Clinical trial NCT06990672: WeChat-Based Digital Therapy to Improve Fluid Intake in Kidney Stone Patients: Study Protocol
Official title: Developing and Evaluating a WeChat-based Digital Therapeutic Intervention To Enhance Postoperative Fluid Adherence In Patients With Urinary Calculi: Study Protocol
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Urinary Calculi
Postoperative Care
Chronic Disease Prevention
Keywords: Fluid Adherence
Urinary Calculi
Digital Therapeutic
WeChat Applet
Post-operative
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Shenzhen Qianhai Shekou Free Trade Zone Hospital
First posted: 2025-05-25
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 color recording, health education, an interactive platform for urinary stone prevention among post-operative patients with urinary stones. The WeChat applet will tailor the daily notification to participants of fluid intake to increase their daily 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.
Primary purpose: PREVENTION

Brief summary: 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:

1. Using the WeChat-based applet or a placebo every day for 3 months
2. Keep a record of their fluid intake, urine output, number of urinary calculi recurrence

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* With a history of urinary calculi and having received urolithiasis surgery before
* 24-hour fluid intake \< 2500 ml
* Age ≥ 18 years old
* Able to use WeChat daily
* Able to read and write informed consent

Exclusion Criteria:

* Participants with obstructive uropathy, chronic urosepsis, renal failure, and renal tubular acidosis
* Participants with congestive heart failure, psychiatric conditions, pregnancy, and primary hyperparathyroidism
* Participants experienced complicated urolithiasis surgery.
* History of recurrent UTI (urinary tract infection) (\>3/year)
* Medication use increases stone risk.
* Participants with physical disabilities

Primary outcomes:
measure: 24-hour urine volume (ml)
timeFrame: Up to three months
measure: 24-hour fluid intake volume (ml)
timeFrame: Up to three months
Secondary outcomes:
measure: Wisconsin Stone Quality of Life Questionnaire (WISQOL)
timeFrame: Up to three months
measure: Patient Health Questionnaire-9 items (PHQ-9)
timeFrame: Up to three months
measure: International Physical Activity Questionnaire-Short Form (IPAQ-SF)
timeFrame: [Time Frame: Up to three months]
measure: eHealth Literacy Scale (eHEALS)
timeFrame: Up to three months
measure: Number of outpatient visits or readmission
timeFrame: Up to three months
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Qianhai Shekou Free Trade Zone Hospital
state: Guangdong
Study officials:
References:
citation: 1. Shafi, H., et al., An overview of treatment options for urinary stones. Caspian journal of internal medicine, 2016. 7(1): p. 1. 2. Sorokin, I., et al., Epidemiology of stone disease across the world. World journal of urology, 2017. 35: p. 1301-1320. 3. Romero, V., H. Akpinar, and D.G. Assimos, Kidney stones: a global picture of prevalence, incidence, and associated risk factors. Reviews in urology, 2010. 12(2-3): p. e86. 4. Zeng, G., et al., Prevalence of kidney stones in China: an ultrasonography based cross-sectional study. BJU international, 2017. 120(1): p. 109-116. 5. Johnson, C.M., et al., Renal stone epidemiology: a 25-year study in Rochester, Minnesota. Kidney international, 1979. 16(5): p. 624-631. 6. Pearle, M.S., et al., Urologic diseases in America project: urolithiasis. The Journal of urology, 2005. 173(3): p. 848-857. 7. Moftakhar, L., et al., Prevalence and risk factors of kidney stone disease in population aged 40-70 years old in Kharameh cohort study: a cross-sectional population-based study in southern Iran. BMC urology, 2022. 22(1): p. 205. 8. Fakheri, R.J. and D.S. Goldfarb, Ambient temperature as a contributor to kidney stone formation: implications of global warming. Kidney international, 2011. 79(11): p. 1178-1185. 9. Becerra, A.Z., et al., Contemporary assessment of the economic burden of upper urinary tract stone disease in the United States: analysis of one-year health care costs, 2011-2018. Journal of Endourology, 2022. 36(4): p. 429-438. 10. Lotan, Y., et al., Primary prevention of nephrolithiasis is cost-effective for a national healthcare system. BJU international, 2012. 110(11c): p. E1060-E1067. 11. Mitra, P., D.K. Pal, and M. Das, Does quality of drinking water matter in kidney stone disease: A study in West Bengal, India. Investig Clin Urol, 2018. 59(3): p. 158-165. 12. Mathiyalagen, P., et al., A case-control study on environmental and biological risk factors for renal calculi persisting in a coastal Union Territory, India.