Application of Wearable Devices to Build a Self-Management Model in Chronic Kidney Disease Patients

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National Taiwan University

Status

Completed

Conditions

Chronic Kidney Disease stage3
Chronic Kidney Disease stage4
Chronic Kidney Disease Stage 2
Chronic Kidney Disease Stage 1

Treatments

Behavioral: Mobile health application and social media

Study type

Interventional

Funder types

Other

Identifiers

NCT04617431
201808094RINB

Details and patient eligibility

About

Aim: By application of wearable devices and health management platform to build self-management model in CKD patients and analyze the cost of healthcare. Material and Methods: The investigators plan to recruit 60 CKD patients as trial subjects. The intervention group is composed of 30 participants, and the control group 30 participants. The intervention group received intervention with wearable devices and health management platform for 90 days. Patients record 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 also create a LINE group to encourage exercise in the experimental group. The investigators compare the scores of self-management sheet and physical and laboratory examinations before and after the intervention. The investigators also analyze the cost of healthcare within 180 days.

Full description

Background: End stage renal disease (ESRD) is a global public health issue. The dialysis therapy brings huge economic burden to many countries. According to the report of 2015 United States Renal Data System (USRDS), the incidence rate of ESRD is 458 people per million populations. And the prevalence rate is 3,138 people per million populations, which is the highest one in the world. Chronic kidney disease (CKD) can be classified into five stages according to glomerular filtration rate. Whatever the stage it is, patients should keep healthy habits about diet and exercise and good adherence to medication. 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 build self-management model in CKD patients and analyze the cost of healthcare. Material and Methods: The investigators plan to recruit 60 CKD patients as trial subjects. The intervention group is composed of 30 participants, and the control group 30 participants. The intervention group received intervention with wearable devices and health management platform for 90 days. 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 also create a LINE group to encourage exercise in the experimental group. The investigators compare the scores of self-management sheet and physical and laboratory examinations before and after the intervention. The investigators also analyze the cost of healthcare within 180 days.

Enrollment

49 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

  • Chronic kidney disease stage 1-4
  • Agree to partake in the study signed informed consent forms for participation.

Exclusion Criteria:

  • Can not use a smartphone
  • Have impaired walking capacity
  • Psychiatric disorder
  • Have been hospitalized during the previous three months

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

49 participants in 2 patient groups

Intervention group
Experimental group
Description:
The intervention involved reminding the intervention group to upload their dietary diary every day. The researchers were trained by a dietitian and provided suggestions about diet and exercise to the intervention group. "LINE " is a mobile app operated by LINE Corporation. All users can use texts, images, video, and audio for contact at any time. A LINE group was created to deliver medical knowledge of diet and exercise. Each of the messages were guided by a diet manual for kidney disease (edited by Department of Dietetics, National Taiwan University Hospital Yunlin Branch). The intervention group also asked questions about CKD management, and a teleconsultation of health information was provided. A daily target of 7,500 steps was set and used to emphasize the correct concepts about exercise. Participants were inspired in the intervention group if someone achieved the target number of steps.
Treatment:
Behavioral: Mobile health application and social media
Control group
No Intervention group
Description:
The participants of control group had a wearable device and could upload their dietary diary to the health management platform every day. But no "LINE" group was created, and no reminding.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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