Back to resultsEffectiveness and Efficiency of Mobile Technology in Disease Control of Asthmatic Obese Patients (ASMATIC)
Primary Purpose
Asthma, Obesity
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Mobile App intervention
Sponsored by
About this trial
This is an interventional other trial for Asthma
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Service of Allergology. Hospital Universitario Virgen Macarena
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control Group
Arm Description
Mobile App intervention group
No intervention group
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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
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
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
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
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.
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
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03964740
First Posted
May 23, 2019
Last Updated
May 24, 2019
Sponsor
Hospital Universitario Virgen Macarena
1. Study Identification
Unique Protocol Identification Number
NCT03964740
Brief Title
Effectiveness and Efficiency of Mobile Technology in Disease Control of Asthmatic Obese Patients
Acronym
ASMATIC
Official Title
Effectiveness and Efficiency of Mobile Technology in Disease Control and Healthy Lifestyle Promotion in Asthmatic Overweight/Obese Patients. A Pilot Study.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 17, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitario Virgen Macarena
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Obesity
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Mobile App intervention group
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No intervention group
Intervention Type
Other
Intervention Name(s)
Mobile App intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in % of Forced Expiratory Volume in the first second (FEV1) from baseline to endpoint
Description
Asthma control assessed through the change in % FEV1 from baseline to endpoint in the interventional group and between the interventional and control groups.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change in % FEV1 from baseline to weeks 8 and 24.
Description
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.
Time Frame
6 months
Title
Change in the Tiffenau index (FEV1/FVC (Forced Vital Capacity) from baseline to endpoint.
Description
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.
Time Frame
1 year
Title
Change in the Tiffenau index (FEV1/FVC) from baseline to weeks 8 and 24.
Description
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.
Time Frame
6 months
Title
Change in the Body Mass Index (BMI) (measured in kg/m^2) from baseline to endpoint
Description
Change in BMI (measured in kg/m^2) from baseline to endpoint. Comparison within the interventional group and between intervention and control group
Time Frame
1 year
Title
Change in abdominal perimeter (measured in cm) from baseline to endpoint
Description
Change in abdominal perimeter (measured in cm) from baseline to endpoint. Comparison within the interventional group and between intervention and control group
Time Frame
1 year
Title
Change in neck perimeter (measured in cm) from baseline to endpoint (in male study subjects).
Description
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
Time Frame
1 year
Title
Change in hip perimeter (measured in cm) from baseline to endpoint (in female study subjects).
Description
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
Time Frame
1 year
Title
Changes in the Asthma Quality of Life Questionnaire (AQLQ) score from baseline to endpoint
Description
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.
Time Frame
1 year
Title
Change in number of Quality-Adjusted Life Years (QALYs) from baseline to endpoint.
Description
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
Time Frame
1 year
Title
Healthcare costs of the mean ER consultations related to asthmatic symptoms exacerbation reported by the study subjects during the whole study (measured in euros)
Description
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.
Time Frame
1 year
Title
Healthcare costs of Primary Care consultations related to asthmatic symptoms exacerbation reported by the study subjects during the whole study (measured in euros)
Description
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.
Time Frame
1 year
Title
Healthcare costs of consultations with the Allergologist (measured in euros)
Description
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.
Time Frame
1 year
Title
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)
Description
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.
Time Frame
1 year
Title
Mean number of days of rescue medication use.
Description
Mean number of days of rescue medication use during the whole study period. The outcome will be evaluated between the interventional and control groups.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Guardia, PhD, MD
Organizational Affiliation
Service of Allergology. Hospital Universitario Virgen Macarena
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service of Allergology. Hospital Universitario Virgen Macarena
City
Seville
ZIP/Postal Code
41009
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness and Efficiency of Mobile Technology in Disease Control of Asthmatic Obese Patients
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