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

NCT03964740 | Unknown

• 1 other identifier: PI14/01946
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Obesity

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (14)

• Change in % FEV1 from baseline to weeks 8 and 24.

  6 months

• Change in the Tiffenau index (FEV1/FVC (Forced Vital Capacity) from baseline to endpoint.

  1 year

• Change in the Tiffenau index (FEV1/FVC) from baseline to weeks 8 and 24.

  6 months

• Change in the Body Mass Index (BMI) (measured in kg/m^2) from baseline to endpoint

  1 year

• Change in abdominal perimeter (measured in cm) from baseline to endpoint

  1 year

Study Arms (2)

Intervention

EXPERIMENTAL

Mobile App intervention group

Other: Mobile App intervention

Control Group

NO INTERVENTION

No intervention group

Interventions

Mobile App intervention 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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Virgen Macarena: lead

Study Sites (1)

Service of Allergology. Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

MeSH Terms

Conditions

Asthma; Obesity

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pedro Guardia, PhD, MD

  Service of Allergology. Hospital Universitario Virgen Macarena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: May 28, 2019
• Study Start: January 17, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: May 28, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)