The primary objective is to evaluate the effect of the PAL-system on diabetes self-management determinants and behaviour and as a result on the health of children with T1DM. The PAL-System consist of a robot and a MyPAL-app, containing an avatar of…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The hypothesized main study outcomes are (1) an improvement in the intervention
group in Type 1 Diabetes health outcomes: HbA1c values (measured with a finger
prick) and glucose values (collected by a glucometer, as part of the standard
diabetes management regime) of PAL 3.0 during phase 1. And (2) an improvement
of diabetes knowledge (questionnaire).
Secondary outcome
The hypothesized secondary outcomes during phase 1 are (1) improvements in
Diabetes-related Quality of Life (measured with the PedsQoL-DM questionnaire by
both child and parent(s)), (2) self-management determinants and behaviour
(measured with the Self-Care Inventory, SC, questionnaire and self-management
goal achievement in the PAL-system), and (3) system usability (SUS, only
intervention group).
The expected outcome in phase 2 is a further improvement of the usability and
use of the PAL-System V3.5, with additional features, in comparison to V3.0.
Background summary
The EU H2020 PAL project aims at developing a multi-system technology (i.e. the
PAL-system) that can support young patients with Type 1 Diabetes Mellitus
(T1DM), aged 7 to 14, their families and the medical staff, and accompany them
in a shared educational path towards a proper management of the disease,
possibly having an impact on their diabetes health outcomes and related
knowledge.
Study objective
The primary objective is to evaluate the effect of the PAL-system on diabetes
self-management determinants and behaviour and as a result on the health of
children with T1DM. The PAL-System consist of a robot and a MyPAL-app,
containing an avatar of the robot. Children can play educational activities
with the robot in the hospital and with the avatar at home and have talks about
their day and their diabetes. Also, children can work on personal diabetes
objectives, set together with their health care professional (HCP) and parents.
Parents and HCP can monitor to what extend children achieve their objectives,
through dedicated, secured web pages, part of the PAL-System. HCP can also
tailor through their webpage the content of the activities to offer children
additional support to achieve their objectives.
The secondary objective is to evaluate the usability and use of the system,
both from children*s perspective and their parents and healthcare
professionals.
Study design
The study design will be a randomized controlled trial with a wait-list control
group. The children will be randomly assigned either to an intervention group
(group A) or a control-wait list group (group B). The intervention group will
be accustomed through the use of a first version of PAL (V.3.0) for 3 months.
After 3 months the effectiveness, in terms of T1DM-related indicators, of PAL
3.0 will measured. After a summer break, both groups will be asked to play with
a second version of PAL (V.3.5) for another period of 3 months, after which the
added value of several extended features will be evaluated in regard to their
impact on usability and use of the PAL-system.
Intervention
The children meet the robot in the hospital and play an educational activity.
Also, they set with their HCP and parents personal diabetes self-management
objectives, to work on at home through their MyPAL-app. For example, they want
to sleep over at a friend, which means they need to know how to count carbs and
recognize when they have high and low glucose values. At home, to work on their
objectives, they play educational activities with the avatar (including, quiz,
memory, and sorting game) and conversations about their day (e.g., did they do
sports, how did they feel) and their diabetes (e.g., their most recent glucose
value). After approximately 3 months, they return to the hospital, they play
another activity with the robot and review the objectives with their HCP.
Study burden and risks
Possible burdens: extra hospital visits, extra finger prick HbA1c, use of app
takes time and places emphasis on sickness. We know from the previous
experiments that this works two ways: some children see it as a burden because
it places extra emphasize on their sickness (they want to lead normal lives),
while others (younger/just diagnosed) are more proud of the app/robot and enjoy
playing and learning. Some also see the diary and sorting activity as a burden
because it not user friendly enough.
Schipholweg 77
Leiden 2316 ZL
NL
Schipholweg 77
Leiden 2316 ZL
NL
Listed location countries
Age
Inclusion criteria
- Children should be between 7 and 14 years old
- Diagnosed with type I Diabetes Mellitus (T1DM) - The diagnosis is older than six months
- The child is treated at one of the participating hospitals
- The child and at least one parent have a good command of the Dutch language
- An informed consent form should be signed by the child and both his/her parents
Exclusion criteria
The participant will be excluded if he/she has an co-existing medical condition that, according to the treating physician, is expected to interfere with the study results. For example intellectual disability, autism spectrum disorders, epilepsy and cerebral palsy).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL65421.100.18 |