|- candidate number||28358|
|- NTR Number||NTR6909|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-dec-2017|
|- Secondary IDs||METC 2017-0089 MaastrichtUMC|
|- Public Title||Evaluation of Effect of the Online Accessible 360°CHILD-profile on Satisfaction of Parents and Youth About Health Service Accessibility of the Preventive Child and Youth Health Care|
|- Scientific Title||Doorontwikkeling Van Het 360°CHILDoc Tot Een Digitaal Beschikbaar Kind-profiel Met Evaluatie Van de Bijdrage Aan Het Succes Van Hulp Binnen de Zorg Voor Jeugd en Implementatieonderzoek|
|- ACRONYM||Online 360°CHILD-profile |
|- hypothesis||By making a child-profile (360°CHILDoc) online available for parents and youth, they will be more satisfied about the health service Accessibility of the Preventive Child and Youth Health Care (CYHC) and the integral CYHC- information about child and environment on the profile will be used more in Care of Youth. |
|- Healt Condition(s) or Problem(s) studied||Functioning of children, Development of children|
|- Inclusion criteria||Randomisation units are children between 2 and 16 years old living in Southern of Limburg of the Netherlands, that experience problems in health and development which requires action and/or follow up by the CYHC and contact with other caregivers. |
Study population includes parents of randomisation units (children) and/or the children themselves if age 12-14 and the involved caregivers.
|- Exclusion criteria||Parents, youth and caregivers that have no access to or can not handle a computer and/or internet and/or already participated in previous pilots of the 360°CHILDoc.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2018|
|- planned closingdate||1-mrt-2020|
|- Target number of participants||64|
|- Interventions||Intervention: Online accessible 360CHILDoc available during a period of 6 month |
Control group: care as usual by CYHC
|- Primary outcome||Satisfaction of parents, youth and caregivers about the health service Accessibility of the Preventive Child and Youth Health Care (CYHC)
|- Secondary outcome||The frequency in which the integral information, collected by the CYHC, is seen by parents and used by parents during contact with other care givers in Care of Youth. |
|- Timepoints||Outcome measurement at the end of intervention period (6 months after inclusion)|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Miriam Weijers|
|- CONTACT for SCIENTIFIC QUERIES|| Miriam Weijers|
|- Sponsor/Initiator ||Maastricht University Medical Center (MUMC+), GGD Zuid Limburg|
(Source(s) of Monetary or Material Support)
|ZonMw, GGD Zuid Limburg|
|- Brief summary||Country of recruitment: the Netherlands|
A 360⁰Child-profile, with theoretically ordered, integral child-information visualized in one image, is designed by the Dutch preventive Child and Youth Health Care (CYHC). The introduction of this new data/information carrier gives an important incentive to enhance a transformation towards personalized health care for children and adolescents by supporting the complex medical thought process of CYHC-medical doctors (MD’s). This information tool aims to effectively estimate child’s functioning, detect emerging health problems and inform parents and caregivers.
This trial is part of an iterative development process, parallel with Participatory Action Research with a mixed methods design.
After the development of an online version of the 360⁰Child-profile, CYHC professionals (n=18) will recruit in total 64 children between 2 and 16 years (randomisation units). Children can be included if they experience health- and/or development problems that require action an/or follow up by the CYHC and contact with other caregivers.
After enrolment and informed consent by parents and youth, basic characteristics will be measured and the children will be assigned to the intervention- or control group by the secretary of Maastricht University. For randomisation a predesigned, computer generated block randomisation scheme is used, with blocks of 6 units.
During a period of 6 months, an online 360⁰Child-profile will be available for parents and youth in the intervention group to check the profile whenever they want and use it in contact with other caregivers. The control group receives care as usual with no 360⁰Child-profile available.
After the intervention period the parents of all children, the children themselves (if age 12-16) and the caregivers involved, will be asked to fill in a questionnaire. Questions with answer options on a Likert scale will be used to measure the satisfaction about the health service accessibility of the Preventive Child and Youth Health Care.
During the intervention period the frequency in which the integral information on the child-profile is seen by parents and used during contact with other caregivers, will be registered in the 360⁰Child-profile application and the electronic medical dossier of the CYHC.
Data from the questionnaires and registrations will be analysed by “linear mixed models” so both “fixed effects” as “random effects” can be included.
Factors like education level and origins of parents and child’s age and level of experienced problems will included in the model as co-variates.
The results will show if and in what extend there are differences in satisfaction about CYHC accessibility and frequency of usage of CYHC integral information about a child between intervention- and control group. This trial will obtain the first results about effectiveness of the 360⁰Child-profile and will be followed by further research; firstly further exploration of the obtained quantitative results by qualitative research.
|- Main changes (audit trail)|
|- RECORD||19-dec-2017 - 4-jan-2018|