This paper is in the following e-collection/theme issue:

Caregiving and Parenting for Chronic Pediatric Diseases (111) Web-based and Mobile Health Interventions (3986) Mental Health Issues in Adolescence (622) Mobile Apps for Chronic Disease Management in Childhood and Adolescence (48) Supporting Home Care and Family Caregivers (257) Engagement with and Adherence to Digital Health Interventions, Law of Attrition (627)

Published on in Vol 8 (2025)

Preprints (earlier versions) of this paper are available at https://preprints.jmir.org/preprint/67102, first published .
Enhancing Adherence and Mental Well-Being in Pediatric Growth Hormone Therapy: Feasibility Prospective Observational Study of a Family-Centered Digital Companion

Enhancing Adherence and Mental Well-Being in Pediatric Growth Hormone Therapy: Feasibility Prospective Observational Study of a Family-Centered Digital Companion

Enhancing Adherence and Mental Well-Being in Pediatric Growth Hormone Therapy: Feasibility Prospective Observational Study of a Family-Centered Digital Companion

Authors of this article:

Antonio de Arriba Muñoz1, 2 Author Orcid Image ;   Amalia M García-Durán1, 2 Author Orcid Image ;   Patricia Sanz-Aznar1, 2 Author Orcid Image ;   Silvia Quer-Palomas3 Author Orcid Image ;   Ioannis Bilionis3 Author Orcid Image ;   Alba Xifra-Porxas3 Author Orcid Image ;   Joia Nuñez3 Author Orcid Image ;   Ricardo C Berrios3 Author Orcid Image ;   Luis Fernández-Luque3 Author Orcid Image
Article Authors Cited by Tweetations Metrics

    1Endocrinology Pediatric Unit, Hospital Universitario Miguel Servet, Zaragoza, Spain

    2Instituto de Investigación Sanitaria de Aragón, Zaragoza, Spain

    3Adhera Health Inc, 101 Cooper St, Santa Cruz, CA, United States

    Corresponding Author:

    Luis Fernández-Luque, PhD


    Background: Managing a child undergoing growth hormone treatment (GHt) can be burdensome for the families, which can lead to psychological problems and poor treatment adherence. The Adhera Caring Digital Program (ACDP) is a mobile-based digital health intervention designed to support the physical and mental well-being of families of individuals with chronic conditions.

    Objective: This study aimed to evaluate the clinical feasibility of a digital intervention to support families by focusing on caregivers of children undergoing GHt and its impact on treatment adherence.

    Methods: This is a prospective observational study. A total of 51 caregivers of children undergoing GHt with low adherence (below 85%) to treatment were recruited at the Pediatric Endocrinology Unit at the Miguel Servet Children’s University Hospital and enrolled into the ACDP for 3 months.

    Results: A total of 51 parents participated in the digital intervention for 3 months. The use of ACDP was associated with a significant increase in adherence rate (P<.001). At baseline, all families had suboptimal adherence (below 85%), and after the intervention, 75% (n=38) of the families reached optimal levels of adherence. Also, the perceived pain of injection was reduced, as well as anxiety and stress. Initially, 21.56% (n=11) of caregivers reported depression symptoms, categorized as mild (11.76%, n=6), moderate (7.84%, n=4), and extremely severe (1.96%, n=1), while post intervention, only 1.96% (n=1) of caregivers reported depression as “severe.” Anxiety levels at baseline were reported by a total of 23.53% (n=12) of caregivers (mild: 7.84%, n=4, moderate: 13.73%, n=7, and severe: 1.96%, n=1). After the intervention, only 11.76% (n=6) reported mild (5.88%, n=3) or moderate (5.88%, n=3) anxiety levels. Initially, 23.5% (n=12) of caregivers reported stress as mild (7.84%, n=4), moderate (13.72%, n=7), and severe (1.96%, n=1) stress, and following the intervention, these symptoms reduced to 7.84% (n=4) (mild: 5.88%, n=3, severe: 1.96%, n=1).

