The Sugarsquare study: protocol of a multicenter randomized controlled trial concerning a web-based patient portal for parents of a child with type 1 diabetes

Type 1 diabetes (T1D) is a chronic metabolic disorder due to carbohydrate malfunctioning. The incidence of T1D in children is increasing in Europe, with incidence rates expected to raise by 100% in children aged 0 to 5 and by 70% in children aged 0 to 15 in the period from 2005 to 2020 [1]. In 2011, 17.800 new cases of T1D were diagnosed in Europe, increasing the number of children with T1D to 115.700, which makes it the region with the highest rates of children with T1D [2].

T1D comes with a complicated and intrusive treatment regime [3, 4]. Parents have to adapt their child’s lifestyle and their own to the demands of the disease, without withholding their child from typical life experiences [5, 6]. As such, raising a child with T1D can have great impact on parents’ wellbeing [6, 7]. Especially parents of young children with diabetes can show elevated levels of stress, anxiety and depressed mood [8, 9], which can lead to an increase in conflicts within the family, and depressed mood and poor self management skills in the child [7, 9‐11].

Given the impact of the disease and its disease self management, support provided by healthcare professionals is of great importance [4, 12, 13]. Several aspects in pediatric diabetes care show promising results when it comes to supporting parents. A first important factor is education which, defined as providing knowledge and skills needed to perform diabetes self-care, manage crises and make lifestyle changes[12, 13], was found to improve quality of disease management and treatment adherence by child and parents [14‐17] and to subsequently improve the child’s glycemic control [16, 18].

Easy accessible communication with healthcare professionals is a second important factor in diabetes care [19, 20]. Tailored and supportive patient-professional communication was found to be associated with improved disease knowledge and quality of disease management of parents, including treatment adherence [20‐22]. Literature further points out that parents and patients prefer their healthcare professional to find a balance between exchanging technical information and providing emotional support [20, 23].

A third important factor is peer-support, which was found to reduce parenting stress in parents of chronically ill children [24, 25] and to reduce the number of parent–child conflicts concerning diabetes in families of a child with T1D [15]. Peer support is also related to better coping in parents of a chronically ill child [25, 26]. It is suggested that healthcare professionals should be actively involved in organizing peer contact [15, 27], for example by facilitating peer support groups [15] or by appointing mentor-peers [24].

These findings have major implications for healthcare professionals of the diabetes care teams. They are expected to provide tailored disease knowledge, be accessible to patients and facilitate peer support. The internet can be of great assistance to them in facilitating the abovementioned factors [25, 28, 29]. The role of internet in everyday life has increased significantly during the last decade [27]. Especially pediatric patients who need chronic care and their caregivers are expected to benefit from the potential of the internet, as it can be effectively used for exchange of information and knowledge and lower the threshold for communication with healthcare professionals or peers [29‐32]. It is further noteworthy that adolescents with diabetes, parents and healthcare professionals generally support the idea of using internet interventions in pediatric diabetes care [17, 33, 34].

More research is needed, however, on efficacy and feasibility of internet interventions in pediatric diabetes care and especially concerning interventions that combine multiple aspects of care, such as education, patient-professional communication and peer support [30‐32, 35].

In the present paper the background, rationale and design of a patient-initiated, multicenter study are described. In the study, a secured web-based patient portal, called Sugarsquare, is developed and evaluated in terms of efficacy and feasibility. The portal integrates the appealing aspect of using internet with providing tailored disease knowledge, easily accessible communication with healthcare professionals of the diabetes team and peer support in a population of parents of a child with T1D.

Hypotheses:

This paper describes the protocol for a multicenter randomized controlled trial, by which the efficacy and feasibility of a web-based patient portal will be evaluated, in a population of parents of a child with T1D. The web-based patient portal, called Sugarsquare, integrates the appealing aspect of using internet with providing education, easy accessible contact with the diabetes team, and peer support. We hypothesize that the intervention will decrease parenting stress in parents of a child with T1D and will be feasible in the research population.

Sugarsquare provides patients and healthcare professionals with an innovative and easy-accessible tool. Sugarsquare is expected to support parents in coping with and learning about diabetes through exchange of experiences and ideas with peers and to ease communication between parents and healthcare professionals. It is also expected to be feasible as it contributes to the multidisciplinary character of diabetes care by making all communication between healthcare professionals and parents visible for and accessible to all involved healthcare professionals. Combining those aspects in one intervention is an important strength of our study. A second strength of this study is that it incorporates patient participation in the development of the intervention. By exploring needs and wishes of the users and by extensive piloting of the intervention, we were able to fine-tune the intervention to users’ preferences [17, 52]. This will contribute to usability of the intervention and to its generalizability when implementing the intervention in daily care. A third strength of this study is the design of the feasibility assessment using domains proposed by Bowen [51]. This design will enable us to link usage of different sections or applications in the intervention to change in different domains. This design is, on the other hand, also a vulnerability. A design using one arm for every section or application would make it easier to assess the separate contribution of individual sections or applications. However, a web-based patient portal such as Sugarsquare highly depends on the number of users [31]. In the Netherlands, Diabetes care is organized locally, resulting in a great number of diabetes teams with relatively small populations. To get enough users in the intervention group, we could only take on two arms in the present study: 1) an experimental arm and 2) a control arm. Another vulnerability is the chance for drop-out. Studies on internet-delivered interventions often suffer from high drop-out rates, which can significantly interfere with finding potential efficacy of the intervention [28]. To minimize interference, we took a drop-out rate of 25% into account in the sample size calculation. However, we can still be confronted with problems regarding power in the intention-to-treat analysis.

In conclusion, a significant portion of parents of a child with T1D report high levels of parenting stress. Disease education, easy accessible communication with the diabetes care team and peer support help in reducing stress. Although these modes of support are suitable for delivery through the internet, effects of web-based delivery of these aspects in pediatric diabetes care are hardly described in literature. The present study aims to contribute to the knowledge on effects of a web-based patient portal on parenting stress and its feasibility in a population of parents of a child with T1D. Depending on its efficacy and feasibility, the intervention will be attuned in light of results of the study and additionally be implemented in usual pediatric diabetes care.

CV, PhD, is a clinical psychologist and section leader of patient care section for the Department of Medical Psychology of the Radboud university medical center. Professor CN MD, PhD, is head of the Department of Pediatrics of the Radboud university medical center and medical director of the Children’s Diabetes Center. EB, MSc, is a PhD-student at the Department of Medical Psychology of the Radboud university medical center.