Digital Action Plan (Web App) for Managing Asthma Exacerbations: Randomized Controlled Trial.
action plan
asthma exacerbation
mobile phone
web application
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
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
e41490Informations 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.
Références
Thorax. 2020 Dec;75(12):1119-1129
pubmed: 32839286
N Engl J Med. 2018 Mar 8;378(10):902-910
pubmed: 29504499
Pediatr Allergy Immunol Pulmonol. 2016 Sep;29(3):130-136
pubmed: 35923055
J Allergy Clin Immunol Pract. 2021 Jun;9(6):2377-2398
pubmed: 33652136
N Engl J Med. 2018 Mar 08;378(10):891-901
pubmed: 29504498
J Allergy Clin Immunol. 2012 Aug;130(2):332-42.e10
pubmed: 22694932
J Med Internet Res. 2021 Apr 13;23(4):e22432
pubmed: 33847592
J Med Internet Res. 2014 Feb 18;16(2):e51
pubmed: 24550161
BMJ. 2016 Mar 17;352:i1174
pubmed: 26988021
Am J Respir Crit Care Med. 2009 Jul 1;180(1):59-99
pubmed: 19535666
J Pharm Technol. 2019 Jun;35(3):126-134
pubmed: 34861010
BMC Med. 2012 Nov 22;10:144
pubmed: 23171675
Eur Respir J. 2011 Feb;37(2):310-7
pubmed: 20562122
Lancet Respir Med. 2013 Mar;1(1):32-42
pubmed: 24321802
BMJ. 2012 Mar 23;344:e1756
pubmed: 22446569
Cochrane Database Syst Rev. 2017 Apr 10;4:CD011859
pubmed: 28394084
Rev Mal Respir. 2016 May;33(5):365-76
pubmed: 26545450
Am J Respir Crit Care Med. 2015 Jun 15;191(12):1374-83
pubmed: 25867075
J Med Internet Res. 2016 Dec 01;18(12):e313
pubmed: 27908846
J Med Internet Res. 2013 Sep 12;15(9):e188
pubmed: 24028826
J Allergy Clin Immunol Pract. 2020 Oct;8(9):3011-3020.e2
pubmed: 32344187
J Allergy Clin Immunol Pract. 2021 Apr;9(4):1728-1730.e3
pubmed: 33290917
JMIR Mhealth Uhealth. 2021 Jul 16;9(7):e24127
pubmed: 34269684
Cochrane Database Syst Rev. 2013 Nov 27;(11):CD010013
pubmed: 24282112
Patient Educ Couns. 2011 Nov;85(2):e131-43
pubmed: 21396793
Cochrane Database Syst Rev. 2003;(1):CD001117
pubmed: 12535399
Cochrane Database Syst Rev. 2006 Jul 19;(3):CD005306
pubmed: 16856090
Pediatr Allergy Immunol Pulmonol. 2016 Mar 1;29(1):2-5
pubmed: 27158550
Curr Allergy Asthma Rep. 2019 Feb 2;19(1):6
pubmed: 30712150
Rev Mal Respir. 2007 Apr;24(4 Pt 1):427-39
pubmed: 17468701
Rev Mal Respir. 2017 Nov;34(9):1026-1033
pubmed: 28927680