    Conclusions: The ACDP is a promising tool, and it has been demonstrated to significantly increase the adherence rate, adding value to the patient and caregiver journey, and improving the management of growth hormone deficiency while promoting the overall well-being of family caregivers. Our results show that the digital support provided by the solution significantly increased the quality of life of the caregivers by increasing their psychological, emotional, and social well-being and decreasing their depression, anxiety, and stress symptoms.

    Trial Registration: ClinicalTrials.gov NCT04812665; https://clinicaltrials.gov/study/NCT04812665

    JMIR Pediatr Parent 2025;8:e67102

    doi:10.2196/67102

    Keywords

    growth hormone; hormone therapy; caregiver fatigue; well-being; pediatric; paediatric; digital health; digital intervention 


    Background

    Growth hormone (GH) deficiency (GHD) in the pediatric population causes short stature [1]. Children affected by GHD have also been reported to have worse quality of life, cognitive function, and fatigue than those with normal height [2,3]. Short stature in children is also associated with anxiety, depression, and social withdrawal [4-11]. Importantly, recent findings suggest that poor emotional well-being and health-related quality of life (HrQoL) of caregivers and/or parents are also negatively related to children’s HrQoL, particularly in the context of pediatric health conditions.

    These children’s families are responsible for managing the disease. Within the family, family caregivers are the ones managing its treatment (daily injections of recombinant human GH) and the children’s mental health. Caring might be burdensome and challenging [12,13], exposing the family caregiver to the risk of developing psychological problems [14]. Indeed, parental stress has been described as one of the consequences of managing GHD in children, leading to poorer adherence to GH therapy (GHt) and an impact on their environment and health [15,16]. Overall, family caregiver fatigue has been found to significantly impact the well-being of the caregiver and the patient living with a chronic condition [17]. However, the impact of the family caregiver specifically on GHDs remains unclear [18,19].

    Digital health (DH) solutions are transforming the health care sector, as they can be a cost-effective option that allows accessible family-centered and personalized interventions. Indeed, mobile interventions have been proven effective in supporting caregivers in the management of chronic conditions [20]. One such innovation is the Easypod system, an electronic, fully automated device designed to streamline the GH treatment process. This system provides reliable real-time injection data, enabling health care providers to monitor patients’ progress and make more informed treatment decisions. By identifying nonadherent patients earlier, the Easypod allows for more targeted support, enhancing both treatment adherence and outcomes [21].

    The Adhera Caring Digital Program

    The Adhera Caring Digital Program (ACDP) is a comprehensive, digitally delivered program designed to support the physical and mental well-being of family caregivers of individuals with chronic conditions. It aims to improve self-management and health outcomes for both the patient and their family caregiver [22]. The ACDP includes access to a mobile app for family caregivers, which is integrated into an artificial intelligence–powered platform that includes integrated data from injector devices, as well as tools for supporting clinicians to follow up on the health of the families.

    This study aimed to evaluate the clinical feasibility of a digital intervention to support families by focusing on caregivers of children undergoing GHt and its impact on treatment adherence.

    Previous Research

    GHt for children is a critical yet challenging process that often demands significant effort from family caregivers. The burden of managing GHt can negatively impact the psychological well-being of caregivers and adherence to the treatment protocol, which, in turn, affects the health outcomes of the children undergoing treatment. This challenge necessitates the development of effective support systems for caregivers to ensure better adherence and overall health outcomes.

    Recent advancements in digital health interventions have shown promising results in supporting caregivers of children with chronic conditions, including those undergoing GHt. Studies have demonstrated that digital tools can provide substantial benefits by improving treatment adherence and enhancing the mental health of caregivers. For instance, a recent study by Dimitri et al (2021) [23] found that digital interventions could significantly enhance treatment adherence in children with GHDs by providing real-time support and monitoring capabilities.

    In another study, Savage et al [13] highlighted the transformative potential of DH platforms in pediatric endocrinology, emphasizing how patient-generated data and interactive support can lead to more integrated and personalized care models. This approach improves not only adherence but also the overall quality of care provided to patients.

