Intelligent wearable-enhanced WeChat platform with multidisciplinary tele-rehabilitation reduces caregiver burden and psychological distress in congenital pseudarthrosis of the tibia: a randomized controlled trial

Introduction

Congenital pseudarthrosis of the tibia (CPT) is a challenging and highly disabling congenital condition in newborns (1,2). Affected infants often present with pathological fractures of the tibia at birth or shortly thereafter, which fail to heal spontaneously, leading to the formation of a pseudarthrosis. The incidence of CPT is approximately 1 in 140,000 (1,2), but nearly half of the patients experience complications such as refractures and limb deformities after surgery, with about 40% ultimately requiring amputation (3). The recurrent surgical complications and high risk of amputation associated with CPT severely impact the physical and psychological health of affected children and impose a significant burden on families and society. Our previous research has identified that CPT patients impose a caregiving burden on parents, and factors such as caregivers’ work conditions and average family income influence family resilience scores (4). Caring for children with chronic conditions often leads to a decline in the quality of life for family members and the psychological health of parents. Therefore, identifying effective interventions to alleviate these symptoms in parents of CPT patients is crucial. We present this article in accordance with the CONSORT reporting checklist (available at https://mhealth.amegroups.com/article/view/10.21037/mhealth-25-42/rc).

Methods

This study was approved by the Ethics Committee of Hunan Children’s Hospital (No. KYSQ2021-035). This study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. Additionally, all parents and/or legal guardians of the patients signed informed consent forms before participating in the study. Our trial was registered in the Chinese Clinical Trial Registry (ChiCTR2500066877).

Study design

A prospective randomized controlled study was conducted in our hospital from January 2022 to June 2023. The significance level was set at α=0.05 and the test power at 1−β=0.80. According to the pre-experimental data, the expected mean difference δ in the primary outcome (such as the family caregiver burden score) between the intervention group and the control group was 5.0 points, and the pooled standard deviation σ was 8.2. Through the formula calculation, it was found that 34 effective samples were required for each group (n=2×((Zα/2+Zβ)²×σ²)/δ²+10% contingency). Considering a 10% loss to follow-up rate, the final total sample size was determined to be 76 cases. A total of 78 participants were recruited (Figure 1). The research team assigned numbers to the parents of children with CPT and used a random number table to allocate them into two groups: a control group and a WeChat group, with a 1:1 ratio. This study adopted an assessor-blinded randomized controlled design. Although participants and healthcare providers were aware of the group assignments due to the intervention nature, outcome assessors and data analysts were blinded throughout the trial. Post-discharge, the WeChat group received remote follow-up management via WeChat, while the control group received traditional outpatient follow-up management. On the day of discharge and at 6 months post-discharge, the Family Caregiver Task Inventory (FCTI) was used to assess caregiving burden. Additionally, the Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS) were employed to evaluate the negative emotions of the parents of children with CPT. The Pittsburgh Sleep Quality Index (PSQI) was used to evaluate the sleep conditions of the parents. Throughout the study, no serious adverse events were reported in either group.

Figure 1 CONSORT flow diagram of participant enrollment, randomization, and follow-up. FCTI, Family Caregiver Task Inventory; PSQI, Pittsburgh Sleep Quality Index; SAS, Self-Rating Anxiety Scale; SDS, Self-Rating Depression Scale; SEC, standard education and care; WPIM, WeChat-platform intelligent management.

Inclusion and exclusion criteria

Inclusion criteria were: (I) parents of children diagnosed with CPT at the hospital, with the parents being the primary caregivers; (II) parents with a smartphone capable of using WeChat; (III) parents who voluntarily participated in the study and committed to regular follow-up. Exclusion criteria were: (I) parents with a history of mental illness or cognitive-behavioral abnormalities; (II) parents who are unable to use WeChat; (III) parents unwilling to participate in the study.

