Effectiveness and Efficiency of Mobile Technology in Disease Control of Asthmatic Obese Patients

NCT ID: NCT03964740

Last Updated: 2019-05-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-17
• Study Completion Date: 2019-06-30

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.

Conditions

Asthma; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention

Mobile App intervention group

Group Type: EXPERIMENTAL

Mobile App intervention

Intervention Type: OTHER

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

Control Group

No intervention group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mobile App intervention

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario Virgen Macarena

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pedro Guardia, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Service of Allergology. Hospital Universitario Virgen Macarena

Locations

Service of Allergology. Hospital Universitario Virgen Macarena

Seville, , Spain

Countries

Spain

Other Identifiers

PI14/01946

Identifier Type: -

Identifier Source: org_study_id