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

Primary Purpose

Chronic Kidney Disease Stage 1, Chronic Kidney Disease Stage 2, Chronic Kidney Disease stage3

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Mobile health application and social media
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease Stage 1

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Taiwan University Hospital Yunlin Branch

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change from Baseline Self-efficacy at 3 months
the score of self-efficacy questionnaire (score 0-200, the higher the better) in units
Change from Baseline Self-management at 3 months
the score of self-management questionnaire (score 16-64, the higher the better) in units
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
Change from Baseline Body composition at 3 month
weight and height will be combined to report BMI in kg/m^2
Change from Baseline Renal function at 3 months
estimated glomerular filtration rate in mL/min/1.73m2

Secondary Outcome Measures

Full Information

First Posted
June 7, 2020
Last Updated
August 22, 2021
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04617431
Brief Title
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

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 13, 2019 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease Stage 1, Chronic Kidney Disease Stage 2, Chronic Kidney Disease stage3, Chronic Kidney Disease stage4

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Mobile health application and social media
Intervention 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.
Primary Outcome Measure Information:
Title
Change from Baseline Self-efficacy at 3 months
Description
the score of self-efficacy questionnaire (score 0-200, the higher the better) in units
Time Frame
(1) baseline, (2) after the 90-day intervention
Title
Change from Baseline Self-management at 3 months
Description
the score of self-management questionnaire (score 16-64, the higher the better) in units
Time Frame
(1) baseline, (2) after the 90-day intervention
Title
Change from Baseline Quality of life score at 3 months
Description
the score of Kidney Disease Quality of Life (KDQOL-SF™) questionnaire (score 74-360, the higher the better) in units
Time Frame
(1) baseline, (2) after the 90-day intervention
Title
Change from Baseline Body composition at 3 month
Description
weight and height will be combined to report BMI in kg/m^2
Time Frame
(1) baseline, (2) after the 90-day intervention
Title
Change from Baseline Renal function at 3 months
Description
estimated glomerular filtration rate in mL/min/1.73m2
Time Frame
(1) baseline, (2) after the 90-day intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen-Yi Li
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital Yunlin Branch
City
Douliu
ZIP/Postal Code
640
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33320101
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.
Results Reference
derived

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

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