Chronic Kidney Disease
Conditions
Keywords
chronic kidney disease, CKD, Symptom management, mobile app, eHealth, randomised feasibility trial, Vietnam
Brief 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.
Interventions
DEVICESymptom 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.
Sponsors
Griffith University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the nature of the study intervention, neither the patients nor the researchers can be blinded. However, the Outcome Assessor who collects study outcome data will be blinded to the group assignment.
Intervention model description
Eligible participants will be randomly assigned to either the intervention or control groups with allocation rate is 2:1 (2 in intervention group: 1 in control group)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* aged 18 years or above * are diagnosed with CKD grade 4 or grade 5 with or without haemodialysis * speak and read Vietnames * own a smartphone operating on Android with internet accessibility * agree to participate in this study.
Exclusion criteria
* cognitive impairment * psychological problems * terminal illness, such as cancer and advanced lung disease * acutely unwell * participating in another study during this trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the SAM program (missing data) | 3 time points (week 0, week 3, week 6) | Missing data is the percentage of data missing from the study's reporting. |
| Feasibility of the SAM program (retention rate) | Week 6 | The retention rate will be calculated by the number of participants who complete the study by dividing the number of participants who enrolled. The retention rate will be reported in percentage. |
| Feasibility of the SAM program (protocol adherence) | Week 6 | The protocol adherence is the number of participants in the allocated group who receive the assigned intervention. The protocol adherence will be reported in percentage |
| Feasibility of the SAM program (Eligibility) | Baseline (week 0) | The eligibility rate will be calculated by dividing the number of eligible participants by the number of screened participants. The eligibility rate will be reported in percentage. |
| Usability and Acceptability | Week 6 | The usability and acceptability will be assessed after participants complete 6 weeks of intervention using the Vietnamese version of the Mobile App Usability Questionnaire. This is an 18-item self-rated measure of the usability and acceptability of mobile apps. It has three subscales: 1) ease of use (5 items), 2) interface and satisfaction (7 items), and 3) usefulness (6 items). Each item is rated on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). The app's usability is determined by the total and average of all statements. The total score ranges from 18 to 126; the higher the overall total and average, the better the app's usability. |
| Feasibility of the SAM program (recruitment rate) | Baseline (week 0) | The recruitment rate will be calculated by dividing the number of recruited participants by the number of eligible participants and reported as percentage. |
| Feasibility of the SAM program (attrition rate) | Week 6 | The attrition rate will be determined by the number of participants who drop out before completing the study and reported as percentage. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-related quality of life | 3 time points (week 0, week 3, and week 6) | Health-related quality of life will be assessed using a self-reported EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) Vietnamese version. The tool includes five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The lower score of each dimensions, the better patient's health state. |
| Symptoms | 3 time points (week 0, week 3, and week 6) | The Vietnamese version of Integrated Palliative Care Outcome Scale - Renal (IPOS-Renal) will be used to assess symptoms of participants in both groups. It has 11 items covering five components: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The last four items are about information needs, satisfaction with healthcare and practical issues. Items scored on a Likert scale from 0 to 4 for increasing severity; total score reflects symptom burden. The higher total score, the higher symptom burden. |
Countries
Vietnam
Contacts
Primary ContactKhanh Linh Bui, Master of Science in Nursing
Outcome results
None listed