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

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: Completed
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Behavioral: Medical Dashboard based self-management intervention

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: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • The Second Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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	0 month (baseline), 9 months after randomisation (endpoint)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	0 month (baseline), 9 months after randomisation (endpoint)
Change of number of complications patients	Change of number of complications patients	0 month (baseline), 9 months after randomisation (endpoint)
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	0 month (baseline), 9 months after randomisation (endpoint)
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	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)	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), 9 months after randomisation (endpoint)

Collaborators and Investigators

• Sponsor: Leiden University Medical Center
• Collaborators: The First Affiliated Hospital of Zhengzhou University
• Investigators: Principal Investigator: Hongxia Shen, Guangzhou Medical University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2024
• Primary Completion (Actual): June 30, 2026
• Study Completion (Actual): July 30, 2026

Study Registration Dates

• First Submitted: December 18, 2019
• First Submitted That Met QC Criteria: December 25, 2019
• First Posted (Actual): December 30, 2019

Study Record Updates

• Last Update Posted (Actual): August 26, 2026
• Last Update Submitted That Met QC Criteria: August 24, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: self-management; chronic kidney disease; eHealth
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic
• Other Study ID 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