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

October 9, 2024 updated by: nhchavannes, Leiden University Medical Center
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Hongxia Shen
  • Phone Number: 00310633789207
  • Email: H.Shen@lumc.nl

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • The First Affiliated Hospital of Guangzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Medical Dashboard based self-management intervention
Chronic kidney disease patients in the intervention group will receive the usual care plus the tailored 'Medical Dashboard' based self-management intervention.
Behavioral: Medical Dashboard based self-management intervention
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.
No Intervention: Usual care services
Chronic 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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of chronic kidney disease self-management behavior using Chronic Kidney Disease Self-Management (CKD-SM) instrument from baseline to 3, 6 and 9 months after randomization
Time Frame: 0 month (baseline), 3 months after randomisation, 6 months after randomisation, 9 months after randomisation (endpoint)
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
0 month (baseline), 3 months after randomisation, 6 months after randomisation, 9 months after randomisation (endpoint)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of blood pressure from baseline to 3, 6 and 9 months after randomization
Time Frame: 0 month (baseline), 3 months after randomisation, 6 months after randomisation, 9 months after randomisation (endpoint)
Change of blood pressure will be measured from baseline to 3, 6 and 9 months after randomization. The blood pressure will be measured in mmHg with systolic blood pressure and diastolic blood pressure
0 month (baseline), 3 months after randomisation, 6 months after randomisation, 9 months after randomisation (endpoint)
Change of body weight from baseline to 3, 6 and 9 months after randomization
Time Frame: 0 month (baseline), 3 months after randomization, 6 months after randomization, 9 months after randomization (endpoint)
Change of body weight will be measured from baseline to 3, 6 and 9 months after randomization. The body weight will be measured in kilograms
0 month (baseline), 3 months after randomization, 6 months after randomization, 9 months after randomization (endpoint)
Change of glomerular filtration rate from baseline to 3, 6 and 9 months after randomization
Time Frame: 0 month (baseline), 3 months after randomisation, 6 months after randomisation, 9 months after randomisation (endpoint)
Glomerular filtration rate is a test used to check how well the kidneys are working. Change of glomerular filtration rate will be measured from baseline to 3, 6 and 9 months after randomization. The glomerular filtration rate will be measured in mL/min per 1.73 m2
0 month (baseline), 3 months after randomisation, 6 months after randomisation, 9 months after randomisation (endpoint)
Change of serum albumin from baseline to 3, 6 and 9 months after randomization
Time Frame: 0 month (baseline), 3 months after randomisation, 6 months after randomisation, 9 months after randomisation (endpoint)
Change of serum albumin will be measured from baseline to 3, 6 and 9 months after randomization. The serum albumin will be measured in g/L
0 month (baseline), 3 months after randomisation, 6 months after randomisation, 9 months after randomisation (endpoint)
Change of serum creatinine from baseline to 3, 6 and 9 months after randomization
Time Frame: 0 month (baseline), 3 months after randomisation, 6 months after randomisation, 9 months after randomisation (endpoint)
Change of serum creatinine will be measured from baseline to 3, 6 and 9 months after randomization. The serum creatinine will be measured in μmol/L
0 month (baseline), 3 months after randomisation, 6 months after randomisation, 9 months after randomisation (endpoint)
Change of number of complications patients have from baseline to 3, 6 and 9 months after randomization
Time Frame: 0 month (baseline), 3 months after randomisation, 6 months after randomisation, 9 months after randomisation (endpoint)
Change of number of complications patients have will be measured from baseline to 3, 6 and 9 months after randomization
0 month (baseline), 3 months after randomisation, 6 months after randomisation, 9 months after randomisation (endpoint)
Change of chronic kidney disease self-efficacy using Chronic Kidney Disease Self-efficacy (CKD-SE) scale from baseline to 3, 6 and 9 months after randomization
Time Frame: 0 month (baseline), 3 months after randomisation, 6 months after randomisation, 9 months after randomisation (endpoint)
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
0 month (baseline), 3 months after randomisation, 6 months after randomisation, 9 months after randomisation (endpoint)
Change of chronic kidney disease illness perception using Brief Illness Perception Questionnaire (BIPQ) from baseline to 9 months after randomization
Time Frame: 0 month (baseline), 9 months after randomisation (endpoint)
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
0 month (baseline), 9 months after randomisation (endpoint)
Change of chronic kidney disease anxiety and depression status using the Hospital Anxiety and Depression Scale (HADS) from baseline to 3, and 9 months after randomization
Time Frame: 0 month (baseline), 3 months after randomisation, 9 months after randomisation (endpoint)
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
0 month (baseline), 3 months after randomisation, 9 months after randomisation (endpoint)
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
Time Frame: 0 month (baseline), 9 months after randomisation (endpoint)
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
0 month (baseline), 9 months after randomisation (endpoint)
Hospital admission
Time Frame: 9 months after randomisation (endpoint)
The time to first acute hospital admission with an exacerbation of chronic kidney disease or death due to chronic kidney disease within nine months after randomisation
9 months after randomisation (endpoint)
Change of healthcare utilisation from 3 months after randomisation to 9 months after randomisation
Time Frame: 3 months after randomisation, 9 months after randomisation (endpoint)
The change of healthcare utilisation will be measured by using the number of hospitalisations and emergency room visits, primary and secondary care visits of patients
3 months after randomisation, 9 months after randomisation (endpoint)
Change of cost-benefit data from 3 months after randomisation to 9 months after randomisation
Time Frame: 3 months after randomisation, 9 months after randomisation (endpoint)
The cost-benefit analysis will be measured by using medical cost (e.g., cost of treatment, hospitalization rates minored as monetary terms), all costs delivering the interventions (e.g., materials used in the interventions)
3 months after randomisation, 9 months after randomisation (endpoint)
The proportion of chronic kidney disease patients and care professionals reached by the implementation of interventions
Time Frame: Throughout the 9-month trial
The proportion of chronic kidney disease patients and care professionals eligible to use our intervention program, excluded, invited, and enrolled in the intervention
Throughout the 9-month trial
The number of implementation completion tasks completed
Time Frame: Throughout the 9-month trial
The implementation completion tasks will be made as a checklist, and the number of implementations tasks finished will be checked
Throughout the 9-month trial
The number of chronic kidney disease patients' and care providers' use of the intervention
Time Frame: Throughout the 9-month trial
The number of chronic kidney disease patients' and care providers' use of materials or system
Throughout the 9-month trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Leiden University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The First Affiliated Hospital of Zhengzhou University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Niels Chavannes, Leiden University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 9, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 25, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 30, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201707040096

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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