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Urinary CalculiNCT06990672

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

A study testing Experimental in people with Urinary Calculi and Postoperative Care, run by The University of Hong Kong at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Experimental
Could I receive a placebo?
No, everyone receives an active treatment
How many people
148 participants
Where
1 siteChina
Study dates
1 Mar 2025to 31 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • Shenzhen Qianhai Shekou Free Trade Zone Hospital

    Shenzhen, Guangdong, 51800

Other trials in China

About this study

Official title: Developing and Evaluating a WeChat-based Digital Therapeutic Intervention To Enhance Postoperative Fluid Adherence In Patients With Urinary Calculi: Study Protocol

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
Read the 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.

Being tested
Standard care, Experimental
Keywords
Fluid Adherence, Urinary Calculi, Digital Therapeutic, WeChat Applet, Post-operative
Medical subject headings
Urinary Calculi

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard careOther

    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.

  • ExperimentalOther

    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.

Study groups in NCT06990672
Study groupRoleWhat they receive
Standard careOtherStandard care or usual care such as receiving standard dietary and verbal education counselling will be delivered in this arm
Receives: Other: Standard care
WeChat Applet InterventionExperimentalWeChat Applet intervention involving both standard care and WeChat applet will be delivered to the experimental arm
Receives: Other: Experimental

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to three months

  2. 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.

    Measured: Up to three months

Secondary outcomes (5)

  1. 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

    Measured: Up to three months

  2. 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;

    Measured: Up to three months

  3. 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

    Measured: [Time Frame: Up to three months]

  4. 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)

    Measured: Up to three months

  5. 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.

    Measured: Up to three months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2025
  2. Study start1 Mar 2025
  3. Primary completion1 Oct 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
148 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06990672
Sponsor's protocol ID
UW24-754
Status last verified
May 2025
First submitted
3 May 2025
Last updated
25 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • 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.

  • Zhou X, Wang T, Chen Q. Developing and Evaluating a WeChat-Based Applet Fluid Intake Reminder on Enhancing Fluid Adherence in Postoperative Patients With Urinary Calculi: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 Feb 19;15:e80214. doi: 10.2196/80214.

    PubMed 41712953

Questions about this trial

What is this clinical trial studying?

A study testing Experimental in people with Urinary Calculi and Postoperative Care, run by The University of Hong Kong at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

24-hour urine volume (ml) (time frame: Up to three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06990672, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.

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