OTHER

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wen-Yi Li

Role: STUDY_DIRECTOR

National Taiwan University Hospital

Locations

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Wen-Yi Li

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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201812145RINA

Identifier Type: -

Identifier Source: org_study_id

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