    The mental health and well-being of caregivers are crucial factors in ensuring successful GHt management. Zhai et al [24] reported the positive impact of DH interventions on reducing caregiver stress and anxiety, which, in turn, improved their ability to manage the treatment regimen effectively [24]. These findings underscore the importance of addressing the psychological needs of caregivers through innovative digital solutions.

    Additionally, Lorca-Cabrera et al [25] explored the role of mobile health applications in supporting self-management and emotional well-being among caregivers. Their research showed that these applications could reduce the psychological burden on caregivers, thereby improving their overall quality of life and enhancing their capacity to support their children’s treatment [25].

    The ACDP builds upon these foundations by offering a comprehensive digital health intervention designed to support the physical and mental well-being of caregivers managing children undergoing GHt. This study aims to evaluate the clinical feasibility of ACDP and its impact on treatment adherence, contributing to the growing body of evidence supporting the integration of DH solutions in chronic disease management.


    Overview

    Family caregivers (ie, parents) of children with suboptimal adherence to GHt were recruited to the study at the Pediatric Endocrinology Unit at the Miguel Servet Children’s University Hospital and were provided with access to the ACDP for 3 months. The protocol was prospectively registered in ClinicalTrials.gov (NCT04812665).

    Participants were assessed twice (at recruitment and at 3 months’ follow-up). The data collected were (1) demographic data (only at recruitment); (2) positive mood assessed with the Positive and Negative Affect Schedule (PANAS) [26]; (3) distress assessed using the Depression Anxiety and Stress Scale-21 (DASS-21) [27], general well-being assessed using the Mental Health Continuum Short Form (MHC-SF) [28], and self-efficacy assessed using the Generalized Self-Efficacy Scale (GSES) [29]; (4) HrQoL assessed using the KIDSCREEN-10 [30] and the Quality of Life in Short Stature Youth (QoLISSY) [31]; and (5) GHt adherence (%) by Easypod-Connect.

    Recruitment

    The inclusion criteria were as follows:

    • Adherence to GHt monitored in the last month prior to enrollment indicates a ratio less than 85%.
    • Family caregivers (and legal guardians) of children who receive GHt in accordance with approved indications in Spain.
    • Explicit agreement on data sharing regarding adherence to GHt gathered through the Easypod-Connect.
    • Participants must be able to interact with mobile phones and be willing to install the mobile-based solution of the study in their smartphone.
    • Participants must sign the specific informed consent form for the study.

    Only one legal guardian per child can participate in the study.

    Procedure

    The ACDP is a noninvasive, digitally delivered intervention designed to support family caregivers of children with chronic conditions. Specifically tailored for the context of GHt, the ACDP offers condition-specific educational content, evidence-based caregiving strategies, and self-management tools to help caregivers monitor progress and remain engaged with their child’s treatment. To promote emotional well-being and adherence, the program delivers personalized motivational messages generated by an artificial intelligence–driven health recommender system. This system tailors its recommendations using both objective and patient-reported data: objective adherence data are collected via Easypod-Connect, an electronic auto-injector device that monitors and transmits GH administration data, while patient-reported outcomes are assessed at baseline and at 3-month follow-up using validated psychometric instruments (see Table 1). The ACDP is part of the Adhera Health Precision Digital Companion Platform [32], which has been developed using the best practices regarding data protection and quality management in accordance with the ISO (International Organization for Standardization) 27001 and ISO 13465 guidelines.

    Table 1. SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) table.
    ProceduresVisit 1 (baseline)Visit 2 (3 mo)Digital health intervention periodFollow-up (post intervention)
    Screening for inclusion criteria✓
    Informed consent✓
    Baseline HrQoLa questionnaire (QoLISSY)b✓
    Emotional well-being assessment (PANASc)✓
    Self-efficacy (GSESd)✓
    Adherence monitoring✓✓ (throughout intervention)✓
    Digital support program usage✓
    Child’s growth monitoring✓✓
    Caregiver’s QoLe follow-up (QoLISSY)✓✓

    aHrQoL: health-related quality of life.

    bQoLISSY: Quality of Life in Short Stature Youth.

    cPANAS: Positive and Negative Affect Schedule.

    dGSES: Generalized Self-Efficacy Scale.

    eQoL: quality of life.

