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

NCT04212923 | Recruiting

• 1 other identifier: 201707040096
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases

Keywords

eHealth; self-management; chronic kidney disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Change of blood pressure 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 body weight from baseline to 3, 6 and 9 months after randomization

  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

  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

  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

  0 month (baseline), 3 months after randomisation, 6 months after randomisation, 9 months after randomisation (endpoint)

Study Arms (2)

Medical Dashboard based self-management intervention

EXPERIMENTAL

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

Usual care services

NO INTERVENTION

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).

Interventions

Medical Dashboard based self-management intervention BEHAVIORAL

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.

Medical Dashboard based self-management intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Leiden University Medical Center: lead
• The First Affiliated Hospital of Zhengzhou University: collaborator

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (2)

• 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 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Niels Chavannes

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongxia Shen

CONTACT

00310633789207; H.Shen@lumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor of Primary Care Medicine

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: December 30, 2019
• Study Start: October 9, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: October 15, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)