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

Overview

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

• Other Standard 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.
• Other Experimental
  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 participan

Primary outcome measures

• 24-hour urine volume (ml) [Time frame: Up to three months]
• 24-hour fluid intake volume (ml) [Time frame: Up to three months]

Secondary outcome measures (5)

• Wisconsin Stone Quality of Life Questionnaire (WISQOL) [Time frame: Up to three months]
• Patient Health Questionnaire-9 items (PHQ-9) [Time frame: Up to three months]
• International Physical Activity Questionnaire-Short Form (IPAQ-SF) [Time frame: [Time Frame: Up to three months]]
• eHealth Literacy Scale (eHEALS) [Time frame: Up to three months]
• Number of outpatient visits or readmission [Time frame: Up to three months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

China · 1 center

• Shenzhen Qianhai Shekou Free Trade Zone Hospital — Shenzhen

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 urol

Identifiers

NCT: NCT06990672 · UW24-754

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