    Statistical Analysis

    Participants’ questionnaire answers were digitally recorded through a Microsoft Forms form and extracted to a Microsoft Excel database. Descriptive analysis (means, SDs, and percentages) was used for demographic data. After checking the normality of each variable, pre-post P values of the psychometrics’ parameters were checked using the Student t and Wilcoxon tests.

    Ethical Considerations

    This study protocol was reviewed and approved by the Spanish Ethics Committee C.P.-C.I. PI20/494. Written informed consent was obtained from participants (or their parent/legal guardian/next of kin) to participate in the study.

    The privacy and confidentiality of all research participants were strictly maintained; all data were de-identified before analysis, and no personally identifiable information was collected or reported. Participants were not compensated for their participation in this study.


    Participants’ Characteristics

    A total of 65 parents provided informed consent. Of these, 14 were excluded from the analysis, as they did not access the digital intervention. The final sample’s (n=51) characteristics are described in Table 2. Participants were 42.14 (SD 5.78) years old on average, and the sample mostly comprised women (n=35, 68.6%). The average age of the child taken care of was 7.9 (SD 2.9) years, receiving GHt for 36.51 (SD 28.43) months. Regarding the education level, 15 (29.4%) caregivers hold a university degree, 20 (39.2%) have professional training, 12 (23.5%) finished high school, and 4 (7.8%) finished primary school.

    Table 2. Descriptive characteristics of the sample (N=51).
    CharacteristicValue
    Caregiver’s gender, n (%)
    Male16 (31.4)
    Female35 (68.6)
    Caregiver’s age (years), mean (SD)41.45 (7.59)
    Caregiver’s marital status, n (%)
    Single10 (19.6)
    Married33 (64.7)
    Divorced8 (15.7)
    Education, n (%)
    Primary education4 (7.8)
    Secondary education/high school12 (23.5)
    Professional training20 (39.2)
    University degree15 (29.4)
    Child’s gender, n (%)
    Male25 (49.0)
    Female26 (51.0)
    Child’s age (years), mean (SD)7.98 (2.98)
    Time under treatment (months), mean (SD)36.51 (28.43)

    Statistical Analysis

    Quality of Life of Children

    Almost all the psychometric questionnaires’ results showed significant differences (ie, P<.05) after using the ACDP for 3 months (Table 3 and Figure 1). General health and quality of life were significantly improved based on KIDSCREEN-10 [30] and QoLISSY [31] psychometrics. General and Social well-being also improved significantly, while emotional well-being has improved as QoLISSY emotional scale scores increased, and the PANAS [26] indicated a statistically significant increase in positive affect (mood) as well as a decrease in negative affect. Social well-being also enhanced significantly according to both MHC-SF [28] and QoLISSY questionnaires. Self-efficacy, assessed using the GSES [29], increased, as did the QoLISSY coping score.

    Table 3. Comparison of family caregiver characteristics at baseline and 3 months after the intervention
    VariableBaseline3 monthsStatisticP valueEffect size (η2)
    PANASa
    Positive Affect30.78±7.2736.53±8.65-4.5<.0010.115
    Negative Affect18.98±6.0214.57±4.1885<.0010.154
    DASS-21b
    Depression Scale2.98±3.151.45±2.10106<.0010.075
    Anxiety Scale2.41±1.951.24±1.61160<.0010.098
    Stress Scale5.71±3.153.06±3.18151.5<.0010.149
    MHC-SFc
    General wellbeing0.62±0.170.69±0.21363.0080.037
    Emotional wellbeing0.67±0.200.71±0.20241.150.011
    Psychological wellbeing0.67±0.180.72±0.23454.170.013
    Social wellbeing0.52±0.190.65±0.22-3.7<.0010.086
    GSESd31.31±5.5133.43±5.31336.040.036
    KIDSCREEN 10
    HRQoLe49.19±10.8260.89±16.86194<.0010.146
    General Health3.43±0.814.22±0.8140.5<.0010.191
    QoLISSYf
    HrQoL74.94±15.9380.67±14.46452.0480.034
    Emotional scale79.41±15.0782.35±13.53442.280.01
    Physical scale75.57±19.5181.94±18.38351.5.040.028
    Social Scale69.83±20.3577.72±18.15294.5.020.04
    Coping scale40.98±17.2548.48±21.32347.5.010.036
    Height-related beliefs scale78.31±25.9666.30±28.20208.5.0040.047
    Treatment scale53.54±17.7767.37±21.93197.5<.0010.107
    Child’s future scale73.63±25.5782.65±17.98290.5.040.04
    Effects of child’s short stature on family scale68.45±18.9477.72±18.20333.5.0090.059
    Treatment Adherence (%)80.09±4.8788.75±10.0398.5<.0010.232
    Treatment adherence ≥85%0 (0%)41 (80.4%)—g——