Standard education and care (SEC) group: on the day of discharge, CPT patients or their parents received a health manual provided by a specialized nurse, which contained the same information as that given to the WeChat-platform intelligent management (WPIM) group. Subsequently, follow-up calls were made every two weeks to the parents of the child, with a requirement for outpatient follow-ups every three months.

WPIM Group: for patients in the WPIM group, a comprehensive WeChat-based health education and perioperative care program was implemented. This program combined the real-time communication capabilities of WeChat groups with the information-sharing features of WeChat Official Accounts, aiming to provide patients and their families with thorough and timely support and education. The specific measures included:

• Establishment of WeChat group and official account:
  • Creation of a WeChat group, with invitations extended to professionals from departments such as Rehabilitation and Nutrition, to offer specialized guidance.
  • Patients and parents, upon agreeing to participate in the study, were invited to join the WeChat group and ensured they understood the basic use of WeChat groups and the Official Account.
  • Through the WeChat Official Account, patients and families had access to relevant health information related to the disease at any time.
• Preoperative care and education:
  • Detailed explanations of the treatment plan, surgical procedure, and rehabilitation plan were provided preoperatively to boost confidence and alleviate fear.
  • Knowledge related to orthopedic surgery was disseminated via the WeChat Official Account, with nightly reminders in the WeChat group about perioperative care.
  • Risk assessment and education were conducted for high-risk patients based on their condition, with video education guiding patients towards active treatment of the primary disease.
  • Preoperative pain management education was provided, including methods for pain relief and a planned multimodal analgesia strategy during the perioperative period.
  • Guidance was given on preoperative fasting, allowing non-solid foods up to 6 hours before surgery and a 10% glucose solution up to 4 hours before, with personalized postoperative nutritional support plans based on food preferences.
• Postoperative care and support:
  • Post-surgery, the WeChat Official Account emphasized the prevention of complications, enhancing patients’ self-management skills and crisis awareness.
  • Patients were encouraged to engage in under-bed activities and appropriate functional exercises, with nursing staff creating and sharing rehabilitation exercise videos to highlight the importance of early mobilization.
  • All nursing staff received training on pain management and explained the use and potential side effects of pain pumps via video education.
• Discharge guidance and ongoing support:
  • Upon discharge, patients received a detailed health manual, with a professional nurse explaining its contents, including postoperative care, dietary advice, and medication management.
  • The WeChat group continued to provide articles, short videos, or cartoons related to osteosarcoma to help patients and families better understand the disease and recovery process.
  • The WeChat Official Account served as an information-sharing platform, allowing patients and families to access previously shared information and resources.
  • Trained nurses offered online consultation and education services through the WeChat Official Account and group, addressing questions, providing psychological support, and assisting with outpatient appointments.

This integrated approach aims to leverage modern information technology to offer comprehensive and continuous support and education, promoting patient recovery and enhancing quality of life.

• Smartwatch: the smartwatch is equipped with high-precision sensors that can monitor the patient’s posture during exercise.
  • First stage: early postoperative period (1–2 weeks)
    The goal is to promote wound healing, restore basic activity ability, and avoid excessive load. Reminded by the smartwatch, patients should perform 3–4 sets of isometric contraction exercises of leg muscles, such as the quadriceps femoris and triceps surae, 10–15 times per set, every day. Within the range allowed by the external fixator, perform slight movement exercises of the ankle and knee joints, 2–3 sets per day, 5–10 times per set.
  • Second stage: middle postoperative period (3–6 weeks)
    Gradually increase muscle strength, expand the range of joint motion, and prepare for weight-bearing walking. Supervised by the smartwatch, increase the intensity and duration of muscle contractions. In addition to isometric contraction exercises, start some simple isotonic contraction exercises, such as straight leg raises, 3–4 sets per day, 8–12 times per set. Use the angle monitoring function of the smartwatch to assist in the flexion and extension exercises of the knee and ankle joints, 3–4 sets per day, 10–15 times per set, and gradually increase the range of joint motion.
  • Third stage: late postoperative period (7–12 weeks)
    Begin partial weight-bearing training to improve the balance and coordination ability of the lower limbs. The smartwatch can record the number of steps, distance, and time of walking. Walk 2–3 times a day, 5–10 minutes each time. Perform balance exercises such as standing on one leg and using a balance board, 2–3 sets per day, 3–5 minutes per set.
  • Fourth stage: 13 weeks or more after surgery
    Walk with full weight-bearing and restore normal lower-limb function and exercise ability. Conduct some functional training related to daily life, such as going up and down stairs and squatting and standing up, 2–3 sets per day, 10–15 times per set. According to the patient’s recovery, gradually try some low-intensity sports activities, such as swimming and cycling. The smartwatch can monitor the heart rate, exercise time, and calories burned during exercise to ensure the safety and effectiveness of the exercise.

