The aim of this study is to determine whether this smart wristband can actually support patients and their parents in managing the consequences of hypothalamic dysfunction. We will investigate what kind of support patients, parents, or caregivers…
ID
Source
Brief title
Condition
- Hypothalamus and pituitary gland disorders
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome parameter of this study is the score on a 5-point Likert
scale as answer to the question posed in the PREM questionnaire at T2:
"The use of the EndoWatch has supported me in the management of the
consequences of hypothalamic dysfunction" (for participant) OR
"The use of the EndoWatch has supported me in the management of the
consequences of hypothalamic dysfunction of my child" (for parent)
Secondary outcome
Secondary outcome parameters of this study are:
1. Management of hypothalamic dysfunction assessed per domain:
A. Management of temperature dysregulation:
- Score on a 5-point Likert scale in the PREM questionnaire, answered at T2, to
the questions in the section 'Managing Body Temperature'.
- Difference in average delta of wrist temperature per day (* = maximum_temp -
minimum_temp) measured by the EndoWatch, between the first and last 4 weeks of
the study.
B. Management of sleep problems:
- Score on a 5-point Likert scale in the PREM questionnaire, answered at T2, to
the questions in the section 'Managing Sleep'.
- Intraindividual changes of total scores measured by PROMIS Sleep Disturbances
Short Form (Appendix C) between T0 - T1 - T2.
- Intraindividual changes of scores measured by PROMIS Sleep Related Impairment
Short Form (Appendix D) between T0 - T1 - T2.
C. Management of daily activity:
- Score on a 5-point Likert scale in the PREM questionnaire, answered at T2, to
the questions in the section 'Managing daily activity'.
- Difference between average number of steps per day measured by EndoWatch of
the first 4 weeks compared to average number of steps per day measured by
EndoWatch of the last 4 weeks of the study.
D. Management of hypocortisolism during episodes of increased physical or
emotional stress:
- Score on a 5-point Likert scale in the PREM questionnaire, answered at T2, to
the questions in the section 'Managing stress or illness'.
E. Management of AVP deficiency:
- Score on a 5-point Likert scale in the PREM questionnaire, answered at T2, to
the questions in the section 'Managing desmopressin use'.
2. Explorative comparison of EndoWatch measurements to current home
measurements of patients with hypothalamic dysfunction, assessed per domain:
A. Comparison of EndoWatch measurement of wrist temperature with current home
measurement of temperature:
- Difference between EndoWatch measurements of wrist temperature to
self-measured ear or rectal thermometer (3 times a day & if otherwise
necessary) during two 7-day periods.
B. Comparison of EndoWatch measurement of sleep with self-reported sleep- and
wake times:
- Difference between EndoWatch measurements of sleep-onset and -wake times and
self-reported sleep-onset and -wake times in the sleep diary, based on two
7-day periods.
C. Comparison of EndoWatch measurements of steps per day with current home
measurement of steps per day by smartwatch:
- Difference between EndoWatch measurement of steps per day and the current
home measurement of steps per day that was measured by smartwatch, based on two
7-day periods. (Note: only for patients who are already used to wearing
smartwatch)
D. Comparison of EndoWatch measurement of changes in physiological metrics with
episodes of self-reported increased (physical or emotional) stress:
- Difference in physiological metrics (heart rate (variability), wrist
temperature, skin conductance) during self-reported episodes of increased
(physical or emotional) stress (in diary) and during episodes without increased
stress, i.e. stress vs non-stress episodes.
3. Required improvements for further development of the EndoWatch, as reported
by patients and/or caregiver(s) in semi-structured close-out interviews (at T2).
4. Psychosocial impact of the EndoWatch on patients, caregiver(s) and families,
as reported by patients and/or caregiver(s) in semi-structured close-out
interviews (at T2).
