Effectiveness of a Web-based, Digital Health Platform Combining Social Care and Respiratory Coach Support to Improve Adherence to Treatment and Symptom Control in Children and Adolescents With Difficult-to-control Asthma
A mHealth Intervention to Improve Symptom Control in Children and Adolescents With Difficult-to-control Asthma
Sponsors
Lead Sponsor
Collaborators
Source
Lovexair Foundation
Oversight Info
Has Dmc
Yes
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
Brief Summary
Asthma is the most common chronic respiratory disease worldwide. Despite advances in asthma
management, control of the disease is still a challenge especially among children.
Information and communications technology (ICT) have been recently used in clinical practice
to increase awareness of diseases, encourage patients to engage in the management of their
conditions and improve monitoring and surveillance. The investigators of this study will test
a new digital platform combining online/offline content aimed to improve asthma control and
reduce exacerbations and unnecessary consultations in children with difficult-to-control
asthma. A randomised controlled trial enrolling 60 patients allocated in two groups has been
designed. The intervention group (IG) will be granted free access during 6 months to a
web-based platform. During this period, patient will have access to online/off line content
to improve disease awareness, monitor signs and symptoms and will also get the support of a
respiratory coach. In addition, patients in this group will receive an electronic peak flow
meter to register daily variations in maximal expiratory flow and an electronic device to
connect to their inhaler to track adequate intake of inhaled medication. The control group
(CG) will receive usual care consisted of scheduled visitations to medical doctors every 4 -
8 weeks. Both groups will be evaluated at baseline, post-intervention (6 months) and at
follow up (one year) in the following variables: age, gender, asthma severity classification
according to international guidelines, date of diagnosis, weight, height, Body Mass Index
(BMI), forced expiratory volume in 1 second (FEV1), Asthma Control Questionnaire score,
treatment received for asthma, number of exacerbations in the previous 6 months and
concomitant diseases. Exacerbations will be defined as any worsening in asthma symptoms that
requires an increase in the usual therapy, an unscheduled physician visit, treatment in the
emergency room or hospitalization.
Overall Status
Not yet recruiting
Start Date
2020-09-01
Completion Date
2022-09-01
Primary Completion Date
2021-09-01
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Differences in asthma control inter-group |
6 months |
|
Differences in asthma control inter-group |
12 months |
Secondary Outcome
Measure |
Time Frame |
|
Changes in asthma control intra-group for the intervention group |
6 months |
|
Changes in asthma control intra-group for the intervention group |
12 months |
|
Changes in asthma control intra-group for the control group |
6 months |
|
Changes in asthma control intra-group for the control group |
12 months |
|
Inclusion rates (feasibility) |
Baseline |
|
Completion rates |
12 months |
|
Incidence of exacerbations |
12 months |
Enrollment
60
Condition
Intervention
Intervention Type
Behavioral
Intervention Name
Description
Happyair Ecosystem is a Smart Community for the integral care of patients with chronic or rare respiratory diseases such as Asthma, COPD or Alfa-1.
Our community provides online & offline training and resources in digital health and social care to patients, family, caregivers, healthcare professionals and researchers.
Using our platform, all of our members will be able to connect in order to improve the health and well-being of patients, learn to manage self-care, ensure an active lifestyle, and contribute to the development of current and future research projects.
Arm Group Label
Intervention Group
Eligibility
Criteria
Inclusion Criteria:
- children between 6 and 18 years old;
- diagnosis of moderate to severe persistent asthma according to the international
guidelines
- difficult to control asthma according to a scoring in the Asthma Control Questionnaire
(ACQ) of 1.5 points;
- access to internet and a smartphone, tablet or computer;
- ability to understand and use the web-based platform (in children <12 years the
ability of the tutor or legal guardian);
- informed consent (by the tutor or legal guardian)
Exclusion Criteria:
- patients who have had an exacerbation in the previous two weeks;
- patients with intermittent asthma and/or well-controlled asthma according to the ACQ
score of <1.5;
- any neurological or psychiatric condition that prevents patients to use adequately the
platform.
Gender
All
Minimum Age
6 Years
Maximum Age
18 Years
Healthy Volunteers
No
Verification Date
2019-11-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor-Investigator
Investigator Affiliation
Lovexair Foundation
Investigator Full Name
Raquel Sebio
Investigator Title
Lecturer
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Arm Group
Arm Group Label
Intervention Group
Arm Group Type
Experimental
Description
Participants in the IG will be given free access to the HappyAir platform during a 6-month period. This platform combines online/offline content to help patients with chronic respiratory diseases monitor their symptoms and improve self-management. In addition to tailored information on their condition, participants will be encouraged to fill in daily data on their physical activity levels, symptomatology, use of rescue medication and mood. In children under 12 years, parents or caregivers will fill in this information. Patients will be asked to record their peak expiratory flow using an electronic peak flow meter twice daily and to fulfil the Asthma Control Questionnaire once a week. They will also have a device connected to their inhaler to record adherence to the medical treatment and will get daily reminders in their smartphones. Every patient will be assigned a respiratory coach who will monitor patient during the study and whom the patients can contact at any time.
Arm Group Label
Control Group
Arm Group Type
No Intervention
Description
Subjects in the CG will receive standard care consisting of periodic visitations at the Allergology or Paediatric Pulmonology Unit in their respective hospitals every 4 - 8 weeks according to their physician's criteria. In addition, patients and caregivers in both groups will receive one educational session regarding the correct use of their inhalers.
Firstreceived Results Date
N/A
Reference
Citation
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Citation
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PMID
19014848
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
Single (Investigator)
Study First Submitted
November 13, 2019
Study First Submitted Qc
November 15, 2019
Study First Posted
November 18, 2019
Last Update Submitted
November 15, 2019
Last Update Submitted Qc
November 15, 2019
Last Update Posted
November 18, 2019
ClinicalTrials.gov processed this data on December 09, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.