WeChat-Based Digital Therapy to Improve Fluid Intake in Kidney Stone Patients: Study Protocol

NCT06990672 | Enrolling By Invitation

• 1 other identifier: UW24-754
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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

Conditions

Urinary Calculi; Postoperative Care; Chronic Disease Prevention

Keywords

Fluid Adherence; Urinary Calculi; Digital Therapeutic; WeChat Applet; Post-operative

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to three months

Secondary Outcomes (5)

• Wisconsin Stone Quality of Life Questionnaire (WISQOL)

  Up to three months

• Patient Health Questionnaire-9 items (PHQ-9)

  Up to three months

• International Physical Activity Questionnaire-Short Form (IPAQ-SF)

  [Time Frame: Up to three months]

• eHealth Literacy Scale (eHEALS)

  Up to three months

• Number of outpatient visits or readmission

  Up to three months

Study Arms (2)

Standard care

OTHER

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

EXPERIMENTAL

WeChat Applet intervention involving both standard care and WeChat applet will be delivered to the experimental arm

Other: Experimental

Interventions

Standard care OTHER

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.

Standard care

Experimental OTHER

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.

WeChat Applet Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female and Male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead
• Shenzhen Qianhai Shekou Free Trade Zone Hospital: collaborator

Study Sites (1)

Shenzhen Qianhai Shekou Free Trade Zone Hospital

Shenzhen, Guangdong, 51800, China

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Urinary Calculi

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Urolithiasis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: To ensure the integrity and objectivity of outcome assessments in this randomized controlled trial, independent outcomes assessors, who are masked to participants' group assignments, will be employed. These assessors, comprising trained research nurses and clinical research coordinators not involved in the delivery of the WeChat applet intervention or usual care, will be responsible for evaluating primary and secondary outcomes. Masking will be maintained through secure data management systems that conceal group allocation (WeChat applet vs. usual care) during data collection and analysis. The assessors will receive training on standardized outcome measurement protocols and will have no direct interaction with participants or intervention staff to prevent unmasking. This approach minimizes assessment bias, enhancing the reliability of trial results.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DN Candidate

Model Details: 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.

Study Record Dates

• First Submitted: May 3, 2025
• First Posted: May 25, 2025
• Study Start: March 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: December 31, 2025
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• 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.

Locations

CN (1)