The global incidence of urinary calculi has been on an upward trajectory
[1]. China is one of the 3 countries with the heaviest burden of urinary calculi worldwide
[2], imposing substantial economic consequences on both individuals and society
[3-5]. Moreover, urinary calculi has an estimated 5-year recurrence rate of up to 50%
[6]. Although many stones are asymptomatic for long periods of time, once they recur, the events of pain, infection, or obstruction caused by the stones can have a significant impact on the patient’s quality of life
[7-8]. Implementing long-term, continuous, and timely monitoring of therapeutic efficacy, systematic symptom evaluation, and close follow-up serves as a critical clinical strategy for mitigating urinary calculi recurrence risks and optimizing patient quality of life. However, there are several challenges in the follow-up management of patients with urinary calculi, including fixed content, single form, delayed doctor-patient communication, and lack of personalization
[9-10]. It cannot meet the needs of whole-course management. Therefore, especially for patients characterized by chronic urinary calculi and multiple recurrences, establishing a highly efficient and intelligent follow-up platform can provide comprehensive management support post-discharge and ensure receipt of timely and effective follow-up services. The European Urology Association (EUA) proposed that telemedicine provide specialized clinical support for urologists at a distance via technological tools
[11]. Incorporating innovative telemedicine strategies into follow-up management paths is one way to meet the needs of improving the health and care of patients with urinary calculi. This study aims to develop an intelligent follow-up platform based on WeChat to construct a tripartite collaborative model of remote follow-up program for patients with urinary calculi [hereinafter referred to as remote collaborative follow-up (RC-follow-up)], in order to provide multi-dimensional personalized follow-up management approaches for this patient population.
1 Subject and methods
1.1 Ethical statement
This study was approved by the Ethics Committee of the Third Xiangya Hospital of Central South University (R24042) and was registered with the Chinese Clinical Trial Registry (ChiCTR2400087736).
1.2 Participants
The study adopted a single-blind, two-group, randomized controlled trial design with a repeated-measure design to examine the effects of an RC-follow-up program amongst urinary calculi patients. The participants were recruited from the ward of urology department of a tertiary hospital in Changsha, China, between August and November 2024. The inclusion criteria were as follows: 1) Age ≥18 years; 2) had undergone minimally invasive urinary calculi surgery during this hospitalization; 3) had a smartphone on which they could access the internet and a smartphone application; 4) were able to understand Mandarin and provide informed consent to participate in the study; and 5) were willing to provide their contact number. The exclusion criteria included patients with neoplasms, severe renal insufficiency, or an uncontrolled infection.
1.3 Methods
1.3.1 Sample size estimation
The sample size was determined through power analysis by using PASS software version 15. A two-mean test randomized control design was adopted with a significance level of 0.05. The primary indicator, health-related quality of life (HRQOL), was used to calculate the sample size. According to a previous relevant study
[12], with σ=12 and δ=8.5, a total of 82 participants (42 per group) were required to detect a significant difference between the 2 groups at a 5% significance level and a power of 0.8. To account for a potential dropout rate of 20%, the final sample size was set at 106 participants (53 per group) at least.
1.3.2 Randomization, concealment, and blinding
The randomization sequence was generated with an online randomization program by a research assistant who was not involved in the study. A labeled card indicating the random group allocation (1 was 1-month RC-follow-up; 2 was 1-month routine follow-up) was placed into sequentially numbered, opaque, sealed envelopes by the research assistant. The order in which each participant entered the study was based on discharge time. The study was single-blinded, and the research assistants who were responsible for data collection and statistical analysis were blinded to the group assignments.
1.3.3 Intervention
In this study, a follow-up system with remote collaborative management was developed based on the WeChat Mini Program, consisting of 3 interfaces: A management terminal, a health care team terminal (web-based), and a patient terminal (Mini Program). 1) Management Terminal: Managed by computer professionals in the research team, this terminal was responsible for unified allocation of user accounts, ensuring the security of patient information, monitoring follow-up activities and data, publishing health education resources, and maintaining/upgrading the follow-up platform. 2) Health care team: Nurses used this interface to input patient information. Through analyzing clinical data, communicating with patients, and assessing recurrence risk factors, they developed individualized follow-up plans and entered them into the system. 3) Patient terminal: Patients accessed the Mini Program to view follow-up content and health education materials, and used the online consultation platform to communicate with nurses.
