Impact of Mobile Application and Outpatient Follow-up on Renal Endpoints and Physiological Indices in Patients with Chronic Kidney Disease: A Retrospective Cohort Study in Southwest China

doi:10.21203/rs.3.rs-3233251/v1

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Research Article

Impact of Mobile Application and Outpatient Follow-up on Renal Endpoints and Physiological Indices in Patients with Chronic Kidney Disease: A Retrospective Cohort Study in Southwest China

https://doi.org/10.21203/rs.3.rs-3233251/v1

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published 12 Jun, 2024

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Background

Chronic kidney disease (CKD) is a significant public health concern, and patient self-management is an effective approach to manage the condition. However, there is little evidence on the effectiveness of mobile app for self-management interventions among Chinese CKD patients. This study aimed to investigate whether using a mobile application combined with traditional outpatient follow-up can improve health outcomes of CKD patients.

Methods

This retrospective cohort study recruited CKD patients with stage 1–5 who were not receiving renal replacement therapy from a CKD management center. Two groups were established: the APP + outpatient follow-up group and the traditional outpatient follow-up group. Baseline data was collected from January 2015 to December 2019, followed by a three-year long-term follow-up until December 2022. Laboratory data, all-cause mortality, and renal replacement treatment were then collected and compared between the two groups.

Results

5326 patients were included in the study, including 2492 in the APP + outpatient group and 2834 in the traditional outpatient group. After IPTW virtualization matching, the final matched the APP + outpatient group consisted of 2489 cases (IQR, 33–55) and 2850 (IQR, 33–55) in the traditional outpatient group. By the end of the study, it was observed that the laboratory data of Phosphorus, Sodium, Triglyceride, Hemoglobin showed significant improvements, Furthermore the APP + outpatient group demonstrated superior results compared to the traditional outpatient group (P < .05). And it was observed that there were 34 deaths (1.4%) in the APP + outpatient group and 46 deaths (1.6%) in the traditional outpatient group(P = .49). After matching for renal replacement therapy outcomes, the two groups were found to be comparable (95% CI [0.72–1.08], P = .23), with no significant difference. However, it was noted that the traditional outpatient group had a lower incidence of using temporary catheters during initial hemodialysis (95% CI [8.4%-29.8%], P < .001).

Conclusion

The development and application of an app combined with outpatient follow-up management can improve patient health outcomes. However, to ensure optimal preparation for kidney replacement therapy, patients in CKD stages 4–5 may require more frequent traditional outpatient follow-ups, and further develop an information-based decision-making support tool for renal replacement therapy.

mobile app

chronic kidney disease

remote follow-up

outpatient follow-up

retrospective cohort study

Chronic Kidney Disease (CKD) is a prevalent and costly health condition worldwide. The prevalence of CKD is 10.8% in China and as high as 18.3% in the southwest regions[1]. As CKD progresses to end-stage renal disease, the incidence of complications and death increases, and complications of CKD include cardiovascular disease, anemia, bone and mineral disorders, and cognitive decline, all of which are associated with high healthcare costs[2, 3]. The KDIGO guidelines state that regular follow-up and standard management can effectively improve patient health outcomes, slow the rate of disease progression, and reduce the incidence of complications[4].

With the popularity of mobile phones, the development of mobile health management has become a central focus[5, 6]. The number of smartphone users in the world is on the rise and is projected to grow to 6.4 billion in 2021; 94% of people in developed countries own a smartphone, and more than 90% of people in China use mobile phones, which brings convenience to the new health management model. Smartphone apps are increasingly used to facilitate the self-management of patients with chronic diseases such as COPD[7], asthma[8], heart disease[9] and diabetes[5]. Studies have shown that smartphone apps can achieve the ideal effect of disease control, reduce complications, and improve treatment compliance and satisfactionin patients with CKD[10].

Based on the theory of patient self-management, we developed an APP called SuYi to facilitate long-term case management of CKD patients in conjunction with traditional outpatient follow-up. The current study aims to evaluate the impact of remote follow-up with a mobile application on patient outcomes, including laboratory data associated with renal function and incidence of renal endpoint events. Additionally, the study seeks to provide insights on the effectiveness of a hybrid approach to patient management that includes both traditional outpatient follow-up and remote follow-up with a mobile application. The results of this study can have significant implications for remote patient management and may inform the development of better strategies to manage CKD in a cost-effective and efficient manner.

