Digital Action Plan (Web App) for Managing Asthma Exacerbations: Randomized Controlled Trial.


Journal

Journal of medical Internet research
ISSN: 1438-8871
Titre abrégé: J Med Internet Res
Pays: Canada
ID NLM: 100959882

Informations de publication

Date de publication:
29 06 2023
Historique:
received: 27 07 2022
accepted: 28 02 2023
revised: 30 11 2022
medline: 3 7 2023
pubmed: 31 5 2023
entrez: 31 5 2023
Statut: epublish

Résumé

A written action plan (WAP) for managing asthma exacerbations is recommended. We aimed to compare the effect on unscheduled medical contacts (UMCs) of a digital action plan (DAP) accessed via a smartphone web app combined with a WAP on paper versus that of the same WAP alone. This randomized, unblinded, multicenter (offline recruitment in private offices and public hospitals), and parallel-group trial included children (aged 6-12 years) or adults (aged 18-60 years) with asthma who had experienced at least 1 severe exacerbation in the previous year. They were randomized to a WAP or DAP+WAP group in a 1:1 ratio. The DAP (fully automated) provided treatment advice according to the severity and previous pharmacotherapy of the exacerbation. The DAP was an algorithm that recorded 3 to 9 clinical descriptors. In the app, the participant first assessed the severity of their current symptoms on a 10-point scale and then entered the symptom descriptors. Before the trial, the wordings and ordering of these descriptors were validated by 50 parents of children with asthma and 50 adults with asthma; the app was not modified during the trial. Participants were interviewed at 3, 6, 9, and 12 months to record exacerbations, UMCs, and WAP and DAP use, including the subjective evaluation (availability and usefulness) of the action plans, by a research nurse. Overall, 280 participants were randomized, of whom 33 (11.8%) were excluded because of the absence of follow-up data after randomization, leaving 247 (88.2%) participants (children: n=93, 37.7%; adults: n=154, 62.3%). The WAP group had 49.8% (123/247) of participants (children: n=45, 36.6%; mean age 8.3, SD 2.0 years; adults: n=78, 63.4%; mean age 36.3, SD 12.7 years), and the DAP+WAP group had 50.2% (124/247) of participants (children: n=48, 38.7%; mean age 9.0, SD 1.9 years; adults: n=76, 61.3%; mean age 34.5, SD 11.3 years). Overall, the annual severe exacerbation rate was 0.53 and not different between the 2 groups of participants. The mean number of UMCs per year was 0.31 (SD 0.62) in the WAP group and 0.37 (SD 0.82) in the DAP+WAP group (mean difference 0.06, 95% CI -0.12 to 0.24; P=.82). Use per patient with at least 1 moderate or severe exacerbation was higher for the WAP (33/65, 51% vs 15/63, 24% for the DAP; P=.002). Thus, participants were more likely to use the WAP than the DAP despite the nonsignificant difference between the action plans in the subjective evaluation. Median symptom severity of the self-evaluated exacerbation was 4 out of 10 and not significantly different from the symptom severity assessed by the app. The DAP was used less often than the WAP and did not decrease the number of UMCs compared with the WAP alone. ClinicalTrials.gov NCT02869958; https://clinicaltrials.gov/ct2/show/NCT02869958.

Sections du résumé

BACKGROUND
A written action plan (WAP) for managing asthma exacerbations is recommended.
OBJECTIVE
We aimed to compare the effect on unscheduled medical contacts (UMCs) of a digital action plan (DAP) accessed via a smartphone web app combined with a WAP on paper versus that of the same WAP alone.
METHODS
This randomized, unblinded, multicenter (offline recruitment in private offices and public hospitals), and parallel-group trial included children (aged 6-12 years) or adults (aged 18-60 years) with asthma who had experienced at least 1 severe exacerbation in the previous year. They were randomized to a WAP or DAP+WAP group in a 1:1 ratio. The DAP (fully automated) provided treatment advice according to the severity and previous pharmacotherapy of the exacerbation. The DAP was an algorithm that recorded 3 to 9 clinical descriptors. In the app, the participant first assessed the severity of their current symptoms on a 10-point scale and then entered the symptom descriptors. Before the trial, the wordings and ordering of these descriptors were validated by 50 parents of children with asthma and 50 adults with asthma; the app was not modified during the trial. Participants were interviewed at 3, 6, 9, and 12 months to record exacerbations, UMCs, and WAP and DAP use, including the subjective evaluation (availability and usefulness) of the action plans, by a research nurse.
RESULTS
Overall, 280 participants were randomized, of whom 33 (11.8%) were excluded because of the absence of follow-up data after randomization, leaving 247 (88.2%) participants (children: n=93, 37.7%; adults: n=154, 62.3%). The WAP group had 49.8% (123/247) of participants (children: n=45, 36.6%; mean age 8.3, SD 2.0 years; adults: n=78, 63.4%; mean age 36.3, SD 12.7 years), and the DAP+WAP group had 50.2% (124/247) of participants (children: n=48, 38.7%; mean age 9.0, SD 1.9 years; adults: n=76, 61.3%; mean age 34.5, SD 11.3 years). Overall, the annual severe exacerbation rate was 0.53 and not different between the 2 groups of participants. The mean number of UMCs per year was 0.31 (SD 0.62) in the WAP group and 0.37 (SD 0.82) in the DAP+WAP group (mean difference 0.06, 95% CI -0.12 to 0.24; P=.82). Use per patient with at least 1 moderate or severe exacerbation was higher for the WAP (33/65, 51% vs 15/63, 24% for the DAP; P=.002). Thus, participants were more likely to use the WAP than the DAP despite the nonsignificant difference between the action plans in the subjective evaluation. Median symptom severity of the self-evaluated exacerbation was 4 out of 10 and not significantly different from the symptom severity assessed by the app.
CONCLUSIONS
The DAP was used less often than the WAP and did not decrease the number of UMCs compared with the WAP alone.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02869958; https://clinicaltrials.gov/ct2/show/NCT02869958.