Through these 3 terminals, the system can dynamically identify low-compliance behaviors during follow-up, statistically summarize follow-up data, and determine patients’ dynamic needs. This enabled the follow-up team to provide targeted health education and better meet patients’ follow-up requirements. The framework of follow-up program is shown in
Figure 1.
1.3.3.1 Intervention group
A collaborative, multidisciplinary urinary calculi follow-up program was established at our single medical institution in May 2023. A health care team was developed consisting of urology specialists to conduct the postoperative evaluation and develop follow-up programs; dietary specialists to oversee the metabolic, dietary, and preventive management of stone disease; and nurses responsible for making follow-up appointments or new referrals to the patient.
Participants randomized to the intervention group were invited to subscribe to the WeChat Mini Program on their smartphone post-baseline survey completion. This account comprised 4 components: Health knowledge, follow-up plans, online consultation, and personal centers. The online consultation function was designed to facilitate health counseling of participants during the follow-up period, and they could use text or pictures to contact the researchers. The WeChat Mini Program logins required specific and unique accounts and passwords provided by the research assistant, and only participants in the intervention group were allowed to subscribe, which mitigated confounding factors.
The RC-follow-up program was developed following a literature review and Delphi consultation. Potential participants were identified by the urology specialists, after which the supervisor nurse conducted a brief interview with the patient. The main purpose of the interview was to understand the lifestyle habits of the participants and guide the subsequent lifestyle follow-up. The researchers integrated patient diagnosis and treatment information, which was accessed from the Hospital Information System, with interview information, to formulate follow-up programs. The research assistant established a follow-up file for each participant and recorded the corresponding follow-up programs in the management system, which would regularly send the follow-up items to the specific participant in the follow-up plan in the WeChat Mini Program according to the follow-up frequency. The flow of RC-follow-up program is shown in
Figure 2.
1.3.3.2 Control group
Participants in the control group received routine follow-up and services per the unit, including routine health education, discharge guidance, and a follow-up call at 1-month post-discharge.
1.3.4 Data collection and outcomes
The indicators used in our study were divided into 3 categories: Health-related indicators of participants, clinical evaluation indicators of participants, and satisfaction. The primary outcome was health-related indicators of the participants, including HRQOL and health-promoting lifestyle (HPL). The secondary outcomes were clinical measures of forgotten ureteral stent (FUS), ureteral stent-related complications, and unplanned readmission. Satisfaction was another secondary indicator. Primary outcomes were collected 15 days after discharge (T1) and 30 days after discharge (T2). Secondary outcome measures were collected only at T2. Two data collectors (blinded to group assignments) scheduled face-to-face assessment appointments for participants to collect baseline data before discharge (T0). Similarly, they completed questionnaires at each time point where data were collected via Wenjuanxing and telephone.
1.3.4.1 Demographic questionnaire
All participants’ demographic data and clinical traits were gathered via a self-designed questionnaire. The patients’ demographic information included their age, sex, body mass index, marital status, residence, hospitalization insurance, smoking status, drinking status, stone site, and surgical method.
1.3.4.2 Health-related indicators of participants
HRQOL was measured via the Chinese version of the WISQOL
[13]. The source scale was developed and validated by Penniston
[14]. The questionnaire consists of 28 questions, including 4 domains: Social impact, emotional impact, disease impact, and vitality impact (total score ranging from 28 to 140). Higher scores indicate better HRQOL for the patient. The Cronbach’s α of each dimension of this scale ranged from 0.64 to 0.94, and the total Cronbach’s α was 0.95.
HPL through self-care were measured via the Health Promotion Lifestyle Profile II (HPLP-II). The source scale was proposed by Walker in 1987
[15]. This study adopted the Chinese version of the Health Promotion Lifestyle Scale revised
[16]. The scale includes 6 dimensions: Interpersonal relationships, health responsibility, spiritual growth, sports, stress management, and nutrition (with a total of 40 items). The items were each rated on a 1 to 4-point scale (total score ranging from 40 to 160). The Cronbach’s α of the scale ranged from 0.63 to 0.81, and the test-retest reliability for HPLP-II was 0.69.
1.3.4.3 Clinical evaluation indicators of participants
FUS: The number of patients whose ureteral stents were not replaced or removed in time according to discharge advice.
Rate of ureteral stent-related complications: Complications included bladder irritation, hematuria, pain, and stent displacement.
