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Enrolling by Invitation

NCT Number: NCT06990672

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

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Key information

Conditions

Urinary Calculi Calculi Chronic Disease Prevention Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Care Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shenzhen Qianhai Shekou Free Trade Zone Hospital

Shenzhen, Guangdong, 51800, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 24-hour urine volume (ml)

    Time frame: Up to three months

    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.

  2. 24-hour fluid intake volume (ml)

    Time frame: Up to three months

    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.

Secondary outcomes

  1. Wisconsin Stone Quality of Life Questionnaire (WISQOL)

    Time frame: Up to three months

    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

  2. Patient Health Questionnaire-9 items (PHQ-9)

    Time frame: Up to three months

    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;

  3. International Physical Activity Questionnaire-Short Form (IPAQ-SF)

    Time frame: [Time Frame: Up to three months]

    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

  4. eHealth Literacy Scale (eHEALS)

    Time frame: Up to three months

    A scale including 8 items with a five-point Likert scale; Scale range: 8-40 points (higher scores indicate better eHealth literacy)

  5. Number of outpatient visits or readmission

    Time frame: Up to three months

    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.

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Shenzhen Nanshan District Shekou People's Hospital

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 25, 2025
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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