Mobile App Development

The agile model is a widely known software development methodology used as a guiding framework for building and testing application prototypes. The model consists of four stages (conception, initiation and analysis, design and construction, testing and deployment) that describe the overall process of software development.

Conception Stage. Theoretical and empirical knowledge demonstrates that the self-management “process” is a major factor affecting adherence to chronic disease management, medical social resource utilization, and patient quality of life. Therefore, the core design, content and function of the Suyi App are key conceptual elements of self-management. Therefore, we formed a development team with doctors, nurses, engineers, and patients to create a list of tasks and procedures for the development of apps. The list was revised and grouped according to common CKD self-management goals in the clinical and research literature (Table 1), and operation systems such as IOS and Android wereselected for prototype development.

Initiation and Analysis Stage. ThinMed medical technology brings together a software development team (including engineers and designers) by four computer science practitioners, one algorithm engineer, one architect and one graphic designer developing the APP prototype. Continuously updated according to clinical needs and the next phase of application development and testing.

Design and Construction Stage. Based on the self-management process concept, the main objectives of the app design are 1) to simplify the patient‒physician communication process and 2) to assist patients in completing their home self-management more effectively. The design features of the app include the following: 1) scheduled follow-up appointments section; 2) task management push section; 3) practical knowledge push section; 4) automatic evaluation feedback section; 5) patient education live feature section; and 6) risk warning processing section. Figure 1 shows the screen diagram of the APP, and the outline of the process of the patient using the APP under the guidance of the health care provider.

Testing and Deployment Stage. A multidisciplinary CKD management team, development engineers and solution architects reviewed the app, asked questions, and then revised it again. Next, 10 patients (5 male and 5 female adults) were selected to complete the test using the app, following which they were asked for their opinions on improvements to the APP. Based on patient feedback, the font was enlarged, the sliding bar was changed to a numeric input keyboard, and occasional disconnections and flashbacks were resolved. Prior to the feasibility study, the APP was copyrighted (2020SR0835730). Additionally, approval from the institutional review board was obtained (2018-R006-01).

Table 1 Content of Suyi App

Study design

The study was a retrospective cohort study, the primary objective was to assess the effects of two follow-up methods (" APP + outpatient follow-up "and"traditional outpatient follow-up ") improves laboratory data associated with renal function, reduces all-cause mortality, reduces the occurrence of renal replacement(hemodialysis(HD) /peritoneal dialysis(PD) / renal transplant(RT)) or avoids the initiation of urgent dialysis(defined as use of temporary catheters when initial hemodialysis).

Setting

Patients enrolled in the CKD management center received long-term follow-up and management services from a dedicated nurse based on a case management model. The center was established in 2013, headed by one nurse director and one senior physician, and staffed with five full-time nurses. A kidney disease care clinic was in operation seven days a week (concurrently with a physician clinic), where all consultations were conducted by dedicated nurses. Case management included nutrition management, relevant diseases and complications management, medication management, symptom management, exercise management, and lifestyle management. The case management process consisted of assessment, planning, implementation, feedback, and evaluation. Patients were divided into two groups: the APP + outpatient follow-up group, where patients installed a mobile application and used it at least once a month, and had additional outpatient follow-ups at least once every three months; and the traditional outpatient follow-up group, where patients did not install the app and had outpatient follow-ups at least once every three months. All patients were followed up and managed according to the standard case management model (Fig. 1).

Participants

Patients who were enrolled in the CKD management center for long-term follow-up from January 2015 to December 2019 without receiving renal replacement therapy and with CKD stages 1–5 were included in this study. The inclusion criteria were as follows: 1) diagnosis of CKD stage 1 to 5 [GFR < 90 ml/(min 1.73 m²)], 2) age 18ཞ80 years old, and 3) no cognitive impairment, 4) with an outpatient follow-up at least once every 3 months. The exclusion criteria were as follows: 1) hemodialysis (HD), peritoneal dialysis (PD), or other treatment dialysis, renal transplantation (RT); 2) acute kidney injury; and 3) recent diagnosis of cancer,4) No outpatient follow-up was conducted for a period of more than 6 months. The collection of baseline data began in January 2020, and the study endpoint was December 2022. And refer to the flowchart below for specific screening process(Fig. 2).

