|- candidate number||13390|
|- NTR Number||NTR3643|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||1-okt-2012|
|- Secondary IDs||36650.091.11 CCMO|
|- Public Title||Sugarsquare: Online treatment environment for parents of a child with Diabetes Mellitus Type 1.|
|- Scientific Title||Sugarsquare: Online treatment environment for parents of a child with Diabetes Mellitus Type 1.|
|- ACRONYM||Sugarsquare for Parents|
|- hypothesis||Use of an online treatment environment will lead to decrease in parenting stress. |
|- Healt Condition(s) or Problem(s) studied||Diabetes Mellitus Type 1 (DM type I)|
|- Inclusion criteria||1. Parent of at least one child with T1DM;|
2. Who is under the age of 13 at start of the study.
|- Exclusion criteria||Parents who are not able to understand Dutch written language.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2012|
|- planned closingdate||1-nov-2013|
|- Target number of participants||240|
|- Interventions||Sugarquare is an online policlinic, on which parents can find a chat application and a forum application for peer contact. Further, parents will find an overview of their child’s treatment on a secured, individual section on which they can discuss their child’s treatment with the treatment team. Parents can further find reliable information on the disease and an overview of ongoing studies and recent study results. Interaction of individual treatment team members with parents will be visible for all other treatment team members.
The control group will start the intervention after 6 months.
|- Primary outcome||Parenting stress (NOSIK; de Brock, Vermulst, Gerris & Abidin, 1992).|
|- Secondary outcome||1. Psychosocial wellbeing of the parent (GHQ; Koeter & Ormel, 1991);|
2. Conflicts within the family, diabetes related (DFCS; Hood, Butler, Anderson & Laffel, 2007);
3. Impact of the disease on the family (PedsQL family impact scale; Varni, 2008);
4. General quality of life (PedsQL generic; Varni, 2003);
5. Health related quality of life (PedsQL Diabetes module; Varni, 2003);
6. Psychosocial well-being of the child (SDQ; van Widenfelt, Goedhart, Treffers & Goodman);
7. Parents’ knowledge on diabetes (DKT; Fitzgerald, 1998);
8. Treatment adherence (MMAS; Morisky, 2008);
9. Convidence in diabetes self-care (CIDS/VDZ; vd Ven, 2008);
10. Patients’ Evaluation of Quality of diabetes care (PEQ-D; Pouwer & Snoek, 2004);
11. Glycemic control of the child (HbA1c);
12. Hospitalization (number of hospital admissions of 24 hours or over in case of glycemic disruptions);
13. All users’ activities on the intervention (treatment team + parents);
14. Parents' consumption of care.
|- Timepoints||T0: Baseline;|
T1: 6 months following baseline (halfway through the trial);
T2: 12 months following baseline (end of the trial).
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MSc. E.A. Boogerd|
|- CONTACT for SCIENTIFIC QUERIES||MSc. E.A. Boogerd|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|Dutch Innovation Funds Healthcare-insurers|
|- Brief summary||Rationale:|
Type 1 Diabetes Mellitus is a chronic metabolic disorder, which demands a complicated disease self-management. This stresses parents and child to adapt their lifestyle to the demands of the disease and is highly dependent on the skills and motivation of the parents and child. To support parents in the disease self-management, a low level, easy approachable way of communication with the treatment team is of great importance. A quick, demand-driven way of working by the treatment is endorsed by parents in this. Peer contact also seems to contribute to parents’ self-management, as well as good alignment of the treatment team. Recent research shows that ICT can play a significant role in facilitating these. In the present study, we will implement an online policlinic aimed at patient-caregiver communication and peer contact in seven centres for paediatric diabetes care.
The primary goal of Sugarsquare is to decrease parenting stress in the parents of children with Type 1 Diabetes Mellitus by supporting them in their disease management. We further aim to decrease problems parents and children perceive in incorporating diabetes self-management in everyday family life, which is expected to improve parents’ and child’s well-being and increase parents’ satisfaction of quality of care. We additionally try to improve alignment of the treatment team. We expect to improve the child’s glycemic control, decrease the number of hospitalizations and to improve contact between parents and treatment teams. We also aim to describe which applications will appeal to parents the most.
We will test effect of the intervention by means of a randomized controlled trial. Participants will randomly be assigned to an experimental group and a control group. The experimental group will use the intervention from the start of the study; the control group will use the intervention from 6 months following the start of the study. Data will be collected by means of questionnaires at start of the study (baseline), halfway the study period (at 6 months following start of the study) and at the end of the study period (at 12 months). Further, participants will weekly answer questions aimed to assess their care consumption of the past week. To lower threshold and to make it as easy as possible for parents to respond, all questionnaires will be send and answered through a secured link on the internet.
The study population consists of parents of children with Type 1 Diabetes Mellitus.
Intervention (if applicable): Sugarquare is an online policlinic, on which parents can find a chat application and a forum application for peer contact. Further, parents will find an overview of their child’s treatment on a secured, individual section on which they can discuss their child’s treatment with the treatment team. Parents can further find reliable information on the disease and an overview of ongoing studies and recent study results. Interaction of individual treatment team members with parents will be visible for all other treatment team members.
Main study parameters/endpoints:
Parenting stress, assessed by means of the Parenting Stress Index Short Form (PSI-SF) is the primary outcome in the present study. Our power calculation is based on this questionnaire.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
This study will be performed using healthy parents of children diagnosed with type 1 diabetes, under the age of 13. Parents are responsible for their child and therefore one the most important actors in the treatment of their child. By intervening in parents, we expect to have significant influence on the child’s treatment. Parents will not have to visit their treatment centre for the study more often than accordingly care as usual. Burden therefore only consists of filling out the questionnaires. Risks are negligible.
|- Main changes (audit trail)|
|- RECORD||1-okt-2012 - 18-okt-2012|