    aPANAS: Positive and Negative Affect Schedule.

    bDASS-21: Depression Anxiety and Stress Scale-21.

    cMHC-SF: Mental Health Continuum Short Form.

    dGSES: Generalized Self-Efficacy Scale.

    eHrQoL: health-related quality of life.

    fQoLISSY: Quality of Life in Short Stature Youth.

    gNot applicable.

    ‎
    Figure 1. Changes in quality of life in youth with short stature (baseline and 12 wk).
    Mental Well-Being of Parents

    After the ACDP, the participants showed a significant difference in all the QoLISSY subscales except for the emotional (P=.28) scales. Meaningful results were found in the physical and social dimensions and in the child’s future perception, coping, treatment, height-related beliefs, and effects of the child’s short stature on the family scale. Concerning the mental health symptoms, the depression (Figure 2), anxiety (Figure 3), and stress (Figure 4) symptoms measured by the DASS-21 were reduced after the 3-month digital intervention.

    Finally, the use of the ACDP was associated with a significant increase in the adherence rate (P<.001). At the baseline, all the families had suboptimal adherence (below 85%); after the intervention, 75% (n=38) of the families reached optimal levels of adherence. The QoLISSY item regarding perceived pain of injection was also reduced, which might explain that improved social well-being and reduced anxiety and stress were associated with reduced perceived pain from injection and overall contributed to improved adherence.

    ‎
    Figure 2. Depression symptoms of family caregivers (baseline and 12 wk).
    ‎
    Figure 3. Stress symptoms of family caregivers (baseline and 12 wk).
    ‎
    Figure 4. Stress symptoms of family caregivers (baseline and 12 wk).
    Adult Growth Prediction

    In this study, growth data (height) have been analyzed post hoc for studying the impact of the intervention on patients treated with GH in a post hoc explorative analysis phase. In this sense, patients’ growth estimations are calculated by means of deviation from baseline children’s growth charts, based on the participants’ adherence levels to GHt. Specifically, measurements of patients’ height were collected in four fixed time points: (1) 6 months before treatment, (2) start of treatment, (3) start of the study, and (4) 6 months after the start of the study. Finally, another important variable ΔHSDS (change in height standard deviation score) that has been computed is the change in height deviation values between consecutive time points. The impact of the intervention in the growth status was analyzed by focusing on the patients who switched from medium to high adherence (~70% of the participants). Thus, assuming that without participation in the study, the patients’ adherence levels would have been medium, and the overall effect on mean ΔHSDS was computed by comparing the 48-month estimations of medium-only (hypothetical) cases with the real situation (70% high and 30% medium adherence, based on data analysis).

    The average estimated ΔΗSDS value for patients with medium adherence was 0.9, while that of the real (70% high and 30% medium adherence) cases was 1.04. Hence, an increase of 0.14 was observed in terms of ΔHSDS, meaning that the average participant is going to grow more thanks to the intervention. In other words, the increase in ΔHSDS indicates a reduction in the height gap between the patient’s actual growth and the expected growth based on baseline charts. This suggests improved growth outcomes due to better adherence to the treatment.


