An interventional study of Standard care and Experimental in Urinary Calculi, Postoperative Care and Chronic Disease Prevention, sponsored by The University of Hong Kong. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-25.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Prevention
The goal of this clinical trial is to learn Whether the WeChat-based applet works to prevent urinary calculi for postoperative patients. The main questions it aims to answer are:
Dose the WeChat-based applet intervention increase the amount of fluid intake and urine output? Researchers will compare the WeChat-based applet intervention to a usual care to see if the WeChat-based applet works to prevent urinary calculi occurence.
Participants will:
The study outcomes will be reported to adhere to the guidelines outlined in the Consolidated Standards of Reporting Trials (CONSORT) 2010 statements. Reporting measures of central tendency (mean, median) and dispersion (standard deviation, range) for continuous variables, as well as frequencies and percentages for categorical variables. Statistical tests such as a t-test and chi-square test will be employed for continuous and categorical variables within two groups. The principal analysis will compare the fluid intake volume between the intervention and control groups using the t-test. Secondary outcomes such as The Wisconsin Stone Quality of Life Questionnaire (WISQOL), Patient Health Questionnaire-9 Items (PHQ-9), International Physical Activity Questionnaire (IPAQ-SF ) and The Electronic Health Literacy Scale (eHEALS) will use repeated measures of Analysis of Variance (ANOVA) since they are measured over time and between two groups. If necessary, subgroup analyses will be conducted to explore whether the effect of the intervention varies across different demographic or clinical subgroups. Intention-to-treat (ITT) analysis will be used to assess the impact of the treatment and its generalizability. A significance level of p \< 0.05 will be utilized to determine statistical significance, and all data analysis procedures will be conducted using the SPSS (Statistical Product and Service Solutions) 26.0 software package.The researcher is granted access to the complete trial dataset, with a contractual agreement established with the statistician to manage the data confidentially in accordance with the research protocol.
94 studies on the registry are indexed under Urinary Calculi; 20 are open to participants now.
This study's planned enrollment of 148 is above the median of 120 across 61 interventional studies indexed under Urinary Calculi.
Browse Urinary Calculi studies →The University of Hong Kong is the lead sponsor of 1,292 studies on the registry; 348 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard care or usual care such as receiving standard dietary and verbal education counselling will be delivered in this arm
Other: Standard care
WeChat Applet intervention involving both standard care and WeChat applet will be delivered to the experimental arm
Other: Experimental
Receiving standard dietary and regular recommendations such as education profile and counseling to achieve a fluid intake ≥ 2500 ml, providing verbal health education counseling regarding urological calculi prevention during the hospitalization, and adequate fluid intake in person on the day of discharge. Prepare a fixed-capacity water bottle. Phone calls will be given at each follow-up phase to collect primary and secondary data via the questionnaires.
Receive the same standard dietary counseling and education handout but also the WeChat applet intervention. A WeChat-based applet will be developed for fluid intake adherence improvement and self-monitoring to prevent urinary calculi, including fluid intake reminders, fluid value recording, urine value and coluor recording, and health education, an interactive platform for communication among post-operative patients with urinary stones. The applet will tailor the daily notification to participants of fluid intake to increase their fluid consumption to more than 2,500 ml. Extra education information regarding the benefits of adherence will be provided to the experimental group only via the applet. Phone calls will be given at each follow-up phase to collect primary and secondary data via the questionnaires.
24-hour urine volume (ml)
24-hour urine volume (ml) ： Measurement method: Participants will void into a calibrated container upon waking in the morning and record the precise start time (e.g., 8:00 AM). At the same time point 24 hours later, urine volume will be remeasured. Cumulative urine output will be tracked using a WeChat-based applet or alternative recording tools.
Time frame: Up to three months
24-hour fluid intake volume (ml)
24-hour fluid intake volume (ml) ： Measurement method: Participants will record all fluid consumption (including water, tea, coffee, herbal tea, and other eligible liquids) over a standardized 24-hour period using a WeChat-based applet. Recording will begin and end at the same time daily.
Time frame: Up to three months
Wisconsin Stone Quality of Life Questionnaire (WISQOL)
Scale range: A 5-point scale from 1 to 5 yielding a total score range between 28 and 140 points, a higher score indicates a better quality of life
Time frame: Up to three months
Patient Health Questionnaire-9 items (PHQ-9)
9 items with a cumulative score on the PHQ-9 range from 0 to 27 points, the higher score represented a greater severity of depressive symptoms;
Time frame: Up to three months
International Physical Activity Questionnaire-Short Form (IPAQ-SF)
score Calculation: Metabolic Equivalent of Task (MET) = MET value (3.3-8) × activity duration (minutes) × frequency (days) Classification: \<600 MET-min/week = low activity; 600-3000 MET-min/week = middle activity; \>3000 MET-min/week = high activity
Time frame: [Time Frame: Up to three months]
eHealth Literacy Scale (eHEALS)
A scale including 8 items with a five-point Likert scale; Scale range: 8-40 points (higher scores indicate better eHealth literacy)
Time frame: Up to three months
Number of outpatient visits or readmission
The number of outpatient visits is defined as the frequency of medical consultations during the study period due to urinary calculi-related symptoms (e.g., hematuria, pain) or complications (e.g., urinary tract infections). Readmission is defined as hospitalization events resulting from stone recurrence, severe complications, or surgical requirements.
Time frame: Up to three months
Plan to share: Yes — Datas collect from Primary outcome such as 24-hour urine volume (ml);24-hour fluid intake volume (ml) and secondary outcome such as The Wisconsin Stone Quality of Life Questionnaire (WISQOL);PHQ-9 (patient health questionnaire-9 items);IPAQ-SF (International Physical Activity Questionnaire);The eHEALS (Electronic Health Literacy Scale);The number of outpatient visits; recurrence rate will be shared. Part of the demographic data such as the time of using WeChat, gender, age, the type of surgery and BMI will shared.
Supporting information: Informed consent form
Time frame: The data will be available for 3 years: The start date: 1 Dec 2025; The end date: 30 Nov 2028.
Access criteria: IPD and supporting information collected in this study will be accessible exclusively to accredited researchers. These researchers must be members of academic institutions or research organizations relevant to the field of this study and possess a clear research purpose along with a rational analysis plan. Additionally, researchers are required to sign a data use agreement to ensure the confidentiality and compliant use of the data. Content Available for Access: Researchers will have access to de-identified IPD, encompassing participants' baseline characteristics, interventions, follow-up data, and primary and secondary outcome measures. Supporting information, such as the study protocol and statistical analysis plan, will also be provided to aid researchers in understanding the data structure and analysis methods. Mechanism of Access: Data access will be facilitated through a secure online data-sharing platform. Researchers are required to register and submit data access application.
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