AzTrials
AzTrials

Chronic Kidney DiseasesNCT04212923

eHealth Based Self-management Intervention for Chronic Kidney Disease Care in China

A study testing Medical Dashboard based self-management intervention in people with Chronic Kidney Diseases, run by Leiden University Medical Center at 1 site in China.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to develop an evidence-based tailored eHealth self-management intervention for patients with chronic kidney disease in China, and test the impact on implementation and effectiveness of interventions. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Kidney Diseases
What is being tested?
Medical Dashboard based self-management intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
9 Oct 2024to 30 Jul 2026
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients: (1) aged over 18 years old; (2) diagnosis of chronic kidney disease; (3) Chinese speaking.
  • Health care providers who work in the Department of Nephrology

Who cannot join

  • Individuals unable to participate due to physical or mental disabilities.
  • Individuals unable to write or read.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510000

Other trials in China

About this study

The purpose of this study is to develop an evidence-based tailored eHealth self-management intervention for patients with chronic kidney disease in China, and test the impact on implementation and effectiveness of interventions.

Read the detailed description

Interventions that support disease self-management (further referred to as 'self-management interventions') can have a significant impact on the health and quality of life of patients suffering from chronic conditions in general and chronic kidney disease (CKD) patients in specific. In the last decade, the use of electronic health (eHealth) technology in self-management interventions has become more and more popular. EHealth-based self-management interventions have been shown to improve health-related outcomes, such as blood pressure (BP) control and medication adherence, and found to be feasible and acceptable for CKD patients and care professionals. Hence, the use of eHealth self-management interventions for CKD patients has become increasingly popular. Knowledge of the implementation and effectivity of such interventions in China and other developing countries is, however, still lacking. Researchers from the Leiden University Medical Center (LUMC) developed 'Medical Dashboard', an eHealth intervention to help support and involve CKD patients in their disease self-management. We aim to tailor the evidence-based Dutch intervention 'Medical Dashboard' to the Chinese context and evaluate its implementation process and effectiveness.

Being tested
Medical Dashboard based self-management intervention
Keywords
eHealth, self-management, chronic kidney disease
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.

  • Medical Dashboard based self-management interventionBehavioural

    Before the start of the intervention, chronic kidney disease patients and care providers will receive a face-to-face training session on the use of Medical Dashboard. To avoid contamination, Medical Dashboard will only be made accessible for participants in the intervention group via a secure password-protected registration process.

Study groups in NCT04212923
Study groupRoleWhat they receive
Medical Dashboard based self-management interventionExperimentalChronic kidney disease patients in the intervention group will receive the usual care plus the tailored 'Medical Dashboard' based self-management intervention.
Receives: Behavioral: Medical Dashboard based self-management intervention
Usual care servicesNo interventionChronic kidney disease patients in the comparison group will receive usual care consisting of personalised in- and outpatient treatment based on symptoms experienced and disease severity, as outlined in the Kidney Disease Improving Global Outcomes (KDIGO).

What is being measured

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

  1. Change of chronic kidney disease self-management behavior using Chronic Kidney Disease Self-Management (CKD-SM) instrument

    The Chronic Kidney Disease Self-Management (CKD-SM) instrument with 29 items uses a four-point likert scale ranging from 1 (never) to 4 (always) to measure subjects' self-management behavior. Possible scores range from 29 to 116 points, with higher scores indicating better self-management behavior

    Measured: 0 month (baseline), 9 months after randomisation (endpoint)

Secondary outcomes (5)

  1. Change of number of complications patients

    Change of number of complications patients

    Measured: 0 month (baseline), 9 months after randomisation (endpoint)

  2. Change of chronic kidney disease self-efficacy using Chronic Kidney Disease Self-efficacy (CKD-SE) scale

    The Chronic Kidney Disease Self-efficacy (CKD-SE) scale is a 25-item self-administered scale that measures subjects' confidence. Responses range from no confidence (0) to the highest degree of confidence (10). Possible scores range from 0 to 250 points, with higher scores indicating greater levels of confidence

    Measured: 0 month (baseline), 9 months after randomisation (endpoint)

  3. Change of chronic kidney disease illness perception using Brief Illness Perception Questionnaire (BIPQ)

    The Brief Illness Perception Questionnaire (BIPQ) is a nine-item scale designed to rapidly assess the cognitive and emotional representations of illness. This scale consists of eight items related to illness perception. In addition, patients are asked to identify the three most important factors that they believe have caused their illness. All of the items except the causal question are rated using a 0 to 10 response scale. Higher scores indicate stronger perceptions along that dimension. The scores of items 3, 4, and 7 are calculated and expressed as reverse scores in this scale. Possible scores range from 0 to 80 points, with higher scores indicating a more threatening view of the illness

    Measured: 0 month (baseline), 9 months after randomisation (endpoint)

  4. Change of chronic kidney disease anxiety and depression status using the Hospital Anxiety and Depression Scale (HADS)

    Hospital Anxiety and Depression Scale (HADS) is used to determine the levels of anxiety and depression that a person is experiencing. It is a fourteen item scale that generates ordinal data. Seven items measure symptoms of anxiety and seven items measure symptoms of depression . Each item is coded from 0 to 3. Possible scores range from 0 to 21 points for sub-scale on anxiety or depression, with higher scores indicating greater levels of burden of anxiety or depression

    Measured: 0 month (baseline), 9 months after randomisation (endpoint)

  5. Change of chronic kidney disease quality of life using the Kidney Disease Quality of Life 36-item short-form survey (KDQOL-36) from baseline to 9 months after randomization

    The Kidney Disease Quality of Life 36-item short-form survey (KDQOL-36) is used to evaluate the health-related quality of life. It has 36 items. Possible scores range from 0 to 100 points, with higher scores indicating better health-related quality of life

    Measured: 0 month (baseline), 9 months after randomisation (endpoint)

Timeline

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

  1. First posted30 Dec 2019
  2. Study start9 Oct 2024
  3. Primary completion30 Jun 2026
  4. Study completion30 Jul 2026

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04212923
Sponsor's protocol ID
201707040096
Status last verified
Aug 2026
First submitted
18 Dec 2019
Last updated
26 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shen H, van der Kleij R, van der Boog PJM, Chavannes NH. Developing a Tailored eHealth Self-Management Intervention for Patients With Chronic Kidney Disease in China: Intervention Mapping Approach. JMIR Form Res. 2024 Jun 13;8:e48605. doi: 10.2196/48605.

    PubMed 38869943

  • Shen H, van der Kleij R, van der Boog PJM, Song X, Wang W, Zhang T, Li Z, Lou X, Chavannes N. Development and evaluation of an eHealth self-management intervention for patients with chronic kidney disease in China: protocol for a mixed-method hybrid type 2 trial. BMC Nephrol. 2020 Nov 19;21(1):495. doi: 10.1186/s12882-020-02160-6.

    PubMed 33213398

Questions about this trial

What is this clinical trial studying?

A study testing Medical Dashboard based self-management intervention in people with Chronic Kidney Diseases, run by Leiden University Medical Center at 1 site in China.

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 2 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 2026. 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 China. 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 of chronic kidney disease self-management behavior using Chronic Kidney Disease Self-Management (CKD-SM) instrument (time frame: 0 month (baseline), 9 months after randomisation (endpoint)). 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 NCT04212923, which also lists 2 linked publications.

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 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in