Clinical trial NCT04617431: Application of Wearable Devices to Build a Self-Management Model in Chronic Kidney Disease Patients
Official title: Application of Wearable Devices to Build a Self-Management Model in Chronic Kidney Disease Patients- Analysis of Healthcare Cost
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease Stage 1
Chronic Kidney Disease Stage 2
Chronic Kidney Disease stage3
Chronic Kidney Disease stage4
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-11-05
Enrollment: 49
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: Change from Baseline Self-efficacy at 3 months
timeFrame: (1) baseline, (2) after the 90-day intervention
measure: Change from Baseline Self-management at 3 months
timeFrame: (1) baseline, (2) after the 90-day intervention
measure: Change from Baseline Quality of life score at 3 months
timeFrame: (1) baseline, (2) after the 90-day intervention
measure: Change from Baseline Body composition at 3 month
timeFrame: (1) baseline, (2) after the 90-day intervention
measure: Change from Baseline Renal function at 3 months
timeFrame: (1) baseline, (2) after the 90-day intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Douliu
country: Taiwan
facility: National Taiwan University Hospital Yunlin Branch
Study officials:
affiliation: National Taiwan University Hospital
name: Wen-Yi Li
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.