Outcome measurement

Laboratory data. Laboratory data associated with renal function include: eGFR, Serum creatinine, Uric Acid, Calcium, Phosphorus, Kalium, Sodium (Na), Erythrocyte, Total Cholesterol, Triglyceride, Totol protein, Albumin, Parathormone, Hemoglobin.

All-cause mortality. Refers to the ratio of the number of deaths from all causes to the total number of patients in a certain period.

Incidence of entering renal replacement therapy. Refers to the ratio of the number of incidences of patients entering HD, PD, and RT to the total number of patients. The ratio of the number of incidences of patients entering HD, PD, and RT to those with CKD stage 4–5 at baseline was further analyzed.

The use rate of temporary dialysis catheter. The ratio between the number of patients using temporary catheters at the time of entry into HD and the total number of first-time HD patients. Reducing temporary dialysis catheter usage means avoiding the initiation of urgent dialysis.

Bias

In the retrospective analysis, Patients who failed to return for follow-up at the center, lost contact, or withdrew from follow-up were considered lost to follow-up (no longer receiving CKD outpatient follow-ups at least once every three months).Baseline data analysis was performed using inverse probability treatment weighting to ensure comparability of baseline characteristics.

Study size

Extracted through the in-hospital CKD management information system, eGFR < 90 ml/min/1.73 m² was selected by engineers entering computer language, and a total of 6015 patients who met the inclusion exclusion criteria were extracted. 2683 people in the APP + outpatient group and 3332 people in the traditional outpatient group. The occurrence of renal endpoint events in both groups was collected by HIS system extraction with telephone follow-up, and laboratory test indexes were automatically extracted by the system.

Statistical methods

The inverse probabilistic treatment weighting of the propensity score was used to balance the baseline health measures recorded in the comparison groups, including known indications for APP use[11, 12]. The propensity score was estimated by multivariable logistic regression with 164 covariates chosen a priori. Patients in the reference group were weighted. This method produces a weighted pseudo sample of patients in the reference group with the same distribution of measured covariates as the exposure group[13]. Standardized differences between unweighted and weighted samples were used to compare differences in baseline characteristics between groups (differences > 10% were considered meaningful). Weighted risk ratios and 95% CIs were obtained by modified Poisson regression, and weighted risk differences and 95% CIs were obtained by a binomial regression model with an identity link function. Two-tailed P values less than.05 were interpreted as statistically significant. Because multiple comparisons can lead to type I errors, the results of secondary, subgroup, and sensitivity analyses should be interpreted as exploratory analyses. Analyses were conducted using SAS statistical software, version 9.4 (SAS Institute Inc).

Study participants

From January 2015 to December 2019, 6015 of 8141 patients in the CKD management center met the selection criteria for inclusion in the study, they were divided into two groups according to whether they downloaded and usedthe APP(used it at least once a month), of whom 3332 people were enrolled in the CKD management center to receive APP + outpatient follow-up and 2683 patients were managed by traditional outpatient follow-up. During the follow-up period from January 2020 to December 2022, 191 patients were lost to follow-up in the APP + outpatient follow-up group, including 107 patients who chose to return for local follow-up, 73 patients who did not return for follow-up, and 11 patients who were lost to contact (unable to be reached by phone). In the traditional outpatient follow-up group, 498 patients were lost to follow-up, including 203 patients who chose to return for local follow-up, 276 patients who did not return for follow-up, and 19 patients who were lost to contact. At the end of the 36-month follow-up period, 2942 patients in the APP + outpatient follow-up group and 2834 patients in the traditional outpatient follow-up group were included in the analysis.(Fig. 2)

Descriptive data

The primary cohort consisted of 2492 patients (median, 45 years [IQR, 32–53]) in the APP + outpatient group and 2834 patients (median, 46 years [IQR, 34–56]) in the traditional outpatient group. After IPTW virtualization matching.(Fig. 3), the final matched APP + outpatient group consisted of 2489 cases (median, 46 years [IQR, 33–55]) and 2850 cases (median, 45 years [IQR, 33–55]) in the traditional outpatient group. Before weighting, all standardized differences were less than 10% except for age, EGFR1, PTH1, and Vit. D3, and after weighting, all standardized differences were less than 10%. (Table 2 )

