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Hemodialysis Health Management Model

Primary Purpose

Physical Inactivity, Nutritional Wasting

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Health platform
Social media
exercise including an 18-minutes calisthenics
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Physical Inactivity focused on measuring Hemodialysis, Wearable device, Health management platform

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wen-Yi Li

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change of sit-to-stand-10 (STS-10)
time to complete 10 sit-to-stand cycles
Change of sit-to-stand-60 (STS-60)
the number of repetitions of sit-to-stand cycles achieved in 60 seconds
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
Change of hand grip strength
the strength of hand drip measured by a dynamometer

Secondary Outcome Measures

Change of KDQOL-SF
Quality of life measured by the KDQOL-SF (dialysis version)
Change of subjective global assessment (SGA)
subjective global assessment for nutritional status

Full Information

First Posted
September 26, 2021
Last Updated
June 30, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05281497
Brief Title
Hemodialysis Health Management Model
Official Title
Hemodialysis Health Management Model - the Application of Wearable Devices, Exercise and Nutritional Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
February 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Inactivity, Nutritional Wasting
Keywords
Hemodialysis, Wearable device, Health management platform

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
intervention group and control group
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health platform
Intervention Description
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
Intervention Name(s)
Social media
Intervention Description
We built a LINE group to inspire the intervention group.
Intervention Type
Other
Intervention Name(s)
exercise including an 18-minutes calisthenics
Intervention Description
exercise including an 18-minutes calisthenics
Primary Outcome Measure Information:
Title
Change of sit-to-stand-10 (STS-10)
Description
time to complete 10 sit-to-stand cycles
Time Frame
baseline, week 4, week 8, week 12, week 16 and week 24
Title
Change of sit-to-stand-60 (STS-60)
Description
the number of repetitions of sit-to-stand cycles achieved in 60 seconds
Time Frame
baseline, week 4, week 8, week 12, week 16 and week 24
Title
Change of 6-minute walking distance (6MWT)
Description
the distance the participants walk as fast as they could for 6 minutes on a flat 30-meter track
Time Frame
baseline, week 4, week 8, week 12, week 16 and week 24
Title
Change of hand grip strength
Description
the strength of hand drip measured by a dynamometer
Time Frame
baseline, week 4, week 8, week 12, week 16 and week 24
Secondary Outcome Measure Information:
Title
Change of KDQOL-SF
Description
Quality of life measured by the KDQOL-SF (dialysis version)
Time Frame
baseline, week 4, week 8, week 12, week 16 and week 24
Title
Change of subjective global assessment (SGA)
Description
subjective global assessment for nutritional status
Time Frame
baseline, week 4, week 8, week 12, week 16 and week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen-Yi Li
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Wen-Yi Li
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

Hemodialysis Health Management Model

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