Hemodialysis Health Management Model

June 16, 2024 updated by: National Taiwan University Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Wen-Yi Li

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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).
Behavioral: Social media
We built a LINE group to inspire the intervention group.
Other: Exercise training
exercise including walk and an 18-minutes calisthenics
Placebo Comparator: 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.
Behavioral: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of sit-to-stand-10 (STS-10)
Time Frame: baseline, week 4, week 8, week 12, week 16 and week 24
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)
Time Frame: baseline, week 4, week 8, week 12, week 16 and week 24
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)
Time Frame: baseline, week 4, week 8, week 12, week 16 and week 24
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
Time Frame: baseline, week 4, week 8, week 12, week 16 and week 24
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
Time Frame: baseline, week 4, week 8, week 12, week 16 and week 24
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)
Time Frame: baseline, week 4, week 8, week 12, week 16 and week 24
subjective global assessment for nutritional status
baseline, week 4, week 8, week 12, week 16 and week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Study Director: Wen-Yi Li, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Actual)

April 30, 2022

Study Completion (Actual)

February 28, 2023

Study Registration Dates

First Submitted

September 26, 2021

First Submitted That Met QC Criteria

March 15, 2022

First Posted (Actual)

March 16, 2022

Study Record Updates

Last Update Posted (Actual)

June 18, 2024

Last Update Submitted That Met QC Criteria

June 16, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201812145RINA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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