Digital Action Plan for Asthma Attacks

NCT02869958 | Completed

• 1 other identifier: P140316
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 2

Brief Summary

It is recommended that patients with asthma owned a written action plan which must include the names, doses and dosing of the treatment they should take when acute respiratory symptoms occur. Current written action plans must be short to be readily used (1 page) and, therefore, cannot fit all acute situations. Moreover, they may not be available where and when required. The investigators sought that a digital action plan, available through Smartphone or tablet computer connected to the internet, could adequately provide suitable action plans according to the severity of the described exacerbation, and would be more easily available when useful. The aim of the study is to study the effect of the use of a digital action plan for asthma exacerbation, on the frequency of unscheduled medical contacts (phone calls, visits to physicians or to emergency departments, hospitalizations) in children and in adults with asthma. The investigators hypothesized that the use of the digital action plan could reduce avoidable unscheduled visits due to mild or moderate exacerbations that could successfully be managed by the patient or his/her caregivers.

Conditions

Asthma

Keywords

Asthma; Exacerbation; Treatment; Internet; Emergency care

Outcome Measures

Primary Outcomes (2)

• Number of visits or unscheduled medical contacts

  Frequency of urgent medical recourses (composite criterion): visits or unscheduled medical contacts + Emergency Departments visits or hospitalizations, in both arms of randomization

  during the 1 year follow-up

• Emergency Departments visits or hospitalizations

  Frequency of urgent medical recourses (composite criterion): visits or unscheduled medical contacts + Emergency Departments visits or hospitalizations, in both arms of randomization

  during the 1 year follow-up

Secondary Outcomes (10)

• Adherence to the Digital Action Plan = number of moderate to severe exacerbations entered in the AppWeb with respect to all moderate to severe exacerbations reported

  during the 1 year follow-up

• Adherence to the Written Action Plan (number of times Written Action Plan was used with respect to all moderate to severe exacerbations)

  during the 1 year follow-up

• qualitative evaluation of the Digital Action Plan: descriptive study using a questionnaire filled out in the arm using the AppWeb

  at 1 year

• number of unscheduled visits or medical contacts during the 1 year follow-up

  during the 1 year follow-up

• number of visits in Emergency Departments

  during the 1 year follow-up

Study Arms (2)

1: Written action plan

ACTIVE COMPARATOR

Written action plan

Other: Written action plan

2: Digital action plan

EXPERIMENTAL

Written action plan + Digital action plan for asthma exacerbations Digital action plan for asthma exacerbation available through an AppWeb and requiring a connected device such as a Smartphone or a tablet computer. The patient must connect and describe the situation to obtain the names, doses and dosing of the treatment his/her physician has recommended for him/her according to the level of severity of the exacerbation

Other: Digital action plan for asthma exacerbations + Written action plan

Interventions

Digital action plan for asthma exacerbations + Written action plan OTHER

Digital action plan for asthma exacerbation available through an AppWeb and requiring a connected device such as a Smartphone or a tablet computer. The patient must connect and describe the situation to obtain the names, doses and dosing of the treatment his/her physician has recommended for him/her according to the level of severity of the exacerbation

Also known as: Digital action plan for asthma exacerbations

2: Digital action plan

Written action plan OTHER

1: Written action plan

Eligibility Criteria

• Age: 6 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• children from 6 to 12 years or adults aged between 18 and 60 years
• typical asthma with medical diagnosis
• severe exacerbation (requiring ≥ 3 days of oral corticosteroids) during the previous 12 months
• Internet connexion through a private (patient's or parents' patient's if child) smartphone and/or a tablet computer
• no use of a written actin plan within the last 1 year
• agreement to have phone calls or email contacts during the 1 year follow-up of the study
• informed consent given, signed consent
• affiliation to a social security

You may not qualify if:

• atypical asthma: isolated cough, exercise respiratory discomfort
• other respiratory disease (cystic fibrosis, COPD, etc.)
• Severe heart disease (except high blood pressure)
• smoking \> 15 pack-years
• asthma requiring regular oral corticosteroids treatment
• asthma requiring inhaled controller treatment administered via nebulizations performed at home
• no health insurance coverage
• sister or brother already included in this study (applies only to children)
• pregnancy and breastfeeding

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Hôpital Privé Armand Brillard

Nogent-sur-Marne, 94130, France

Location

MulticEnter French study coordinate by AP-HP

Paris, 75012, France

Location

Related Publications (1)

• Beydon N, Taille C, Corvol H, Valcke J, Portal JJ, Plantier L, Mangiapan G, Perisson C, Aubertin G, Hadchouel A, Briend G, Guilleminault L, Neukirch C, Cros P, Appere de Vecchi C, Mahut B, Vicaut E, Delclaux C. Digital Action Plan (Web App) for Managing Asthma Exacerbations: Randomized Controlled Trial. J Med Internet Res. 2023 Jun 29;25:e41490. doi: 10.2196/41490.

  PMID: 37255277 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Nicole BEYDON, MD

  Assistance Publique - Hôpitaux de Paris

  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

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: August 17, 2016
• Study Start: November 3, 2016
• Primary Completion: April 29, 2020
• Study Completion: April 29, 2020
• Last Updated: December 4, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)