Remote Symptom Assessment And Management Via Mobile App For Adults With Chronic Kidney Disease Living In Vietnam
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Feasibility of the SAM program (retention rate)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •cognitive impairment
- •psychological problems
- •terminal illness, such as cancer and advanced lung disease
- •acutely unwell
- •participating in another study during this trial
结局指标
主要结局
Feasibility of the SAM program (retention rate)
时间窗: 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)
时间窗: 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 (missing data)
时间窗: 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 (Eligibility)
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: Week 6
The attrition rate will be determined by the number of participants who drop out before completing the study and reported as percentage.
Feasibility of the SAM program (Eligibility)
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: Week 6
The attrition rate will be determined by the number of participants who drop out before completing the study and reported as percentage.
Feasibility of the SAM program (retention rate)
时间窗: 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)
时间窗: 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 (missing data)
时间窗: 3 time points (week 0, week 3, week 6)
Missing data is the percentage of data missing from the study's reporting.
次要结局
- Symptoms(3 time points (week 0, week 3, and week 6))
- Health-related quality of life(3 time points (week 0, week 3, and week 6))
- Symptoms(3 time points (week 0, week 3, and week 6))
- Health-related quality of life(3 time points (week 0, week 3, and week 6))
研究者
Khanh Linh Bui
PhD Candidate
Griffith University