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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease stage4; Chronic Kidney Disease stage3; Chronic Kidney Disease Stage 2; Chronic Kidney Disease Stage 1
• Intervention / Treatment: Behavioral: Mobile health application and social media

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Douliu, Taiwan, 640
    • National Taiwan University Hospital Yunlin Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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.	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.
No Intervention: Control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Wen-Yi Li, National Taiwan University Hospital

Publications and helpful links

General Publications

• Li WY, Chiu FC, Zeng JK, Li YW, Huang SH, Yeh HC, Cheng BW, Yang FJ. Mobile Health App With Social Media to Support Self-Management for Patients With Chronic Kidney Disease: Prospective Randomized Controlled Study. J Med Internet Res. 2020 Dec 15;22(12):e19452. doi: 10.2196/19452.

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2019
• Primary Completion (Actual): May 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: June 7, 2020
• First Submitted That Met QC Criteria: November 1, 2020
• First Posted (Actual): November 5, 2020

Study Record Updates

• Last Update Posted (Actual): August 26, 2021
• Last Update Submitted That Met QC Criteria: August 22, 2021
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 201808094RINB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No