AsthmaASMATICNCT03964740
Effectiveness and Efficiency of Mobile Technology in Disease Control of Asthmatic Obese Patients
A study testing Mobile App intervention in people with Asthma and Obesity, run by Hospital Universitario Virgen Macarena at 1 site in Spain.
Trial summary
Single-center open-label randomized pilot study to assess the effectiveness and efficiency of a mobile technology based intervention for asthma and obesity control. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Mobile App intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSpain
- Study dates
- 17 Jan 2018to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 y.o. or more.
- Diagnosis of asthma, confirmed by spirometry: positive post bronchodilator test (PBT), defined as an improvement of at least 12% and an increment of at least 200 ml in the absolute value of FEV1 following B-agonist inhalation. In case of negative PBT, asthma diagnoses could be establish if a positive result, defined as a PC20< 8 pgr, was achieved in the Methacholine Challenge Test (MCT).
- BMI of 25 or more.
- Subjects must meet criteria of acceptability of spirometry in at least in three manoeuvres (within a maximun of 8). Acceptability of a spirometry for this protocol purpose is defined by: a) minimum of 6 second exhalation time; b) no cough detected in the first second of expiration; c) 1 second volume plateau.
- Subjects must meet criteria of repeatability of spirometry, defined for this protocol purpose as the three highest accepted FEV1 values to be within 0.10L (100mL) of each other or with a variability of 5% or less.
- Subjects with capacity to handle a smartphone device, with incorporated Android system, and to use and input data on the app ASMATIC, designed for this study purposes.
- Subjects willing to give voluntary, signed informed consent, in accordance with Good Clinical Practice (GCP) guidelines.
Who cannot join
- Subjects with uncontrolled or severe asthma at study entry, defined by at least one of the following criteria: a) FEV1 <80% of the theorical calculated value and a FEV1/FVC ratio <75% at study entry; b) any severe asthma exacerbation within the two months previous to study entry; c) systemic corticoid or any biological treatment received in the previous 6 months to study entry.
- Any known contraindication for bronchodilator reversibility testing or bronchial provocation tests such us: a) any respiratory tract infection in the previous month to selection; b) pregnancy, lactation or intention to become pregnant during the study; or c) any other contraindication for spirometry found following clinical criteria.
- Subjects with any limitation in their capacity to collaborate and comply with study requirements.
- Active smokers or ex-smokers in the 6 months previous to study entry.
- Subjects currently in immunotherapy treatment or potential candidates for it, including subject suffering a malignant disease.
- Subjects with asthma non controlled risk factors.
- Subjects with any severe or non controlled pathology that compromise their safety during their participation study.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Service of Allergology. Hospital Universitario Virgen Macarena
Seville, 41009
About this study
Official title: Effectiveness and Efficiency of Mobile Technology in Disease Control and Healthy Lifestyle Promotion in Asthmatic Overweight/Obese Patients. A Pilot Study.
Single-center open-label randomized pilot study to assess the effectiveness and efficiency of a mobile technology based intervention for asthma and obesity control.
Read the detailed description
Single-center open-label randomized pilot study to assess the effectiveness and efficiency of a mobile technology based intervention for asthma and obesity control. The interventional group subjects received a mobile device with an ad-hoc designed application (called ASMATIC) which permitted them to record asthma control variables (peak-flow and presence of core symptoms), have daily reminders on their medication for asthma control and advice for healthy lifestyle habits, including personalized diet recommendations and exercise monitoring. The device also permits a bidirectional communication between the patient and the study staff for reporting any emerging issues related to the asthmatic condition of the patient, as the need of additional in-personconsultations. The control group is followed-up based on the study site usual clinical practice, without any specific intervention.
The primary study objective is to evaluate whether the use of the ASMATIC mobile application use improves parameters of asthma control, obesity control, asthma obese patient's quality of life and if it's associated with savings in health-related costs (efficiency assessment), compared to the usual clinical practice.