Evaluation Outcomes

Laboratory data

The Wilcoxon signed-rank test indicates that the eGFR of patients in the APP + outpatient group increased after follow-up, while the eGFR of the traditional outpatient group decreased. Moreover, the Mann-Whitney test revealed differences in the increase of eGFR before and after follow-up between the two groups (P =.03). When compared to the traditional outpatient group, the APP + outpatient group showed significant improvements in laboratory data such as Phosphorus, Sodium, Triglyceride and Hemoglobin (P < .05). (Table 3 )

All-cause mortality outcomes

Before matching, there were 29 deaths (1.2%) in the APP + outpatient group and 49 deaths (1.7%) in the traditional outpatient group, with a rate difference of -0.57 (95% CI: -1.2 to 0.07) between the two groups, which was not significantly different (P = .09) (Table 4). After matching, there were 34 deaths (1.4%) in the APP + outpatient group and 46 deaths (1.6%) in the traditional outpatient group, with a rate difference of -0.26 (95% CI: -0.91 to 0.39), which was not significantly different (P = .49) (Table 4).

Renal replacement therapy outcomes

Renal replacement therapy consisted of hemodialysis, peritoneal dialysis, and renal transplantation. Before matching, overall replacement therapy had 211 cases (8.5%) in the APP + outpatient group and 210 cases (7.4%) in the traditional outpatient group, P = .15, which was not significant (Table 4). After matching, overall replacement therapy was available in 190 cases (1.4%) in the APP + outpatient group and 245 cases (8.6%) in the traditional outpatient group (P = .23), which was not significant (Table 4).

Temporary dialysis catheter outcomes

Before matching, a temporary dialysis catheter was performed in 60 cases (43.8%, [60/137]) in the APP + outpatient group and 31 cases (19.7%, [31/157]) in the traditional outpatient group, with a rate difference and 95% confidence interval of 24.1% [13.7%-34.4%], P < .001, and the rate of tube placement was significantly higher in the APP + outpatient group than in the traditional outpatient group (Table 5). After matching, a temporary dialysis catheter was placed in 54 patients in the APP + outpatient group (42.5%, [54/127]) and 40 patients in the traditional outpatient group (23.4%, [40/171]), with a rate difference and 95% confidence interval of 19.1% [8.4%-29.8%], P < .001, and the rate of tube placement in the APP + outpatient group was still significantly higher than that in the traditional outpatient group (Fig. 4).

This study aims to assess how the integration of the APP with outpatient follow-up affects clinical indicators and outcomes in individuals with CKD. As far as we know, this is the largest clinical trial evaluating remote management in patients with CKD. Based on the findings, there were no significant discrepancies noted in the rates of mortality or primary outcome of renal replacement therapy between the group that received APP + outpatient intervention and the traditional outpatient group. In contrast, the APP + outpatient group exhibited noteworthy enhancements in laboratory data such as Phosphorus, Sodium, Triglyceride and Hemoglobin. However, it is important to highlight that patients in advanced stages of CKD (stages 4–5) require strong emphasis on traditional outpatient follow-ups to adequately prepare for renal replacement therapy and reduce the need for temporary catheter usage when opting for HD.

The necessity of long-term follow-up management for CKD patients

CKD is a significant public health concern and poses a burden on healthcare systems due to its high incidence and prevalence, high rates of disability, substantial medical costs, and low levels of awareness. The Kidney Disease Improving Global Outcomes(KIDIGO) guidelines suggest that regular follow-up and comprehensive management can slow the progression of CKD alongside drug therapy [14]. Improving lifestyle behaviors, such as controlling salt or protein intake, adhering to medications and regular physical exercise, have been known to reduce the risk and progression[15, 16]. In 2013, our project team established a CKD management center with a follow-up system and explored various management models[16]. Five full-time nurses provided long-term outpatient follow-up and management services to enrolled patients, successfully achieving the goal of delaying CKD progression and improving patients' quality of life. However, the sudden outbreak of COVID-19 in 2019 posed a challenge to the original CKD outpatient follow-up model. It was imperative to explore and leverage "Internet + " technology for remote follow-up[17] Therefore, we developed the Suyi APP based on patients' self-management capabilities, which enabled remote management during the epidemic control measures.

