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: Recruiting
• 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 (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: 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: Hongxia Shen, Phd; Phone Number: 13937118104; Email: hx_shen@163.com

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 from baseline to 3, 6 and 9 months after randomization	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

Outcome Measure	Measure Description	Time Frame
Change of blood pressure from baseline to 3, 6 and 9 months after randomization	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	The number of chronic kidney disease patients' and care providers' use of materials or system	Throughout the 9-month trial

Collaborators and Investigators

• Sponsor: Leiden University Medical Center
• Collaborators: The First Affiliated Hospital of Zhengzhou University
• Investigators: Principal Investigator: Niels Chavannes, Leiden University Medical Center

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.

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2024
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 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): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 9, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: self-management; chronic kidney disease; eHealth
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; 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