- Being tested
- Mobile App intervention
- Medical subject headings
- Asthma, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile App interventionOther
The intervention is based on the interventional group subjects use of a mobile device with an ad-hoc designed application (called ASMATIC). This app permit them (in a daily basis) to record asthma control variables (peak-flow and presence of core symptoms), have daily reminders on their medication for asthma control and decision support for patient disease self-management; and contains advice on healthy lifestyle habits, including personalized diet recommendations based on clinical criteria and associated recipes. The device also permits the study subject to communicate with the hospital and for the study team to review potential issues of interest on the patient's asthma control parameters which might need an intervention such us additional in-person consultations
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Mobile App intervention group Receives: Other: Mobile App intervention |
| Control Group | No intervention | No intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in % of Forced Expiratory Volume in the first second (FEV1) from baseline to endpoint
Asthma control assessed through the change in % FEV1 from baseline to endpoint in the interventional group and between the interventional and control groups.
Measured: 1 year
Secondary outcomes (14)
Change in % FEV1 from baseline to weeks 8 and 24.
Asthma control assessed through the change in % FEV1 from baseline to weeks 8 and 24 within the interventional group and between the interventional and control groups.
Measured: 6 months
Change in the Tiffenau index (FEV1/FVC (Forced Vital Capacity) from baseline to endpoint.
Asthma control assessed through the change in the Tiffenau index (FEV1/FVC) from baseline to endpoint in the interventional group and between the interventional and control groups.
Measured: 1 year
Change in the Tiffenau index (FEV1/FVC) from baseline to weeks 8 and 24.
Asthma control assessed through the change in the Tiffenau index (FEV1/FVC) from baseline to weeks 8 and 24 within the interventional group and between the interventional and control groups.
Measured: 6 months
Change in the Body Mass Index (BMI) (measured in kg/m^2) from baseline to endpoint
Change in BMI (measured in kg/m^2) from baseline to endpoint. Comparison within the interventional group and between intervention and control group
Measured: 1 year
Change in abdominal perimeter (measured in cm) from baseline to endpoint
Change in abdominal perimeter (measured in cm) from baseline to endpoint. Comparison within the interventional group and between intervention and control group
Measured: 1 year
Change in neck perimeter (measured in cm) from baseline to endpoint (in male study subjects).
Change in neck perimeter (measured in cm) from baseline to endpoint (in male study subjects). Comparison within the interventional group and between intervention and control group
Measured: 1 year
Change in hip perimeter (measured in cm) from baseline to endpoint (in female study subjects).
Change in hip perimeter (measured in cm) from baseline to endpoint (in female study subjects). Comparison within the interventional group and between intervention and control group
Measured: 1 year
Changes in the Asthma Quality of Life Questionnaire (AQLQ) score from baseline to endpoint
Change in the Asthma Quality of Life Questionnaire (AQLQ) score from baseline to endpoint. AQLQ is a 5-item questionnaire, with a range of scores per item between 0 and 5, and a total range of score range of 0 to 25 points. The comparison is to be made within the interventional group and between intervention and control group.
Measured: 1 year
Change in number of Quality-Adjusted Life Years (QALYs) from baseline to endpoint.
Calculated through the EQ-5D (Euro-Quality of Life Questionnaire of 5 Dimensions) score change from baseline to endpoint. Comparison made between intervention and control group
Measured: 1 year
Healthcare costs of the mean ER consultations related to asthmatic symptoms exacerbation reported by the study subjects during the whole study (measured in euros)
Evaluation of health economic impact of using the mobile app ASMATIC assessed through associated costs of the mean number of visits to ER related to asthmatic symptoms exacerbation reported by the study subjects (measured in euros) during the whole study period in the interventional group vs. the control group. Each consultation in ER has a pre-established cost based on the Andalusian Public Health System standards.
Measured: 1 year
Healthcare costs of Primary Care consultations related to asthmatic symptoms exacerbation reported by the study subjects during the whole study (measured in euros)
Evaluation of health economic impact of using the mobile app ASMATIC assessed through associated costs of the mean number of visits to the Primary Care Physician related to asthmatic symptoms exacerbation reported by the study subjects during the whole study period. Each consultation with the Primary Care Physician has a pre-established cost based on the Andalusian Public Health System standards. Comparison between the interventional group vs. the control group.
