General- To compare physical activity levels of pediatric patient subjects with healthy control subjects.- To compare mean heart rate and variation in heart rate during the day of patients and healthy controls.- To compare sleep duration of patients…
ID
Source
Brief title
Condition
- Other condition
- Blood and lymphatic system disorders congenital
- Bronchial disorders (excl neoplasms)
Synonym
Health condition
obesity, chronic fatigue
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Daily physical activity level (step count)
Secondary outcome
Baseline information
Baseline questionnaires:
Arm A: Pediatric Quality of Life Inventory (PedsQL) 4.0, pedsQL
multidimensional fatigue scale, Pediatric Functional Assessment of Chronic
Illness Therapy-Fatigue (peds-FACIT-F), Revised Children*s Anxiety and
Depression Scale (RCADS), Children's Somatization Inventory (CSI), PROMIS
pediatric pain
Arm B: pedsQL 4.0, CSI, RCADS
Arm C: pedsQL 4.0, pedsQL pain quality, PROMIS Pediatric pain,
Arm D: pedsQL 4.0, modified standardized pediatric asthma quality of life
questionnaire (MPAQLQ(S)), modified asthma control questionnaire (MACQ), cystic
fibrosis questionnaire (CFQ), respiratory symptom scores
Sleep:
Hours of sleep, time deep sleep, time shallow sleep
Heart rate:
Mean heart rate, max heart rate, min heart rate
Weight and body composition (bioimpedance analysis):
Arm A: baseline and end-of-study weight and body composition
Arm B: weekly weight and body composition
Symptom scores via smartphone app:
Arm A: Daily: fatigue score, sleep quality score, self-reported activity score,
parent reported activity score, screen time score. Weekly: peds-FACIT-F, PROMIS
Pediatric pain
Arm B: Daily: self-reported activity score, parent-reported activity score,
screen time score, sleep quality score
Arm C: Daily: pain intensity score, pain limits activity score, number of
painful areas, parent-reported activity score, self-reported activity score,
screen time score, sleep quality score. Weekly: PROMIS Pediatric pain
Arm D: Daily: asthma control diary (subjects with asthma only), respiratory
symptom scores (subjects with cystic fibrosis only), parent-reported activity,
self-reported activity, screen time score, sleep quality score
Daily environmental data:
Arm C: local air quality (NO2, NO, O3, PM10, PM2.5), weather conditions (mean
temperature, max temperature, min temperature, mean wind speed, mean air
humidity, sun exposure duration, amount of rain)
Arm D: local air quality, pollen count, weather conditions
Lung function:
Arm C: baseline and end-of-study NuvoAir spirometry (FEV1, FVC, FEV1/FVC, PEF)
Arm D: baseline hospital spirometry, baseline and daily home NuvoAir spirometry
(FEV1, FVC, FEV1/FVC, PEF)
Blood pressure:
Arm A: daily blood pressure measurements
Arm B: daily blood pressure measurements
Compliance:
Proportion of patients with > 70% compliance to study tasks
Unplanned visits or admissions during study period
Labs or diagnostic procedures, obtained as part of standard of care if deemed
necessary by treating physician, for example:
Arm A: complete blood count, thyroid screening, C-reactive protein
Arm B: DEXA-scan, thyroid screening
Arm C: hemoglobin, leukocytes, irreversibly sickled cells, reticulocytes
Leftover blood samples will be stored
End-of-study questionnaires:
General: questionnaire for parents and children about the experience and
tolerability of the methods of data collection.
Arm A: pedsQL 4.0, peds-FACIT-F, pedsQL multidimensional fatigue scale, RCADS,
CSI
Arm B: pedsQL 4.0, RCADS, CSI
Arm C: pedsQL 4.0, pedsQL pain quality, PROMIS Pediatric pain
Arm D: pedsQL 4.0, asthma control questionnaire (subjects with asthma only),
cystic fibrosis questionnaire (subjects with cystic fibrosis only)
Background summary
Treatment, follow-up and execution of clinical trials of children with chronic
disease is challenging. Often, there is a considerable time interval between
outpatient clinic visits and patients* and parents* ability to recall the
severity of symptoms is often suboptimal and subjective. Furthermore, clinical
trials are often quite invasive and time-consuming for children. One option to
overcome these problems is frequent, non-invasive monitoring of symptoms and
disease activity. An example of non-invasive monitoring is by using smartwatch
technology. Recent systematic reviews have reported studies that used a
smartwatch to measure activity level, eating behavior and seizures, among other
things. It has been hypothesized that these devices can also be used to monitor
various other conditions. However, past studies are almost always performed on
adults and usually in a lab setting. This way of collecting data thus seems to
warrant further validation among children at home.
CHDR has developed a home-monitoring platform that comprises of several
devices, one of which is the Nokia Steel HR. This wearable device can monitor
physical activity levels, measure pulse rate and analyze sleep pattern and
sleep duration. Furthermore, with the NuvoAir spirometer, subjects can collect
full spirometry data with their smartphone. Several other devices, like the
Nokia Body+ Scales, Nokia Blood Pressure Monitor, are also part of the
platform.