30-Day rate of unplanned readmission: Unplanned readmission refers to readmission in patients with the same or related conditions within 30 days after discharge (except for secondary surgery).
1.3.4.4 Satisfaction
The Client Satisfaction Questionnaire (CSQ-8) was used to assess participant satisfaction at T2. CSQ-8 was developed by Larsen
[17] to evaluate patients’ satisfaction with medical service. It consists of 8 items, using a 4-point Likert scale and the total score is 32 points. The Cronbach’s α of this scale was 0.93.
1.4 Statistical analysis
The data were analyzed via SPSS 21.0 (IBM SPSS Data Collection, New York, USA). Measurement data were expressed as means±standard deviations. Counting data were expressed as frequencies (percentages). Independent t-tests, Mann-Whitney U tests, Chi-square tests, or Fisher’s exact tests, as applicable, were utilized to compare the demographic and clinical traits of the individuals in the 2 groups.
This study followed the Intention-To-Treat (ITT) principle, and all randomized participants were included in the final analysis according to their initial assigned groups. Comparison of HRQOL and HPL scores between the 2 groups of patients at baseline (T0), T1, and T2 was performed. For data that were normally distributed and exhibited homogeneity of variances, repeated-measures analysis of variance (RM-ANOVA) was employed. Mauchly’s test of sphericity was conducted; if the assumption of sphericity was met, the RM-ANOVA results were interpreted to assess the main effects of the group, time, and interaction between the 2 groups. If the data violated the assumptions of normality and/or homogeneity of variances, or if missing data were present in the study, generalized estimating equation (GEE) analysis was used. This study used a bilateral test, with a difference of P<0.05 being statistically significant.
2 Results
2.1 Characteristics of participants
In the screening of 209 participants, 91 participants were excluded. A total of 118 eligible participants agreed to participate in this study and were randomly assigned to the intervention group (
n=59) or the control group (
n=59). In the intervention group, 57 (96.61%) completed the entire follow-up. In the control group, 54 (91.53%) completed the entire follow-up, with discontinuing participation for reasons including loss of contact (
n=2) and refusal to complete the questionnaire (
n=3).
Figure 3 shows the CONSORT flow diagram of the recruiting process as well as the specific reasons individuals dropped out. All 118 participants were included in the GEE analysis. There were no statistically significant differences in demographics between the excluded participants and those included in the analysis.
The participants were (49.3±11.58) years old (ranging from 22 to 71 years), with more than half of the patients being male (64/118), and the majority of the participants were married (110/118). Out of 118 participants, 53 (44.9%) lived in the city, and 51 (43.2%) were employed full-time. The majority of participants were insured in the basic medical insurance (75/118). Sixteen (13.6%) out of 118 participants reported current cigarette use, and 10 (8.5%) out of 118 participants reported current alcohol consumption. At T0, baseline comparisons revealed no statistically significant differences between the 2 groups in terms of age, gender, BMI, marital status, residence, hospitalization insurance, smoking status, drinking status, stone site, and surgical method (all
P>0.05,
Table 1).
2.2 Follow-up results
2.2.1 Comparison of health-related indicators of participants
The HRQOL score at T0 were (105.36±12.06) and (106.24±8.37) in the intervention and control groups, respectively, with no statistically significant difference (
P=0.646). The GEE results revealed that there was a significant between-group difference at T1 and T2 (
P<0.001). HRQOL showed a discernible change over time (Wald’s
χ2=23.065,
P<0.001). Moreover, the group-by-time interaction was significant (
P<0.05). For HPL, there was a significant between-group difference (
P<0.001), which improved at all time points (
P<0.05). The group-by-time interaction was significant (
P<0.001, Table
2 and
3).
2.2.2 Comparison of clinical evaluation indicators of participants
There were no significant differences in the incidence of FUS, ureteral stent-related complications, or unplanned readmission at T2 between the 2 groups (all
P>0.05,
Table 4).
2.2.3 Comparison of patient’s satisfaction
Compared with the control group, the intervention group had greater overall satisfaction at T2 [(28.91±2.64) vs (26.70±3.04), t=4.089，P<0.001].
3 Discussion
In this randomized controlled clinical trial, we presented compelling evidence for the implementation of post-discharge follow-up protocols for patients with urinary calculi. Our innovative approach encompassed 3 key components: 1) A comprehensive nursing interview focused on pertinent discharge follow-up inquiries. 2) Utilization of the WeChat Mini Program, a patient-centric tool for home-based monitoring. 3) An automated follow-up system that provided regular summaries and timely feedback. Through these pioneering strategies, we offered an accessible and comprehensible approach that empowered participants to increase their disease awareness and foster healthy lifestyles.