Utilizing APP for outpatient follow-up can help improve patient health outcomes

APP interventions have the benefits of being multifunctional, including communicating with and collecting information from users as well as providing interactive experiences[18]^,[19]. APP interventions provide a platform for the delivery of adherence interventions that are considered to be highly customizable to each unique individual, available at low cost, and easily accessible[20]. Using internet technology to develop information means for multichannel follow-up intervention is of great significance to prevent the occurrence of CKD and the progression of end-stage kidney disease[21]. Tuot believes that telemedicine could improve knowledge and behavior changes for CKD patients and primary care providers[22]. Kelly’s study on coaching to promote healthy eating in patients by phone and text message was an available intervention that appears feasible for supporting dietary self-management in stage 3–4 CKD[23]. Blood pressure[24] and diet quality[25] of early patients were effectively improved after short-term, intensive and remote dietary APP intervention, decreased acid production and potentially mitigated CKD progression[26]. These findings demonstrate that app intervention can improve patients’ self-care and medication adherence by providing appropriate lifestyle, nutrition and medication guidance. The Suyi APP for CKD, which is based on the patient's self-management capabilities, includes modules for health data tracking, receiving medication information, appointment reminders, and home self-management, enabling patients to effectively self-manage at home. By combining internet technology with traditional outpatient follow-up management, coordination between healthcare providers and patients is improved, providing patients with more comprehensive healthcare services and significantly improving their clinical outcomes. However, in the retrospective selection of patients for the program, we found that its success depends on several key factors, including the design and functionality of the APP, patient health education, and the level of support and follow-up provided by healthcare providers. Additionally, patient willingness to accept and use the APP is crucial. In conclusion, the development and application of the APP, along with outpatient follow-up management, can positively impact the health outcomes of CKD patients and improve nursing quality.

CKD stages 4–5 require more frequent face-to-face outpatient follow-up care

In stage 4–5 of CKD, the kidneys are more severely damaged, often accompanied by uremia and other serious complications, including cardiovascular disease, osteoporosis, and anemia. When it is necessary to enter kidney replacement therapy, patients need to choose their treatment plan.The choice of RRT is a critical decision that has a great impact on the lives of both patients and their families, so it is advisable to practice shared decision-making when trying to choose the best treatment[27, 28]. Face-to-face health education for outpatient follow-up could facilitate more communication and build better relationships between patients, family members, and healthcare team members[29, 30]. For patients with ESKD entering HD, the best vascular access is an autologous arteriovenous endovascular fistula, a prosthetic vessel, or a temporary catheter if long-term vascular access is not ready at the time of entry into HD. Numerous studies have shown that the risk of bloodstream infection with a temporary catheter is 7.64 times higher than that with an autologous arteriovenous fistula[29], and the high rates of mortality immediately after ESKD were mostly accounted for by the HD with catheter population[30, 31]. Studies have demonstrated that participation in predialysis face to face education resulted in lower initiation of emergency dialysis through the use of temporary catheters[32]. The findings of this study confirm that the use of temporary catheters during the first hemodialysis is decreased in patients who have received traditional outpatient follow-up. Next, it is necessary to further develop an information-based decision-making support tool for renal replacement therapy.

Limitations

The current study has several limitations. First, it was a single-center observational study, and the long-term efficacy of app intervention through our CKD management program could not be definitively demonstrated. Second, patients have different cultural literacy and abilities to acquire knowledge from apps, and many elderly patients cannot proficiently use apps. More data from patients are needed, and the long-term effects of app intervention need to be investigated in a larger cohort of patients. Additionally, future directions for telemedicine use and research and quality measurement need to be explored.

Comparison with Prior Work

On the one hand, previous studies focused more on the development and verification of the effectiveness of APP in clinical use, without analyzing and comparing how to use APP in specific clinical situations. By comparing the use of the same APP in different clinical situations, this study confirmed that the APP should cooperate with clinical application. If APP is to be used for simple remote follow-up, its personalized functions and settings need to be further improved. On the other hand, most prior studies have relied on limited sample sizes, short follow-up times and different research objectives. To the best of our knowledge, our study is the largest clinical trial evaluating remote management in patients with CKD, and the follow-up time was up to 3 years.

