Hemodialysis Health Management Model

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05281497
Collaborator
(none)
60
1
2
44
1.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Health platform
  • Behavioral: Social media
  • Other: exercise including an 18-minutes calisthenics
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
intervention group and control groupintervention group and control group
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Hemodialysis Health Management Model - the Application of Wearable Devices, Exercise and Nutritional Intervention
Actual Study Start Date :
Jul 1, 2019
Anticipated Primary Completion Date :
Apr 30, 2022
Anticipated Study Completion Date :
Feb 28, 2023

Arms and Interventions

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 including an 18-minutes calisthenics
exercise including 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).

Outcome Measures

Primary Outcome Measures

  1. Change of sit-to-stand-10 (STS-10) [baseline, week 4, week 8, week 12, week 16 and week 24]

    time to complete 10 sit-to-stand cycles

  2. Change of sit-to-stand-60 (STS-60) [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

  3. Change of 6-minute walking distance (6MWT) [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

  4. Change of hand grip strength [baseline, week 4, week 8, week 12, week 16 and week 24]

    the strength of hand drip measured by a dynamometer

Secondary Outcome Measures

  1. Change of KDQOL-SF [baseline, week 4, week 8, week 12, week 16 and week 24]

    Quality of life measured by the KDQOL-SF (dialysis version)

  2. Change of subjective global assessment (SGA) [baseline, week 4, week 8, week 12, week 16 and week 24]

    subjective global assessment for nutritional status

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wen-Yi Li Taipei Taiwan

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT05281497
Other Study ID Numbers:
  • 201812145RINA
First Posted:
Mar 16, 2022
Last Update Posted:
Mar 16, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by National Taiwan University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 16, 2022