In the future, home-monitoring research, aimed at quantifying disease-activity,
will be performed at the Juliana Children*s Hospital in the Hague. This study
aims to evaluate the feasibility of home-monitoring in patients with fatigue
(arm A), obesity (arm B), sickle cell disease (arm C) and chronic lung disease
(arm D). Furthermore, it aims to compare activity levels of patients to healthy
controls and to evaluate correlations between physical activity, heart rate,
environmental factors and symptoms.
Study objective
General
- To compare physical activity levels of pediatric patient subjects with
healthy control subjects.
- To compare mean heart rate and variation in heart rate during the day of
patients and healthy controls.
- To compare sleep duration of patients and healthy controls
- To evaluate adherence to study tasks in pediatric subjects
- To determine the tolerability, feasibility, quality and quantity (wear time)
of the employed methods of data collection in different age groups.
- To evaluate the ePro questionnaire and notifications app.
Arm A, patients with fatigue.
- To identify factors in the collected data (physical activity, heart rate),
the patients* medical history, physical examination or demographics that
correlate with the presence of physical illness.
- To compare daily blood pressure measurements of pediatric fatigue patients to
healthy controls
Arm B, patients with obesity.
- To identify a correlation between physical activity and weight loss or weight
gain during the study period.
- To compare daily blood pressure measurements of pediatric obesity patients to
healthy controls
Arm C, patients with sickle cell disease.
- To find correlations between the presence of symptoms, obtained via
questionnaire data, and collected data (mean heart rate, physical activity,
sleep duration).
- To find correlations between the presence of symptoms and air quality and
weather conditions.
- To evaluate correlations between physical activity and impaired lung function
- To gather data regarding physical activity and heart rate before, during and
after a vaso-occlusive crisis, if such an event occurs during the study period.
- To validate the NuvoAir spirometer in pediatric patients
Arm D, patients with chronic lung disease.
- To evaluate the tolerability, compliance and intrasubject variability of
daily lung function monitoring.
- To assess correlations between the presence of symptoms and asthma control
and collected data (mean heart rate, physical activity, lung function, sleep
duration, pollen counts, air quality, weather conditions).
- To gather data regarding physical activity, heart rate and lung function
before, during and after an asthma exacerbation or pulmonary cystic fibrosis
exacerbation, if such an event occurs during the study period.
- To validate the NuvoAir spirometer in pediatric patients
Study design
Prospective observational case-control study to monitor symptoms and behavior
in pediatric patients with different chronic diseases in a home-setting.
Study burden and risks
The burden for study participants is estimated to be low and consists of
several baseline study assessments, the continuous wearing of the Nokia Steel
HR watch, daily spirometry or blood pressure measurements, weekly weighing, and
daily or weekly questionnaire assessments for the duration of the study period.
The assessments have been designed to be as unobtrusive as possible and are
outlined in tables 1-4. No invasive procedures are included in this study.
There are no significant health risks associated with the study assessments.
Furthermore, we do not expect any risks regarding the psychological or social
state of study participants. Except for the smartwatch assessments, for which
data will be collected continuously, all study mandated actions can be
performed at the subjects* home or at the outpatient clinic. Collected digital
data will pass through adequately protected data servers, which will prevent
privacy infractions. Furthermore, the study assessments will not be used to
influence the clinical decision process.
The proposed study can only be performed in this group of paediatric patients
as described above. Performing this study in an adult population would yield
major difficulties since disease behaviour in adult patients is significantly
different when compared to children.
Zernikedreef 8
Leiden 2333CL
NL
Zernikedreef 8
Leiden 2333CL
NL
Listed location countries
Age
Inclusion criteria
General
1. Signed informed consent from both parents or the legal guardian prior to any
study-mandated procedure and from subjects aged older than 11 years old.
2. Patients undergoing treatment by a pediatrician
3. Age 6-16 years for subjects in arm A, B and D. Age 5-17 for subjects in arm
C., Arm A.
- Patients are referred by their general practitioner due to complaints of
general malaise, fatigue or tiredness.
Arm B.
- Patients are diagnosed with obesity
Arm C.
- Patients are diagnosed with sickle cell disease
Arm D.
- Patients are treated for cystic fibrosis or
- Patients have controlled or difficult to control asthma at the time of
inclusion.
o Difficult to control asthma defined by Asthma Control Questionnaire cutoff
score of 1.5 or
fulfilling * 3 Global Initiative for Asthma (GINA) criteria for
partly/uncontrolled asthma
Exclusion criteria
1. Evidence or history of lung disease, cardiac disease, neuromuscular disease,
diabetes (excluding: CF-associated diabetes in arm D, diabetes type 2
associated with obesity in arm B) or any other chronic condition other than the
studied disease, that might impair activity level.
2. Children that have a mental and/or motor impairment.
3. Inability to wear or use the wearable device.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL66457.098.18 |