Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02869958 |
| Other study ID # |
P140316 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 3, 2016 |
| Est. completion date |
April 29, 2020 |
Study information
| Verified date |
December 2020 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
It is recommended that patients with asthma owned a written action plan which must include
the names, doses and dosing of the treatment they should take when acute respiratory symptoms
occur.
Current written action plans must be short to be readily used (1 page) and, therefore, cannot
fit all acute situations. Moreover, they may not be available where and when required.
The investigators sought that a digital action plan, available through Smartphone or tablet
computer connected to the internet, could adequately provide suitable action plans according
to the severity of the described exacerbation, and would be more easily available when
useful.
The aim of the study is to study the effect of the use of a digital action plan for asthma
exacerbation, on the frequency of unscheduled medical contacts (phone calls, visits to
physicians or to emergency departments, hospitalizations) in children and in adults with
asthma. The investigators hypothesized that the use of the digital action plan could reduce
avoidable unscheduled visits due to mild or moderate exacerbations that could successfully be
managed by the patient or his/her caregivers.
Description:
Asthma is a frequent chronic disease (10% prevalence in children and 7% in adults) during
which acute exacerbations can occur that require adequate treatment, usually by the patients
and/or his/her caregivers. Despite action plan for asthma exacerbation being recommended by
national and international guidelines, urgent medical contact and often Emergency Department
visits remain frequent for asthma exacerbation.
Reasons for medical contact may be related to the inefficiency of the current Written Action
Plan because of its stereotyped advice whatever the level of severity of the exacerbation,
and because the patients might not have the paper with him/her where and when he/she needs
it.
The investigators sought that new electronic technologies could solve these issues of
inadequacy of content and availability of the Written Action Plan.
A program was built to provide sets of advices according to the severity of the exacerbation
described by the patient using simple clinical descriptors included in the Global Initiative
for Asthma (GINA), and weighted by the medication already used for the exacerbation. In this
way the investigators feel that patients could be more confident in the appropriate treatment
proposed by the algorithm. Second, the possibility to connect through portable electronic
devices (Smartphone, tablet computer) make the action readily available as far as an internet
connection is possible.
The Digital Action Plan is designed to treat asthma exacerbations of all levels of severity
and advice to visit a doctor within few days or to go at once to an emergency department as
appropriate as by the situation based on the patients' information. The investigators
designed a randomized study to assess the effect of the Digital Action Plan on unscheduled
urgent medical contacts (phone calls, visits to physicians or to emergency departments,
hospitalizations) in children and in adults with asthma.
Methodology of the study A multicenter, controlled, randomized, open study, comparative on 2
parallel groups recruited in private practice and in hospitals within or outside the APHP
consortium.
Both arms have the Written Action Plan respecting the current recommendations; the
experimental arm has in addition the possibility to connect to the AppWeb to obtain advices
from the Digital Action Plan.
The investigators hypothesized that the use of the digital action plan could reduce avoidable
unscheduled visits due to mild or moderate exacerbations that could successfully be managed
by the patient or his/her caregivers. In the long run, this kind of program could also become
a tool for telemedicine Statistical analysis : about 80% of children and adult patients
included will have a exacerbation during the follow-up year. The expected effect of the
Digital Action Plan is a 20% (relative variation) decrease of the main outcome : in Written
Action Plan group, frequency = 0.8, in Digital Action Plan group, frequency = 0.64 (20% i.e.
0.16 reduction of frequency). Moreover, the Written Action Plan has been shown to result in a
25% decrease of unscheduled visits for severe exacerbation (4); we therefore hypothesize that
the supplemental reduction in unscheduled visits induced by the Digital Action Plan will be
smaller than that of Written Action Plan despite the recording of moderate exacerbations in
addition to severe exacerbations. . With this features, samples of N= 121 per group are
necessary (80% power, bilateral alpha risk of 5%). With an expected attrition of about 15%, a
total of 280 patients will be included. This target can be achieved with regard to the
activity of participating centers.
Number of participating centers = 43