Identifiants

pubmed: 37255277
pii: v25i1e41490
doi: 10.2196/41490
pmc: PMC10365576
doi:

Substances chimiques

Anti-Asthmatic Agents 0

Banques de données

ClinicalTrials.gov
['NCT02869958']

Types de publication

Randomized Controlled Trial Multicenter Study Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e41490

Informations de copyright

©Nicole Beydon, Camille Taillé, Harriet Corvol, Judith Valcke, Jean-Jacques Portal, Laurent Plantier, Gilles Mangiapan, Caroline Perisson, Guillaume Aubertin, Alice Hadchouel, Guillaume Briend, Laurent Guilleminault, Catherine Neukirch, Pierrick Cros, Corinne Appere de Vecchi, Bruno Mahut, Eric Vicaut, Christophe Delclaux. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 29.06.2023.

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Auteurs

Nicole Beydon (N)

Unité Fonctionnelle de Physiologie-Explorations Fonctionnelles Respiratoires, Institut National de la Santé et de la Recherche Médicale 938, Centre de Recherche Saint Antoine, Hôpital Armand Trousseau, Assistance Publique Hôpitaux de Paris, F-75012, Paris, France.

Camille Taillé (C)

Service de Pneumologie et Centre de Référence Constitutif des Maladies Pulmonaires Rares, Hôpital Bichat, Assistance Publique Hôpitaux de Paris, Institut National de la Santé et de la Recherche Médicale 1152, Université Paris Cité, F-75018, Paris, France.

Harriet Corvol (H)

Service de Pneumologie Pédiatrique, Hôpital Armand Trousseau, Assistance Publique Hôpitaux de Paris, Institut National de la Santé et de la Recherche Médicale Centre de Recherche Saint-Antoine, Sorbonne Université, F-75012, Paris, France.

Judith Valcke (J)

Service de Pneumologie, Hôpital Européen Georges Pompidou, Assistance Publique Hôpitaux de Paris, F-75015 Paris, Hôpital Privé Armand Brillard, F-94130, Paris, France.

Jean-Jacques Portal (JJ)

Clinical Research Unit Saint-Louis Lariboisière, Assistance Publique Hôpitaux de Paris, Université de Paris Cité, F-75010, Paris, France.

Laurent Plantier (L)

Département de Pneumologie et Explorations Fonctionnelles Respiratoires, Centre Hospitalier Universitaire de Tours, Institut National de la Santé et de la Recherche Médicale unité 1100, Université de Tours, F-37000, Tours, France.

Gilles Mangiapan (G)

Service de Pneumologie, Centre Hospitalier Interrégional de Créteil, F-94010, Créteil, France.

Caroline Perisson (C)

Service de Pneumologie Pédiatrique, Hôpital Armand Trousseau, Assistance Publique Hôpitaux de Paris, Institut National de la Santé et de la Recherche Médicale Centre de Recherche Saint-Antoine, Sorbonne Université, F-75012, Paris, France.

Guillaume Aubertin (G)

Centre de pneumologie et d'allergologie de l'enfant, F-92100, Boulogne Billancourt, France.

Alice Hadchouel (A)

Service de Pneumologie Pédiatrique, Centre de Référence pour les Maladies Respiratoires Rares de l'Enfant, Hôpital Universitaire Necker-Enfants Malades, Assistance Publique Hôpitaux de Paris, Université de Paris Cité, F-75015, Paris, France.

Guillaume Briend (G)

Service de Pneumologie, Centre hospitalier de Pontoise, F-95303, Cergy Pontoise, France.

Laurent Guilleminault (L)

Département de Pneumologie et Allergologie, Centre Hospitalo-Universitaire Purpan, Centre National de la Recherche Scientifique U5282, Institut National de la Santé et de la Recherche Médicale U1291, Toulouse Institute for Infectious, Inflammatory Disease, Toulouse, France.

Catherine Neukirch (C)

Service de Pneumologie et Centre de Référence Constitutif des Maladies Pulmonaires Rares, Hôpital Bichat, Assistance Publique des Hôpitaux de Paris, Institut National de la Santé et de la Recherche Médicale 1152, F-75018, Paris, France.

Pierrick Cros (P)

Département de Pédiatrie, Hôpital Universitaire Morvan, F-29200, Brest, France.

Corinne Appere de Vecchi (C)

Service de Pneumologie, Centre Hospitalier Victor Dupouy, F-95100, Argenteuil, France.

Bruno Mahut (B)

Cabinet La Berma, F-92160, Antony, France.

Eric Vicaut (E)

Clinical Research Unit Saint-Louis Lariboisière, Assistance Publique Hôpitaux de Paris, Université de Paris Cité, F-75010, Paris, France.

Christophe Delclaux (C)

Service de Physiologie Pédiatrique-Centre du Sommeil, Hôpital Robert Debré, Assistance Publique Hôpitaux de Paris, Institut National de la Santé et de la Recherche Médicale NeuroDiderot, Université de Paris Cité, F-75019, Paris, France.

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