Measured: 1 year
Healthcare costs of consultations with the Allergologist (measured in euros)
Evaluation of health economic impact of using the mobile app ASMATIC assessed through associated costs of the mean number of consultations with the Allergologist, measured in euros, during the whole study period in the interventional group vs. the control group. Each consultation with the Allergologist has a pre-established cost based on the Andalusian Public Health System standards.
Measured: 1 year
Total healthcare costs of the consultations in ER, Primary Care and Allergology Service related to the asthmatic condition reported by the patients during the whole study period (measured in euros)
Evaluation of health economic impact of using the mobile app ASMATIC assessed through the associated costs of the mean number of consultations in ER, Primary Care and Allergology Service related to the asthmatic condition reported by the patient during the whole study period (measured in euros). Comparison made in the interventional group vs. the control group. Each consultation in ER, with Primary Care and with the Allergologist has a pre-established cost based on the Andalusian Public Health System standards.
Measured: 1 year
Mean number of days of rescue medication use.
Mean number of days of rescue medication use during the whole study period. The outcome will be evaluated between the interventional and control groups.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start17 Jan 2018
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center open-label controlled pilot study. The interventional group receive a mobile device with an installed application for asthma and obesity control and have protocolized in-person ambulatory visits for asthma and nutrition parameters control while the control study follows a pattern of visits based on the usual clinical practice in the study site.
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Virgen Macarena
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pedro Guardia, PhD, MD, Principal investigator, Service of Allergology. Hospital Universitario Virgen Macarena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964740
- Sponsor's protocol ID
- PI14/01946
- Acronym
- ASMATIC
- Status last verified
- May 2019
- First submitted
- 23 May 2019
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Efficiency of Mobile Technology in Disease Control and Healthy Lifestyle Promotion in Asthmatic Overweight/Obese Patients. A Pilot Study.
- ClinicalTrials.gov ID
- NCT03964740
- Acronym / sponsor ID
- ASMATIC / PI14/01946
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Hospital Universitario Virgen MacarenaUniversity, hospital or other
- Study start
- 17 Jan 2018 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 28 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single-center open-label randomized pilot study to assess the effectiveness and efficiency of a mobile technology based intervention for asthma and obesity control.
Detailed description
Single-center open-label randomized pilot study to assess the effectiveness and efficiency of a mobile technology based intervention for asthma and obesity control. The interventional group subjects received a mobile device with an ad-hoc designed application (called ASMATIC) which permitted them to record asthma control variables (peak-flow and presence of core symptoms), have daily reminders on their medication for asthma control and advice for healthy lifestyle habits, including personalized diet recommendations and exercise monitoring. The device also permits a bidirectional communication between the patient and the study staff for reporting any emerging issues related to the asthmatic condition of the patient, as the need of additional in-personconsultations. The control group is followed-up based on the study site usual clinical practice, without any specific intervention.
The primary study objective is to evaluate whether the use of the ASMATIC mobile application use improves parameters of asthma control, obesity control, asthma obese patient's quality of life and if it's associated with savings in health-related costs (efficiency assessment), compared to the usual clinical practice.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-center open-label controlled pilot study. The interventional group receive a mobile device with an installed application for asthma and obesity control and have protocolized in-person ambulatory visits for asthma and nutrition parameters control while the control study follows a pattern of visits based on the usual clinical practice in the study site.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Mobile App interventionMobile App intervention group |
| Control Group | No intervention | –No intervention group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 y.o. or more.
- Diagnosis of asthma, confirmed by spirometry: positive post bronchodilator test (PBT), defined as an improvement of at least 12% and an increment of at least 200 ml in the absolute value of FEV1 following B-agonist inhalation. In case of negative PBT, asthma diagnoses could be establish if a positive result, defined as a PC20< 8 pgr, was achieved in the Methacholine Challenge Test (MCT).
- BMI of 25 or more.
