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

NCT04617431 | Completed DMC

• 1 other identifier: 201808094RINB
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Mobile health application and social media BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital Yunlin Branch

Douliu, 640, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 33320101 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wen-Yi Li

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2020
• First Posted: November 5, 2020
• Study Start: January 13, 2019
• Primary Completion: May 31, 2020
• Study Completion: December 31, 2020
• Last Updated: August 26, 2021

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)