The PRINTEMPS study: protocol of a cluster-randomized controlled trial of the local promotion of a smartphone application and associated website for the prevention of suicidal behaviors in the adult general population in France.
Adult
Cluster Analysis
Cost-Benefit Analysis
Female
Follow-Up Studies
France
Health Promotion
/ economics
Humans
Male
Mental Health
Mobile Applications
/ economics
Program Evaluation
Psychological Distress
Randomized Controlled Trials as Topic
Smartphone
Suicide
/ psychology
Telemedicine
/ economics
Suicide Prevention
E-health
General population
Help-seeking
Intervention
Local authorities
Mental health
Prevention
Promotion
Psychological distress
Suicide
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
22 Jun 2020
22 Jun 2020
Historique:
received:
29
01
2020
accepted:
27
05
2020
entrez:
24
6
2020
pubmed:
24
6
2020
medline:
18
3
2021
Statut:
epublish
Résumé
Suicide constitutes a cause of death which could be prevented by e-health programs accessible to the general population. Effective promotion has the potential to maximize the uptake of such programs. However, few e-health programs have been combined with promotion campaigns. The primary objective of this trial is to assess the effectiveness of a tailored promotion, at a local level, of a mobile application and website offering evidence-based content for suicide prevention (the StopBlues program), and to compare the effectiveness of two types of local promotion in terms of their impact on suicidal acts. Secondary objectives focus on the effectiveness of the promotion in terms of the intensity of utilization of the StopBlues program, help-seeking behaviors and the level of psychological impairment of program users. This is a three-arm, parallel-group, cluster-randomized controlled trial, with before-and-after observation. Thirty-four clusters, corresponding to geographical areas sharing a common local authority in France, will be included. They will be randomly assigned to one of the following arms with a ratio of 1:1:1: a control group; a basic promotion group in which promotion of the StopBlues program will be done by local authorities; and an intensified promotion group in which basic promotion will be supplemented by an additional one in a general practitioner's waiting room. The primary outcome measure will be the number of suicidal acts within each cluster over a 12-month period following the launch of the intervention. Baseline data will be collected for each cluster over the 12-month period prior to the trial. Secondary outcomes will include length of use of the StopBlues program, measures of help-seeking behaviors and level of psychological distress among users of the program, as well as the cost-effectiveness and budgetary impact of its promotion. A more sustained promotion by local authorities will also be implemented after 12 months in the control group and assessed using the same outcome measures. This research should contribute to the sparse evidence base regarding the promotion of e-health programs and will support the wider delivery of the intervention evaluated if proven effective. ClinicalTrials.gov, ID: NCT03565562. Registered on 11 June 2018.
Sections du résumé
BACKGROUND
BACKGROUND
Suicide constitutes a cause of death which could be prevented by e-health programs accessible to the general population. Effective promotion has the potential to maximize the uptake of such programs. However, few e-health programs have been combined with promotion campaigns. The primary objective of this trial is to assess the effectiveness of a tailored promotion, at a local level, of a mobile application and website offering evidence-based content for suicide prevention (the StopBlues program), and to compare the effectiveness of two types of local promotion in terms of their impact on suicidal acts. Secondary objectives focus on the effectiveness of the promotion in terms of the intensity of utilization of the StopBlues program, help-seeking behaviors and the level of psychological impairment of program users.
METHODS/DESIGN
METHODS
This is a three-arm, parallel-group, cluster-randomized controlled trial, with before-and-after observation. Thirty-four clusters, corresponding to geographical areas sharing a common local authority in France, will be included. They will be randomly assigned to one of the following arms with a ratio of 1:1:1: a control group; a basic promotion group in which promotion of the StopBlues program will be done by local authorities; and an intensified promotion group in which basic promotion will be supplemented by an additional one in a general practitioner's waiting room. The primary outcome measure will be the number of suicidal acts within each cluster over a 12-month period following the launch of the intervention. Baseline data will be collected for each cluster over the 12-month period prior to the trial. Secondary outcomes will include length of use of the StopBlues program, measures of help-seeking behaviors and level of psychological distress among users of the program, as well as the cost-effectiveness and budgetary impact of its promotion. A more sustained promotion by local authorities will also be implemented after 12 months in the control group and assessed using the same outcome measures.
DISCUSSION
CONCLUSIONS
This research should contribute to the sparse evidence base regarding the promotion of e-health programs and will support the wider delivery of the intervention evaluated if proven effective.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov, ID: NCT03565562. Registered on 11 June 2018.