Assessment criteria

We used the FCTI to evaluate the family caregiving burden experienced by parents of children with CPT. The FCTI encompasses five assessment domains: adaptation to caregiving roles, capacity to provide assistance, handling personal emotions, assessing family and community resources, and adjusting life to meet caregiving needs. Scores range from 0 to 3, where 0 indicates “very easy” and 3 indicates “very difficult”. The SAS and the SDS were employed to assess the severity of anxiety and depression symptoms. Both scales are widely used in clinical and research settings. Each scale consists of 20 items, covering various aspects of anxiety and depression symptoms. Each item has four response options (“rarely”, “sometimes”, “often”, and “always”), corresponding to scores ranging from 1 to 4. The total score ranges from 20 to 80, with higher scores indicating more severe symptoms. The PSQI consists of 18 self-rated items that are grouped into seven components: sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. Each component is scored on a scale of 0–3 points. The cumulative score ranges from 0 to 21 points. A total score greater than 7 points indicates poor sleep quality.

Statistical analysis

After organizing the general information and collected scale data of CPT patients’ parents, statistical analysis was performed using SPSS version 25.0 (IBM). Measurement data were presented as mean ± standard deviation. Differences between groups were compared using Chi-squared tests and Student’s t-tests. The level of statistical significance was set at P<0.05.

Results

Demographic characteristics

The demographic characteristics of caregivers of children with CPT are summarized in Table 1. Specifically, there were no statistically significant differences between the control group and the WeChat group regarding caregiver gender, caregiver age, single-child family status, caregiver educational background, medical payment methods, or average monthly family income over the past year (Table 1).

Family caregiving burden for parents of children with CPT

The FCTI was used to assess the caregiving burden of parents of children with CPT. Prior to the intervention, there were no statistically significant differences between the control group (33.75±1.15) and the WeChat group (33.13±1.61) in FCTI scores (P>0.05). After 6 months of intervention, the FCTI score for the WeChat group (20.63±0.49) significantly decreased compared to the control group (25.75±0.70), with a statistically significant difference (P<0.05). FCTI: between-group difference =5.12 points (95% confidence intervals: 3.45 to 6.79) (Table 2).

Negative emotion scores of parents of children with CPT

The SAS and the SDS were used to evaluate the negative emotions of parents of children with CPT. Before the intervention, there were no statistically significant differences in SAS scores between the control group (60.5±1.44) and the WeChat group (61.88±1.25) (P>0.05). Similarly, there were no statistically significant differences in SDS scores between the control group (58.38±1.46) and the WeChat group (57.5±1.50) (P>0.05). After 6 months of intervention, the SAS score for the WeChat group (43.13±1.03) significantly decreased compared to the control group (51.38±0.86), with a statistically significant difference (P<0.05). Additionally, the SDS score for the WeChat group (49.63±0.59) significantly decreased compared to the control group (53.38±0.94), with a statistically significant difference (P<0.05). SAS: between-group difference =8.25 points (95% confidence intervals: 5.98 to 10.52). SDS: between-group difference =3.75 points (95% confidence intervals: 1.89 to 5.61) (Table 3).

