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Chronic Kidney Disease Stage 1NCT04617431

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

A study testing Mobile health application and social media in people with Chronic Kidney Disease Stage 1 and Chronic Kidney Disease Stage 2, run by National Taiwan University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Mobile health application and social media
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
1 siteTaiwan
Study dates
13 Jan 2019to 31 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Taiwan University Hospital Yunlin Branch

    Douliu, 640

Other trials in Taiwan

About this study

Official title: 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.

Read the 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.

Being tested
Mobile health application and social media
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mobile health application and social mediaBehavioural

    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.

Study groups in NCT04617431
Study groupRoleWhat they receive
Intervention groupExperimentalThe 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.
Receives: Behavioral: Mobile health application and social media
Control groupNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline Self-efficacy at 3 months

    the score of self-efficacy questionnaire (score 0-200, the higher the better) in units

    Measured: (1) baseline, (2) after the 90-day intervention

  2. Change from Baseline Self-management at 3 months

    the score of self-management questionnaire (score 16-64, the higher the better) in units

    Measured: (1) baseline, (2) after the 90-day intervention

  3. 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

    Measured: (1) baseline, (2) after the 90-day intervention

  4. Change from Baseline Body composition at 3 month

    weight and height will be combined to report BMI in kg/m^2

    Measured: (1) baseline, (2) after the 90-day intervention

  5. Change from Baseline Renal function at 3 months

    estimated glomerular filtration rate in mL/min/1.73m2

    Measured: (1) baseline, (2) after the 90-day intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2020
  2. Study start13 Jan 2019
  3. Primary completion31 May 2020
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04617431
Sponsor's protocol ID
201808094RINB
Status last verified
May 2020
First submitted
7 Jun 2020
Last updated
26 Aug 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 33320101

Questions about this trial

What is this clinical trial studying?

A study testing Mobile health application and social media in people with Chronic Kidney Disease Stage 1 and Chronic Kidney Disease Stage 2, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Self-efficacy at 3 months (time frame: (1) baseline, (2) after the 90-day intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04617431, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021.

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