- Subjects must meet criteria of acceptability of spirometry in at least in three manoeuvres (within a maximun of 8). Acceptability of a spirometry for this protocol purpose is defined by: a) minimum of 6 second exhalation time; b) no cough detected in the first second of expiration; c) 1 second volume plateau.
- Subjects must meet criteria of repeatability of spirometry, defined for this protocol purpose as the three highest accepted FEV1 values to be within 0.10L (100mL) of each other or with a variability of 5% or less.
Key exclusion criteria (7 listed)
- Subjects with uncontrolled or severe asthma at study entry, defined by at least one of the following criteria: a) FEV1 <80% of the theorical calculated value and a FEV1/FVC ratio <75% at study entry; b) any severe asthma exacerbation within the two months previous to study entry; c) systemic corticoid or any biological treatment received in the previous 6 months to study entry.
- Any known contraindication for bronchodilator reversibility testing or bronchial provocation tests such us: a) any respiratory tract infection in the previous month to selection; b) pregnancy, lactation or intention to become pregnant during the study; or c) any other contraindication for spirometry found following clinical criteria.
- Subjects with any limitation in their capacity to collaborate and comply with study requirements.
- Active smokers or ex-smokers in the 6 months previous to study entry.
- Subjects currently in immunotherapy treatment or potential candidates for it, including subject suffering a malignant disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile App interventionThe intervention is based on the interventional group subjects use of a mobile device with an ad-hoc designed application (called ASMATIC). This app permit them (in a daily basis) to record asthma control variables (peak-flow and presence of core symptoms), have daily reminders on their medication for asthma control and decision support for patient disease self-management; and contains advice on healthy lifestyle habits, including personalized diet recommendations based on clinical criteria and associated recipes. The device also permits the study subject to communicate with the hospital and for the study team to review potential issues of interest on the patient's asthma control parameters which might need an intervention such us additional in-person consultations | Other | Intervention |
Primary outcome
Change in % of Forced Expiratory Volume in the first second (FEV1) from baseline to endpoint
Time frame: 1 year
Asthma control assessed through the change in % FEV1 from baseline to endpoint in the interventional group and between the interventional and control groups.
14 secondary outcomes
Change in % FEV1 from baseline to weeks 8 and 24.
Time frame: 6 months
Change in the Tiffenau index (FEV1/FVC (Forced Vital Capacity) from baseline to endpoint.
Time frame: 1 year
Change in the Tiffenau index (FEV1/FVC) from baseline to weeks 8 and 24.
Time frame: 6 months
Change in the Body Mass Index (BMI) (measured in kg/m^2) from baseline to endpoint
Time frame: 1 year
Change in abdominal perimeter (measured in cm) from baseline to endpoint
Time frame: 1 year
Change in neck perimeter (measured in cm) from baseline to endpoint (in male study subjects).
Time frame: 1 year
Change in hip perimeter (measured in cm) from baseline to endpoint (in female study subjects).
Time frame: 1 year
Changes in the Asthma Quality of Life Questionnaire (AQLQ) score from baseline to endpoint
Time frame: 1 year
Change in number of Quality-Adjusted Life Years (QALYs) from baseline to endpoint.
Time frame: 1 year
Healthcare costs of the mean ER consultations related to asthmatic symptoms exacerbation reported by the study subjects during the whole study (measured in euros)
Time frame: 1 year
Healthcare costs of Primary Care consultations related to asthmatic symptoms exacerbation reported by the study subjects during the whole study (measured in euros)
Time frame: 1 year
Healthcare costs of consultations with the Allergologist (measured in euros)
Time frame: 1 year
Total healthcare costs of the consultations in ER, Primary Care and Allergology Service related to the asthmatic condition reported by the patients during the whole study period (measured in euros)
Time frame: 1 year
Mean number of days of rescue medication use.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro Guardia, PhD, MD principal investigator
Service of Allergology. Hospital Universitario Virgen Macarena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile App intervention in people with Asthma and Obesity, run by Hospital Universitario Virgen Macarena at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in % of Forced Expiratory Volume in the first second (FEV1) from baseline to endpoint (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2019.