Background summary
The hypothalamus is an area in the brain that regulates the *overall bodily
balance.* It controls functions such as body temperature, the biological clock,
hunger and thirst sensations, energy expenditure, behavior, and the regulation
of the pituitary gland (which excretes and controls various hormones in the
body). When the hypothalamus no longer functions properly, one or more of these
tasks may no longer be performed correctly. This is known as hypothalamic
dysfunction. The body is then *out of balance.* This can lead to a variety of
symptoms and result in severe obesity, fatigue, and more. Additionally, it
requires continuous care from the patient, their parents, or caregivers, which
has a significant impact on their daily life.
A smart wristband that continuously monitors body temperature, stress, sleep,
and daily activity in patients with hypothalamic dysfunction could help ease
the burden for parents, caregivers, and healthcare providers. This wristband is
called the EndoWatch. With it, imbalances can be detected and addressed
earlier, and more support can be provided in managing hypothalamic dysfunction.
Parents can act sooner, take appropriate action, and gain more insight into
their child's health (where, in many cases, the child cannot sense or
communicate symptoms). A previous pilot study involving 10 patients with
hypothalamic dysfunction has shown that wearing this wristband is feasible for
both children and adults with hypothalamic dysfunction and that the device and
app are easy to use.
Study objective
The aim of this study is to determine whether this smart wristband can actually
support patients and their parents in managing the consequences of hypothalamic
dysfunction. We will investigate what kind of support patients, parents, or
caregivers experience and what improvements should be made to the wristband. We
also want to understand how the use of this smart wristband affects the
feelings of patients and parents. The results of this study will be used in
further research needed for the further development of this smart wristband, so
that it can ultimately be used in the home setting for patients who might
benefit from it.
Study design
This is a prospective, longitudinal, observational study.
Study burden and risks
As described in more detail in the study summary in the protocol, and in
sections 6.4 and 11.4, the burden of this study is limited to wearing the smart
watch, the extra time it takes for the participant and their parents to
complete the diaries, and the 3 hospital visits required for this study (2 of
which can also take place online if desired).
Some participants may find wearing the smart watch uncomfortable or burdensome,
but wearing the wristband itself poses no (health) risks. If the participant
decides not to wear the smart watch for this reason, they are free to withdraw
from the study.
The ability to access the measurements in the app does not present direct
health risks. This is an exploratory, observational study, and the participants
are not subjected to any interventions nor will they receive separate
instructions based on these measurements. The researchers do acknowledge the
potential risk of additional anxiety or stress as a result of continuous health
monitoring. However, this risk is considered minimal, as previous pilot studies
indicated that many participants reported that the monitoring actually provided
a sense of control and reduced feelings of anxiety.
In conclusion, the burden and risks associated with participation in this study
are both considered to be minimal, and it is considered that this is
proportional to the relevance of the study and the potential benefits for the
participants.
Heidelberglaan 25
Utrecht 3584 CS
NL
Heidelberglaan 25
Utrecht 3584 CS
NL
Listed location countries
Age
Inclusion criteria
- Age (at time of study enrolment) between 6-40 years;
- Diagnosed with hypothalamic dysfunction by an endocrinologist. Hypothalamic
dysfunction is diagnosed as having at least two of the following symptoms:
*having a decreased resting energy expenditure <80%, as measured with
indirect calorimetry OR
*experiencing hyperphagia OR
*overweight or obesity OR
*sleep pattern disturbances OR
*behavioural disorders (defined as presence of obsessive compulsive symptoms,
hoarding and/or periods of rage) OR
*temperature regulation disorder OR
*pituitary dysfunction OR
*AVP deficiency with inadequate thirst regulation
- Informed consent has been received.
Exclusion criteria
- Age (at time of study enrolment) <6 or >40 years
- Patients actively undergoing intensive treatment for (supra)sellar tumor
- Illiteracy in patient or caregiver
- Language barrier, despite involvement of interpreter and translation of
study information.
- Pre-existing skin conditions to the upper extremities, such as psoriasis,
(severe) eczema.
- Informed consent has not been received
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL87495.041.24 |