Chronic Disease Prevention, Postoperative Care, Urinary Calculi
Conditions
Keywords
Fluid Adherence, Urinary Calculi, Digital Therapeutic, WeChat Applet, Post-operative
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.
Interventions
OTHERStandard care
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.
OTHERExperimental
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.
Sponsors
Shenzhen Qianhai Shekou Free Trade Zone Hospital
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24-hour urine volume (ml) | 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. |
| 24-hour fluid intake volume (ml) | 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
| Measure | Time frame | Description |
|---|---|---|
| International Physical Activity Questionnaire-Short Form (IPAQ-SF) | [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 |
| Wisconsin Stone Quality of Life Questionnaire (WISQOL) | 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 |
| Number of outpatient visits or readmission | 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. |
| eHealth Literacy Scale (eHEALS) | 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) |
| Patient Health Questionnaire-9 items (PHQ-9) | 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; |
Countries
China
Outcome results
None listed