EHealth Based Self-management Intervention for Chronic Kidney Disease Care in China
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Medical Dashboard based self-management intervention.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Interventions
- 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.
Primary outcome measures
- 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)]
Secondary outcome measures (12)
- 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 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 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)]
- 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 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 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 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)]
- 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)]
- 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)]
- 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)]
- Hospital admission [Time frame: 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)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
China · 1 center
- The First Affiliated Hospital of Guangzhou Medical University — Guangzhou
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. PMID 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. PMID 33213398
Identifiers
NCT: NCT04212923 · 201707040096