CKD

Chronic Kidney Disease

APP

application program

Hemodialysis

Peritoneal Dialysis

Renal Transplant

IPTW

Inverse Probability of Treatment Weighting

ASD

absolute standardized difference

IQR

inter-quartile range

BMI

body mass index

SBP

systolic blood pressure

ACEI

angiotensin converting enzyme inhibitor

ARB

angiotensin receptor blocker

ACR

Albumin-to-creatinine ratio

EPO

erythropoietin

NASIDs

non-steroidal anti-inflammatory drugs

risk difference

hazard ratio

RRT

renal replacement therapy

CVC

central venous catheter

TCC

tunnel-cuffed catheter

AVF

Arteriovenous Fistula

Ethics approval and consent to participate

The Medical Ethics Committee of Second Affiliated Hospital of Army Medical University of Chinese People's Liberation Army approved this study with a specific ID 2018-R006-01. All methods were carried out in accordance with relevant ethics guidelines and regulations. Informed consent was obtained from all subjects and/or their legal guardians for this study.

Consent for publication

Not applicable.

Availability of data and materials

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Competing interests

The authors declare that they have no competing interests.

Funding

This work was supported by the Chongqing Municipal Science-Technology Bureau and Health Commission jointly funded the project [grant numbers 2022MSXM026, 2022].

Authors' contributions

Yu Shi and Shi Pu were carried out the literature search. Hongmei Peng, Shi Pu, Yang Li, Xia Huang collected the data of the patients.Yu Shi and Jing Zhang were responsible for the development of the APP. Yu Shi and Shi Pu analyzed the case and wrote the manuscript. Yu Shi and Yu Luo conceived the study, participated in the study design. Yu Luo and Caiping Song provided critical input in drafting and reviewing the manuscript. All authors have read and approved the final manuscript.

Acknowledgments

The aouthors would like to thank the patients who participated in this study and volunteers assisted the process of recruiting patients.

Authors' information

Department of Nephrology, The Second Affiliated Hospital of Army Medical University (Third Military Medical University), Chongqing, 400037, P.R. China.

Yu Shi (ORCID：0000-0002-2983-5613)& Shi Pu & Hongmei Peng & Xia Huang & Yang Li

Thinemed Medical Technology（Chongqing）Co.,LTD, Chongqing, 401121, P.R. China.

Jing Zhang

President Office, The Second Affiliated Hospital of Army Medical University (Third Military Medical University), Chongqing, 400037, P.R. China.

Caiping Song , E-mail: [email protected]

School of Nursing, Army Medical University (Third Military Medical University), No. 30 Gaotanyan Street, Shapingba District, Chongqing, 400038, P.R. China.

Yu Luo (ORCID：0000-0002-3566-3766) , E-mail: [email protected]

Yu Shi and Shi Pu contributed equally

Yu Luo and Caiping Song are Co-corresponding author

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Tables 2 to 5 are available in the Supplementary Files section.

No competing interests reported.

Table25.xls

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02 May, 2024
Reviews received at journal
13 Sep, 2023
Reviewers agreed at journal
04 Sep, 2023
Reviewers invited by journal
28 Aug, 2023
Editor assigned by journal
08 Aug, 2023
Submission checks completed at journal
06 Aug, 2023
First submitted to journal
04 Aug, 2023

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Impact of Mobile Application and Outpatient Follow-up on Renal Endpoints and Physiological Indices in Patients with Chronic Kidney Disease: A Retrospective Cohort Study in Southwest China

Status:

Journal Publication

Version 1

Abstract

Background

Methods

Results

Conclusion

Figures

Introduction

Methods

Mobile App Development

Study design

Setting

Participants

Outcome measurement

Bias

Study size

Statistical methods

Results

Study participants

Descriptive data

Evaluation Outcomes

Laboratory data

All-cause mortality outcomes

Renal replacement therapy outcomes

Temporary dialysis catheter outcomes

Discussion

The necessity of long-term follow-up management for CKD patients

Utilizing APP for outpatient follow-up can help improve patient health outcomes

CKD stages 4–5 require more frequent face-to-face outpatient follow-up care

Limitations

Comparison with Prior Work

Conclusions

Abbreviations

Declarations

Consent for publication

Availability of data and materials

Competing interests

Funding

Authors' information

References

Tables

Additional Declarations

Supplementary Files

Status:

Journal Publication

Version 1