    Principal Results

    The management of children undergoing GHt has been reported to be burdensome [14]; specifically, it can be a time-consuming and exhausting process as family caregivers need to (1) ensure that their children receive the injections at the right time and at the correct dosage while providing emotional support and (2) address any mental health issues that may arise. Family caregivers’ fatigue and stress can negatively influence treatment adherence and the child’s health [14,15]. This research contributes to the emerging work in supporting family caregivers of children undergoing GHt using digital tools [28] by showing that the ACDP can effectively empower family caregivers of children with GHD, including improvements in the well-being of both parents and children while promoting self-management of the condition.

    Participants have reported a better quality of life and general health, as well as improvements in key points such as cognitive symptoms, mood, and emotional and social well-being. Most families involved in the study achieved optimal levels of adherence after the study. We found a statistically significant increase in positive affect (from 30.78, SD 7.27 at baseline to 36.53, SD 8.65 at the 3-month follow-up) with a statistically significant decrease in negative affect (from 18.98, SD 6.02 to 14.57, SD 4.18), which was measured using the PANAS. Also, the MHC-SF revealed a statistically significant increase in general well-being (from 0.62, SD 0.17 to 0.69, SD 0.21), social well-being (from 0.52, SD 0.19 to 0.65, SD 0.22) and general self-efficacy (from 31.31, SD 5.51 to 33.43, SD 5.31), with an increase in emotional (from 0.67, SD 0.20 to 0.71, SD 0.20), and psychological well-being (from 0.67, SD 0.18 to 0.72, SD 0.23). KIDSCREEN-10 revealed a statistically significant increase in HrQoL (from 49.19, SD 10.82 at baseline to 60.89, SD 16.86 at the 3-month follow-up) and a statistically significant increase in general health (3.43, SD 0.81 to 4.22, SD 0.81). Regarding the quality of life of youths with short stature, we found a statistically significant increase in scores on the physical scale (from 75.57, SD 19.51 to 81.94, SD 18.38), social scale (from 69.83, SD 20.35 to 77.72, SD 18.15), coping scale (from 40.98, SD 17.25 to 48.48, SD 21.32), height-related beliefs scale (from 8.31, SD 25.96 to 66.30, SD 28.20), treatment scale (from 53.54, SD 17.77 to 67.37, SD 21.93), and child’s future scale (from 73.63, SD 25.57 to 82.65, SD 17.98), as well as an increase in HrQoL (from 74.94, SD 15.93 to 80.67, SD 14.46), and emotional scale (from 79.41, SD 15.07 to 82.35, SD 13.53). Lastly, we found statistically significant increases in growth rate on the child’s short stature on the family’s section of the QoLISSY (from 68.45, SD 18.94 to 77.72, SD 18.20) and treatment adherence (from 80.27, SD 4.77 to 88.98, SD 9.84).

    Our findings show that at baseline, 21.56% (n=11) of caregivers reported depression symptoms, categorized as mild (11.76%, n=6), moderate (7.84%, n=4), and extremely severe (1.96%, n=1). Post intervention, depression was reduced to only severe (1.96%, n=1). Anxiety levels at baseline were mild (7.84%, n=4), moderate (13.73%, n=7), and severe (1.96%, n=1) for 23.53% (n=12) of caregivers. After the intervention, 11.76% (n=6) of caregivers reported mild (5.88%, n=3) or moderate (5.88%, n=3) anxiety levels. Stress symptoms also improved; initially, 23.5% (n=12) reported mild (7.84%, n=4), moderate (13.72%, n=7), and severe (1.96%, n=1) stress. Following the intervention, stress symptoms reduced to 7.84% (n=4), with only mild (5.88%, n=3) and severe (1.96%, n=1) symptoms remaining.

    Limitations

    This is a local study conducted in Zaragoza (Spain) with a small sample and no comparison arm. Because of inclusion/exclusion criteria, people with low digital literacy were not able to participate. Although the general prevalence of GHD is higher in boys, most caregivers participating in this study had daughters who have GHD; thus, parents of boys with GHD might have been underrepresented.

    Comparison With Prior Work

    The findings from this study align with and extend previous research on digital interventions aimed at supporting family caregivers of children undergoing GHt. Prior studies have highlighted the significant burden on family caregivers managing GHt, including the physical, emotional, and psychological stress that can negatively impact treatment adherence and the overall health of the child [13]. The ACDP demonstrates notable advancements in this area by providing a comprehensive digital health intervention that effectively supports both the physical and mental well-being of caregivers [33].