Sleep quality of parents of children with CPT

The PSQI was used to assess the scores of fathers or mothers of children with CPT. No significant difference was found between the two groups before the intervention. Six months after the intervention, the score of the WeChat group (6.5±2.4) was significantly lower than that of the control group (9.7±3.2), and the difference was statistically significant (P<0.05). PSQI: between-group difference =3.2 points (95% confidence intervals: 1.6 to 4.8) (Table 4).

Discussion

Due to the progression of the disease and difficulties in bone healing, children with CPT often require surgical intervention. Our institution is currently the leading facility globally in treating CPT, performing approximately 80 CPT surgeries annually and effectively following up with over 500 cases (5). We have previously confirmed that combined surgical approaches—such as lesion debridement, encapsulated bone grafting, intramedullary nailing, and Ilizarov external fixation—significantly improve fracture union rates and quality of life for CPT patients (6,7). However, these combined surgeries significantly increase the complexity of care. Firstly, in addition to the approximately 10 cm surgical incision on the lower limb, a 5 cm bone graft extraction incision is required on the contralateral iliac bone, and multiple pin tracks are present on the external fixation device. The distribution of these incisions on both sides of the child severely restricts their ability to rest in bed and change positions. Additionally, the prolonged surgical time, considerable intraoperative blood loss, and significant pain make postoperative nutritional and pain management care crucial. Secondly, Ilizarov external fixation involves multiple pin tracks on the lower limb, and improper care can easily lead to fixation displacement or pin tract infections. Lastly, the young age of CPT patients, who cannot effectively communicate, presents an additional challenge for caregivers. Given the nursing difficulties faced by CPT patients’ post-surgery, it is essential to explore new approaches to alleviate the caregiving burden and anxiety experienced by caregivers.

Based on WeChat educational and care programs have demonstrated significant efficacy in delivering rehabilitation plans, receiving widespread attention for effectively addressing the spatial and temporal limitations of medical services (8,9). WeChat-based health education, combined with postoperative recovery models, can significantly enhance orthopedic patients’ knowledge, accelerate limb function recovery, and reduce the incidence of postoperative complications (10). Similarly, Yang et al. have shown that WeChat follow-up management effectively improves the quality of life for parents of premature infants with patent ductus arteriosus (11). Furthermore, WeChat-based interventions can serve as an innovative approach to providing rehabilitation methods and have gained broad recognition (12).

Wu et al. reported that using WeChat, an effective communication platform, can significantly reduce anxiety, depression, and post-traumatic stress disorder in parents of patients with osteosarcoma (13). Research indicates that WeChat interventions can notably decrease anxiety and depression in parents of children and adolescents (14,15). In our study, the WPIM program—which includes establishing WeChat groups and public accounts, preoperative care and education, postoperative care, discharge guidance, and ongoing support—demonstrated that parents in the WPIM program had lower levels of anxiety and depression compared to those in the SEC program. Possible reasons include: (I) The convenience and flexibility of the WeChat platform allow parents of CPT patients to continuously access disease-related information after discharge, aiding in their child’s rehabilitation and medication management (16); (II) WPIM enhances psychological education for parents through the online public account, enabling them to easily understand their psychological issues and adopt appropriate coping strategies (17); (III) The one-on-one or group chat mode of WeChat allows parents to promptly contact healthcare professionals for advice and exchange experiences with other parents, reducing negative emotions (16); (IV) WPIM facilitates interaction among parents, helping them share learning experiences, release negative emotions, and gain mutual encouragement (18). Overall, the WeChat platform demonstrates significant advantages in optimizing rehabilitation plans and improving caregiver mental health. Wearable sensors such as smartwatches have demonstrated excellent monitoring and guiding capabilities during limb function exercises for stroke patients and in collecting electrocardiogram and walking data of patients during cardiac rehabilitation. They can effectively accelerate the patients’ postoperative rehabilitation process (19,20). The intervention of wearable sensors like smartwatches and devices such as WeChat has significantly alleviated the burden on caregivers. Wearable sensors can automatically and continuously monitor multiple physiological indicators of children patients, including heart rate and body temperature. Caregivers no longer need to conduct frequent manual measurements, which saves their time and energy. Moreover, they can check the data at any time to understand the health status of the children’s patients, reducing concerns caused by untimely or inaccurate measurements. For example, caregivers can rest assured at night as the devices keep monitoring. While our model provided structured guidance and monitoring, it cannot fully replicate the hands-on, tactile feedback and immediate corrective maneuvers of a physiotherapist in a dedicated rehabilitation facility. The intervention’s effectiveness relied on the parents’ ability to correctly facilitate the exercises, which may vary. However, for the specific postoperative protocol in this study—which emphasized controlled, graded exercises in the presence of an external fixator—the combination of real-time wearable data and video guidance from our multidisciplinary team proved to be a safe and feasible alternative. This approach effectively bridged the gap between hospital discharge and full functional recovery for most patients in our cohort, without any reported adverse events related to the remote guidance itself.

