Clinical trial NCT04212923: EHealth Based Self-management Intervention for Chronic Kidney Disease Care in China
Official title: EHealth Based Self-management Intervention for Chronic Kidney Disease Care in China
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Diseases
Keywords: eHealth
self-management
chronic kidney disease
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Zhengzhou University
First posted: 2019-12-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

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.

Primary outcomes:
measure: 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
timeFrame: 0 month (baseline), 3 months after randomisation, 6 months after randomisation, 9 months after randomisation (endpoint)
Secondary outcomes:
measure: Change of blood pressure from baseline to 3, 6 and 9 months after randomization
timeFrame: 0 month (baseline), 3 months after randomisation, 6 months after randomisation, 9 months after randomisation (endpoint)
measure: Change of body weight from baseline to 3, 6 and 9 months after randomization
timeFrame: 0 month (baseline), 3 months after randomization, 6 months after randomization, 9 months after randomization (endpoint)
measure: Change of glomerular filtration rate from baseline to 3, 6 and 9 months after randomization
timeFrame: 0 month (baseline), 3 months after randomisation, 6 months after randomisation, 9 months after randomisation (endpoint)
measure: Change of serum albumin from baseline to 3, 6 and 9 months after randomization
timeFrame: 0 month (baseline), 3 months after randomisation, 6 months after randomisation, 9 months after randomisation (endpoint)
measure: Change of serum creatinine from baseline to 3, 6 and 9 months after randomization
timeFrame: 0 month (baseline), 3 months after randomisation, 6 months after randomisation, 9 months after randomisation (endpoint)
measure: Change of number of complications patients have from baseline to 3, 6 and 9 months after randomization
timeFrame: 0 month (baseline), 3 months after randomisation, 6 months after randomisation, 9 months after randomisation (endpoint)
measure: 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
timeFrame: 0 month (baseline), 3 months after randomisation, 6 months after randomisation, 9 months after randomisation (endpoint)
measure: Change of chronic kidney disease illness perception using Brief Illness Perception Questionnaire (BIPQ) from baseline to 9 months after randomization
timeFrame: 0 month (baseline), 9 months after randomisation (endpoint)
measure: 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
timeFrame: 0 month (baseline), 3 months after randomisation, 9 months after randomisation (endpoint)
measure: 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
timeFrame: 0 month (baseline), 9 months after randomisation (endpoint)
measure: Hospital admission
timeFrame: 9 months after randomisation (endpoint)
measure: Change of healthcare utilisation from 3 months after randomisation to 9 months after randomisation
timeFrame: 3 months after randomisation, 9 months after randomisation (endpoint)
measure: Change of cost-benefit data from 3 months after randomisation to 9 months after randomisation
timeFrame: 3 months after randomisation, 9 months after randomisation (endpoint)
measure: The proportion of chronic kidney disease patients and care professionals reached by the implementation of interventions
timeFrame: Throughout the 9-month trial
measure: The number of implementation completion tasks completed
timeFrame: Throughout the 9-month trial
measure: The number of chronic kidney disease patients' and care providers' use of the intervention
timeFrame: Throughout the 9-month trial
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
affiliation: Leiden University Medical Center
name: Niels Chavannes
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.