NCT07186361

Symptom Assessment And Management For Adults With CKD In Vietnam

Remote Symptom Assessment And Management Via Mobile App For Adults With Chronic Kidney Disease Living In Vietnam

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Griffith University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Adults with chronic kidney disease (CKD) have many symptoms that lower their quality of life and put a huge burden on the healthcare system. Recently, eHealth solutions have been introduced in chronic kidney disease care, helping with symptom management and improving patient outcomes. While symptom management via electronic health (eHealth) is emerging in other countries, it has not commenced in Vietnam. This study aims to develop and evaluate a remote symptom assessment and management program delivered through a mobile application for adults with CKD living in Vietnam to help them manage their symptoms. This is the first intervention program focusing on symptom assessment and management in Vietnam. By assessing and managing symptoms, adults with CKD can better self-manage their symptoms.

Detailed description

Adults with CKD experience a wide range of symptoms that significantly impact their health-related quality of life and place a huge burden on the healthcare system. Mobile health app-based interventions for symptom assessment and management have the potential to alleviate the burden of CKD and improve patient outcomes. This study aims to develop and test a Symptom Assessment and Management (SAM-CKD) program embedded into a mobile app for adults with CKD living in Vietnam. A feasibility randomised trial will be designed in designed following the Consolidated Standards of Reporting Trials (CONSORT) statement extension for randomised pilot and feasibility trials to evaluate the feasibility, usability, acceptability, and potential effectiveness of symptoms and health-related quality of life. Adults with CKD grade 4 or 5 (including those on dialysis) will be randomly assigned to either the intervention or control groups. Informed by the Theory of Symptom Management, the intervention includes three main components: a general introduction to CKD symptoms, a symptom tracker, and symptom management strategies. The intervention group will use the program for 6 weeks to self-manage their symptoms. Primary outcomes are feasibility and acceptability, measured by eligibility rate, recruitment rate, retention and attrition, protocol adherence, mobile app usability and acceptability. Secondary outcomes are changes in CKD symptoms and health-related quality of life measured by Integrated Palliative Outcome Scale - Renal (IPOS-Renal) and European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L), respectively. Data analysis involves descriptive and intention-to-treat analyses. The results will be reported following the CONSORT statement extension for randomised pilot and feasibility trials. Findings will provide empirical evidence about the feasibility, acceptability and initial effectiveness of mobile-based symptom management intervention and will inform the design of future large-scale effectiveness studies.

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
DEVICE	Symptom Assessment and Management Program (SAM-CKD) which is delivered via Smart Kidney mobile app	An intervention program delivered through a mobile app to support symptom assessment and management for adults with CKD. The SAM-CKD program has three components - introduction, symptom tracker and symptom management. A list of 17 common symptoms will be assessed. Users can self-assess symptoms and rate these according to the severity level (overwhelmingly, severely, moderately, slightly, and not at all). The SAM-CKD program will provide symptom management strategies based on symptoms reported by patients. The intervention's duration is 6 weeks.

Timeline

• Start date: 2025-11-01
• Primary completion: 2026-05-01
• Completion: 2027-03-01
• First posted: 2025-09-22
• Last updated: 2025-09-22

Locations

1 site across 1 country: Vietnam