On the other hand, social devices like WeChat provide a convenient communication and help-seeking channel for caregivers. When encountering nursing problems, they can consult medical staff at any time to obtain professional guidance. They can also exchange experiences and support each other with other caregivers, which helps relieve psychological stress, so that caregivers are no longer left alone and can handle the challenges of taking care of children patients more calmly. It is important to note that our study has some limitations. First, this was a single-center trial conducted in a specialized pediatric orthopedic center, which may limit the generalizability of our findings to other settings or populations. Although our sample size was adequate for detecting statistically significant differences, future multi-center studies with larger and more diverse samples are needed to validate our results. Second, the intervention relied heavily on digital literacy and access to smartphones and wearables, which may not be equally available across all socioeconomic groups. Parents with lower educational backgrounds or limited technological familiarity may benefit less from such interventions. Third, the follow-up period was limited to 6 months; longer-term studies are necessary to evaluate the sustained effects of the intervention on caregiver burden and mental health, as well as on the functional outcomes of the children. Fourth, this study was designed with a primary focus on the caregiver as the unit of analysis and intervention. Therefore, while we tracked major adverse clinical events, we did not systematically collect patient-centered functional outcomes, such as detailed radiographic union scores, range of motion, or standardized functional assessments. Consequently, our study cannot definitively establish a direct link between the reduction in caregiver burden and specific enhancements in the child’s physical recovery. Finally, while we observed significant improvements in psychological outcomes, the mechanisms underlying these changes warrant further investigation through qualitative or mixed-methods research.

Conclusions

WeChat-based remote management alleviates the caregiving burden and anxiety for parents of CPT children.

Acknowledgments

We are grateful to all the patients who accepted to participate in this study.

Footnote

Reporting Checklist: The authors have completed the CONSORT reporting checklist. Available at https://mhealth.amegroups.com/article/view/10.21037/mhealth-25-42/rc

Trial Protocol: Available at https://mhealth.amegroups.com/article/view/10.21037/mhealth-25-42/tp

Data Sharing Statement: Available at https://mhealth.amegroups.com/article/view/10.21037/mhealth-25-42/dss

Peer Review File: Available at https://mhealth.amegroups.com/article/view/10.21037/mhealth-25-42/prf

Funding: This work was supported by the Special Found of the Hunan Provincial Key Laboratory of Pediatric Orthopedics (No. 2023TP1019).

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://mhealth.amegroups.com/article/view/10.21037/mhealth-25-42/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. This study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the Ethics Committee of Hunan Children’s Hospital (No. KYSQ2021-035). Informed consent was obtained from the parents and/or legal guardians of the patients.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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