The aim of the proposed randomized controlled trial (RCT) is to determine the effectiveness, and related healthcare costs of a mHealth-based targeted clinical monitoring pathway in GUCH patients. The primary research question is to assess the effect…
ID
Source
Brief title
Condition
- Congenital cardiac disorders
- Cardiac and vascular disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary research question is to assess the effect of mHealth-based
monitoring on the number of contact moments with the hospital (i.e. contact
with the outpatient clinic (visits and telephone consults), visits to the
emergency department, and hospitalizations), in comparison with the control
group.
Secondary outcome
Secondary research questions are superiority of health-related quality of life,
as measured with the EuroQol-5D-5L, SF-36 and PAM-13 using the mHealth
intervention in comparison with the control group and the number of contact
moments, outpatient clinic visits, ER visits and emergency admissions. Research
questions on cost effectiveness are whether a mHealth-based monitoring pathway
leads to cost reduction through change in the number of contact moments with
the hospital (i.e. contact with the outpatient clinic (visits and telephone
consults), visits to the emergency department, and hospitalizations), in
comparison with the control group.
Background summary
mHealth, the provision of targeted medical care through mobile technologies, is
expected to drastically change traditional health structures and is reputed to
be cost-effective. The growing and aging congenital heart disease (CHD)
population, seems especially prone to benefit from mHealth, as they are young
and lifelong affected by their heart disease. So far, there is little evidence
on the effectiveness of mHealth in GUCH patients, and only minor pilot data in
patients with other chronic diseases are available. This lack of evidence,
particularly in the GUCH population, is the reason for our current proposal for
a first research on clinical- and costeffectiveness of mHealth telemonitoring.
Study objective
The aim of the proposed randomized controlled trial (RCT) is to determine the
effectiveness, and related healthcare costs of a mHealth-based targeted
clinical monitoring pathway in GUCH patients. The primary research question is
to assess the effect of mHealth-based monitoring on the number of contact
moments with the hospital (i.e. contact with the outpatient clinic (visits and
telephone consults), visits to the emergency department, and hospitalizations),
in comparison with the control group. Secondary research questions are
superiority of health-related quality of life, as measured with the
EuroQol-5D-5L, SF-36 and PAM-13 using the mHealth intervention in comparison
with the control group and the number of contact moments, outpatient clinic
visits, ER visits and emergency admissions. Research questions on cost
effectiveness are whether a mHealth-based monitoring pathway leads to cost
reduction through change in the number of contact moments with the hospital
(i.e. contact with the outpatient clinic (visits and telephone consults),
visits to the emergency department, and hospitalizations), in comparison with
the control group.
Study design
The proposed study is a multi-centre, parallel, two-groups, open, randomized
controlled trial in symptomatic (e.g. cardiac arrhythmias, congestive heart
failure) GUCH patients.
Intervention
Patients in the intervention group will be monitored for 24 months. The mHealth
telemonitoring program will be used in addition to usual care. The mHealth
telemonitoring program will monitor body weight, blood pressure, heart rate and
single lead EKG. Patients in the intervention group will receive three wireless
devices at home to perform measurements. The results of the measurements can be
sent through smartphone applications or via computer (website). Patients are
expected to perform weight, blood pressure and heart rate measurements twice
every week on weekdays. Once every month patients are expected to perform a
single lead EKG. The research fellow will contact the patients to assist the
patient with installing the devices and performing the first measurements.
Patients can perform extra measurements in case of symptoms. Measurements will
be analyzed daily by the research fellow. Patients will be contacted in case of
multiple threshold exceeding measurements. The treating physician will be
consulted if needed.
Study burden and risks
Patients are expected to perform weight, blood pressure and heart rate
measurements twice every week on weekdays. Once every month patients are
expected to perform a single lead EKG. Patients are requested to fill in
quality of life questionnaires every three months. The risk is negligible.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
> 18 years
Congenital heart disease patient
Symptomatic in the last 1 year: Heart failure NYHA class * II, palpitations or
arrhythmias, hypertension.
Patients with a genetic abnormality resulting in an altered cardiac anatomy or
function.
Exclusion criteria
Unable to give informed consent
Tremor
Not in possession of smart phone or personal computer
Design
Recruitment
Medical products/devices used
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 | NL68384.018.18 |
| OMON | NL-OMON27137 |