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

Chronic Kidney Disease stage4 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04617431
• Other study ID #: 201808094RINB
• Status: Completed
• Phase: N/A
• Start date: January 13, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2020
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease Stage 1
• Chronic Kidney Disease Stage 2
• Chronic Kidney Disease stage3
• Chronic Kidney Disease stage4
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• Mobile health application and social media
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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital Yunlin Branch	Douliu

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Self-efficacy at 3 months	the score of self-efficacy questionnaire (score 0-200, the higher the better) in units	(1) baseline, (2) after the 90-day intervention
Primary	Change from Baseline Self-management at 3 months	the score of self-management questionnaire (score 16-64, the higher the better) in units	(1) baseline, (2) after the 90-day intervention
Primary	Change from Baseline Quality of life score at 3 months	the score of Kidney Disease Quality of Life (KDQOL-SF™) questionnaire (score 74-360, the higher the better) in units	(1) baseline, (2) after the 90-day intervention
Primary	Change from Baseline Body composition at 3 month	weight and height will be combined to report BMI in kg/m^2	(1) baseline, (2) after the 90-day intervention
Primary	Change from Baseline Renal function at 3 months	estimated glomerular filtration rate in mL/min/1.73m2	(1) baseline, (2) after the 90-day intervention