    Previous research by Arriba et al [34] suggested that mobile solutions could potentially improve GHt adherence by addressing the emotional states of parents and caregivers. Our study, albeit observational, provides further evidence that digital tools appear to significantly enhance adherence rates by improving caregivers’ psychological states. In particular, our study revealed a statistically significant increase in treatment adherence from baseline (below 85%) to postintervention levels, with 75% of families reaching optimal adherence.

    Furthermore, the mental well-being of caregivers showed substantial improvement, a finding consistent with earlier work by de Arriba et al [34], which highlighted the positive impact of the ACDP on caregivers’ mental health. Our findings show that at baseline, 21.56% (n=11) of caregivers reported depression symptoms, categorized as mild (11.76%, n=6), moderate (7.84%, n=4), and extremely severe (1.96%, n=1). Anxiety and stress levels also showed marked reductions, aligning with the findings from the study by Cervera-Torres et al [22], which emphasized the importance of digital health support for emotional and self-management needs.

    Moreover, our study’s comprehensive assessment of quality of life and well-being metrics—using tools such as the PANAS, MHC-SF, and KIDSCREEN-10—demonstrated significant improvements in cognitive symptoms, mood, emotional and social well-being, and general health. These results further extend the insights from the study by Savage et al [13], which discussed the transformative potential of patient-generated data in integrated care models for GHt. The significant increases in positive affect, general well-being, social well-being, and self-efficacy among participants underscore the holistic benefits of digital health interventions.

    Conclusions

    In conclusion, the ACDP showed favorable acceptance for family caregivers of children undergoing GHt. It is a promising tool and has been demonstrated to add value to the patient and caregiver journey by improving GHD management while supporting the overall well-being of family caregivers. It has helped parents improve their mental well-being as well as treatment adherence. This study provides insights into how digital interventions can better support families of children undergoing GHt.

    Acknowledgments

    This investigator-initiated study was financially supported by Merck Healthcare KGaA, Darmstadt, Germany (CrossRef Funder ID 10.13039/100009945). Merck Healthcare KGaA reviewed the manuscript for medical accuracy only before its submission. The authors are fully responsible for the content of this manuscript, and the views and opinions described in the publication reflect solely those of the authors.

    Conflicts of Interest

    This study describes a digital solution commercialized by Adhera Health. Adhera Health and AdAM have collaborations with Merck Healthcare KGaA beyond this study. SQP, IB, AX-P, RCB and LF-L are employees of Adhera Health. JN is former employee of Adhera Health.

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    ‎
    ACDP: Adhera Caring Digital Program
    DASS-21: Depression Anxiety and Stress Scale-21
    DH: digital health
    GH: growth hormone
    GHD: growth hormone deficiency
    GHt: growth hormone therapy
    GSES: Generalized Self-Efficacy Scale
    HrQoL: health-related quality of life
    ISO: International Organization for Standardization
    MHC-SF: Mental Health Continuum Short Form
    PANAS: Positive and Negative Affect Schedule
    QoLISSY: Quality of Life in short stature youths
    ΔHSDS: change in height standard deviation score

    Edited by Sherif Badawy; submitted 02.Oct.2024; peer-reviewed by Jorge Cancela; final revised version received 14.Jul.2025; accepted 17.Aug.2025; published 27.Oct.2025.

    Copyright

    © Antonio de Arriba Muñoz, Amalia M García-Durán, Patricia Sanz-Aznar, Silvia Quer-Palomas, Ioannis Bilionis, Alba Xifra-Porxas, Joia Nuñez, Ricardo C Berrios, Luis Fernández-Luque. Originally published in JMIR Pediatrics and Parenting (https://pediatrics.jmir.org), 27.Oct.2025.

    This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Pediatrics and Parenting, is properly cited. The complete bibliographic information, a link to the original publication on https://pediatrics.jmir.org, as well as this copyright and license information must be included.