HRQOL reflects the health status of individuals or populations from physical, psychological, and social dimensions, serving as a critical indicator for evaluating patient health. Currently, global nursing standards and management guidelines for urinary calculi primarily focus on achieving a “stone-free” state in patients, often overlooking their quality of life. A literature review
[18] noted that HRQOL in patients with urinary stones is clinically significantly reduced in domains such as general health, physical pain, physical function, and vitality. This study showed that implementing the RC-follow-up program led to significantly better HRQOL in the intervention group compared with routine follow-up. This difference may be attributed to the synergistic effect of the follow-up system’s real-time reminder function and personalized interventions. Early research
[19] has demonstrated that standardized regular reminders can reduce postoperative complications in patients with indwelling double-J stents and improve quality of life. The dynamic reminder function of the RC-follow-up management system addresses this gap. Additionally, the intelligent follow-up system clarifies patients’ self-management goals and reinforces their disease knowledge, thereby enhancing patient self-efficacy and improving HRQOL to a certain extent
[20].
Lifestyle plays a significant role in the increasing prevalence of urinary calculi
[21]. This study found that both groups of patients scored approximately 97 on the HELP-II Scale at T0, which suggests that this population may commonly lack knowledge about healthy lifestyles. The result of GEE demonstrated that implementing the RC-follow-up program significantly promoted the adoption of health-promoting lifestyles among urinary calculi patients, with this reinforcing effect becoming more pronounced over time (
P<0.05). The formation of urinary calculi is closely linked to unhealthy lifestyles, with postoperative lack of physical activity, inadequate hydration, and improper diet being major risk factors for recurrence
[22-23]. A scoping review highlighted that various information and communication technologies (ICTs), such as websites, short message service, and mobile applications, can effectively facilitate health behaviors
[24]. In our study, we utilized WeChat to establish a follow-up system, assisting patients to develop a healthy lifestyle.
This study found that the RC-follow-up program failed to reduce clinically relevant outcomes post-discharge. No significant differences were observed between the 2 groups in incidence of FUS, ureteral stent-related complication, or unplanned readmission. Previous study
[25] has indicated that patient-related factors account for over 80% of FUS, primarily due to poor compliance, impaired recall, and lack of awareness regarding the necessity of timely removal. The second most common cause involves inadequate counseling by healthcare providers. Notably, no cases of delayed or FUS removal occurred during our follow-up period. This may be attributed to the essential reminder functions served by both routine follow-up procedures and the implemented RC-follow-up program. Additionally, there was no significant difference in unplanned readmission rates between the 2 groups, potentially due to the relatively short follow-up duration and limited sample size, which may have hindered our ability to detect differences in incidence of FUS and readmission.
Participants expressed high satisfaction with the RC-follow-up program, with the majority reporting significantly higher satisfaction in areas such as received follow-up services, expected outcomes, and timely problem-solving. This may primarily be attributed to the timeliness of information and the expanded consultation channels provided by the follow-up system. The follow-up system provided multidimensional, targeted support that fundamentally transformed patient engagement. Crucially, it transcended the spatiotemporal constraints inherent in routine follow-up, enabling patients to access personalized rehabilitation guidance anytime and anywhere and fostering closer communication with healthcare providers.
Our study has several limitations. First, selection bias may limit the generalizability of our findings, as participants were recruited from a single medical center. Second, the short follow-up period of this study allowed us to assess only the short-term effects of the intervention; the long-term effects remain unknown and require further investigation in a trial with a longer follow-up duration. Third, patients’ ability to use the WeChat Mini Program may have limited access to health education information and online consultation for some elderly participants, potentially affecting follow-up outcomes.
In conclusion, the study demonstrated that an intelligent medical collaboration model-based remote follow-up program can significantly improve the quality of life and health-promoting behaviors of patients with urinary calculi. However, at the 1-month follow-up, this intervention did not immediately impact FUS, ureteral stent-related complications, or unplanned readmission. To fully evaluate these aspects, further studies with longer follow-up periods may be warranted.
the Innovation Platform’s Open Foundation of Education Department of Hunan Province(18K004)
the Natural Science Foundation of Hunan Province(2025JJ50508)
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