Identifiants
pubmed: 32571432
doi: 10.1186/s13063-020-04464-2
pii: 10.1186/s13063-020-04464-2
pmc: PMC7309990
doi:
Banques de données
ClinicalTrials.gov
['NCT03565562']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
553Subventions
Organisme : Institut de recherche en santé publique
ID : 026/14
Références
Behav Med. 2014;40(2):65-70
pubmed: 24754441
Health Qual Life Outcomes. 2009 Mar 05;7:22
pubmed: 19265516
Br J Psychiatry. 2006 Sep;189:273-7
pubmed: 16946364
Health Syst Transit. 2015;17(3):1-218, xvii
pubmed: 26766545
BMJ. 2015 Mar 19;350:h1258
pubmed: 25791983
BMJ. 2014 Mar 07;348:g1687
pubmed: 24609605
PLoS One. 2013 Sep 23;8(9):e75081
pubmed: 24086443
PLoS One. 2019 Nov 11;14(11):e0224602
pubmed: 31710620
Ann Intern Med. 2013 Feb 5;158(3):200-7
pubmed: 23295957
PLoS One. 2013 Oct 09;8(10):e74902
pubmed: 24130673
J Gen Intern Med. 2001 Sep;16(9):606-13
pubmed: 11556941
Int J Public Health. 2016 Dec;61(9):1031-1038
pubmed: 27063950
Adolescence. 2009 Summer;44(174):335-46
pubmed: 19764270
Int J Circumpolar Health. 2009 Jun;68(3):274-91
pubmed: 19705659
Arch Intern Med. 2006 May 22;166(10):1092-7
pubmed: 16717171
PLoS Med. 2012;9(11):e1001346
pubmed: 23185138
Epilepsy Behav. 2016 Apr;57(Pt A):211-216
pubmed: 26994447
J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57
pubmed: 9881538
Encephale. 2009 Dec;35(6):560-9
pubmed: 20004287
Psychooncology. 2009 Jan;18(1):14-22
pubmed: 18457335
PLoS One. 2016 Apr 13;11(4):e0152285
pubmed: 27073900
J Psychiatr Res. 2019 Jun;113:46-50
pubmed: 30897371
BMJ. 2010 Mar 23;340:c332
pubmed: 20332509
BMJ. 2016 Aug 16;354:i4291
pubmed: 27530617
J Affect Disord. 2014 Oct;168:65-71
pubmed: 25038293
Health Serv Res. 2013 Dec;48(6 Pt 2):2224-44
pubmed: 24138608
Trials. 2011 Mar 11;12:75
pubmed: 21396089
Br J Gen Pract. 2009 Nov;59(568):825-32
pubmed: 19861027
PLoS One. 2012;7(12):e52028
pubmed: 23251676
Br J Psychiatry. 1979 Apr;134:382-9
pubmed: 444788
Suicide Life Threat Behav. 2011 Feb;41(1):87-97
pubmed: 21309827
BMJ. 2012 Sep 04;345:e5661
pubmed: 22951546
Aust N Z J Psychiatry. 2014 Apr;48(4):360-70
pubmed: 24253359
Suicide Life Threat Behav. 2016 Jun;46(3):352-62
pubmed: 26511788
BMJ. 2013 Jan 08;346:e7586
pubmed: 23303884
Soc Psychiatry Psychiatr Epidemiol. 2017 Mar;52(3):249-258
pubmed: 28144713
J Affect Disord. 2013 Sep 5;150(2):320-9
pubmed: 23706876
J Ment Health. 2012 Oct;21(5):469-77
pubmed: 22978502
J Am Med Inform Assoc. 2004 Nov-Dec;11(6):499-504
pubmed: 15298993
Soc Sci Med. 2005 Oct;61(8):1821-7
pubmed: 16029778
Crisis. 2007;28(2):89-94
pubmed: 17722690
Psychiatry Res. 2011 Jun 30;188(1):58-64
pubmed: 21339006
J Clin Epidemiol. 1998 Nov;51(11):1171-8
pubmed: 9817135
Med Care. 2004 Sep;42(9):851-9
pubmed: 15319610
J Med Internet Res. 2009 Feb 20;11(1):e4
pubmed: 19275980
BMC Health Serv Res. 2008 Dec 23;8:274
pubmed: 19105823
Clin Trials. 2005;2(2):91-8
pubmed: 16279130
J Clin Epidemiol. 2005 Mar;58(3):246-51
pubmed: 15718113