Recruitment of men to a multi-centre diabetes prevention trial: an evaluation of traditional and online promotional strategies.


Journal

Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253

Informations de publication

Date de publication:
19 Jun 2019
Historique:
received: 30 10 2018
accepted: 30 05 2019
entrez: 21 6 2019
pubmed: 21 6 2019
medline: 4 1 2020
Statut: epublish

Résumé

Effective interventions are required to prevent the current rapid increase in the prevalence of Type 2 diabetes. Clinical trials of large-scale interventions to prevent Type 2 diabetes are essential but recruitment is challenging and expensive, and there are limited data regarding the most cost-effective and efficient approaches to recruitment. This paper aims to evaluate the cost and effectiveness of a range of promotional strategies used to recruit men to a large Type 2 diabetes prevention trial. An observational study was conducted nested within the Testosterone for the Prevention of Type 2 Diabetes (T4DM) study, a large, multi-centre randomised controlled trial (RCT) of testosterone treatment for the prevention of Type 2 diabetes in men aged 50-74 years at high risk of developing diabetes. Study participation was promoted via mainstream media-television, newspaper and radio; direct marketing using mass mail-outs, publicly displayed posters and attendance at local events; digital platforms, including Facebook and Google; and online promotions by community organisations and businesses. For each strategy, the resulting number of participants and the direct cost involved were recorded. The staff effort required for each strategy was estimated based on feedback from staff. Of 19,022 men screened for the study, 1007 (5%) were enrolled. The most effective recruitment strategies were targeted radio advertising (accounting for 42% of participants), television news coverage (20%) and mass mail-outs (17%). Other strategies, including radio news, publicly displayed posters, attendance at local events, newspaper advertising, online promotions and Google and Facebook advertising, each accounted for no more than 4% of enrolled participants. Recruitment promotions cost an average of AU$594 per randomised participant. The most cost-effective paid strategy was mass mail-outs by a government health agency (AU$745 per participant). Other paid strategies were more expensive: mail-out by general practitioners (GPs) (AU$1104 per participant), radio advertising (AU$1081) and newspaper advertising (AU$1941). Radio advertising, television news coverage and mass mail-outs by a government health agency were the most effective recruitment strategies. Close monitoring of recruitment outcomes and ongoing enhancement of recruitment activities played a central role in recruitment to this RCT. ANZCTR, ID: ACTRN12612000287831 . Registered on 12 March 2012.

Sections du résumé

BACKGROUND BACKGROUND
Effective interventions are required to prevent the current rapid increase in the prevalence of Type 2 diabetes. Clinical trials of large-scale interventions to prevent Type 2 diabetes are essential but recruitment is challenging and expensive, and there are limited data regarding the most cost-effective and efficient approaches to recruitment. This paper aims to evaluate the cost and effectiveness of a range of promotional strategies used to recruit men to a large Type 2 diabetes prevention trial.
METHODS METHODS
An observational study was conducted nested within the Testosterone for the Prevention of Type 2 Diabetes (T4DM) study, a large, multi-centre randomised controlled trial (RCT) of testosterone treatment for the prevention of Type 2 diabetes in men aged 50-74 years at high risk of developing diabetes. Study participation was promoted via mainstream media-television, newspaper and radio; direct marketing using mass mail-outs, publicly displayed posters and attendance at local events; digital platforms, including Facebook and Google; and online promotions by community organisations and businesses. For each strategy, the resulting number of participants and the direct cost involved were recorded. The staff effort required for each strategy was estimated based on feedback from staff.
RESULTS RESULTS
Of 19,022 men screened for the study, 1007 (5%) were enrolled. The most effective recruitment strategies were targeted radio advertising (accounting for 42% of participants), television news coverage (20%) and mass mail-outs (17%). Other strategies, including radio news, publicly displayed posters, attendance at local events, newspaper advertising, online promotions and Google and Facebook advertising, each accounted for no more than 4% of enrolled participants. Recruitment promotions cost an average of AU$594 per randomised participant. The most cost-effective paid strategy was mass mail-outs by a government health agency (AU$745 per participant). Other paid strategies were more expensive: mail-out by general practitioners (GPs) (AU$1104 per participant), radio advertising (AU$1081) and newspaper advertising (AU$1941).
CONCLUSION CONCLUSIONS
Radio advertising, television news coverage and mass mail-outs by a government health agency were the most effective recruitment strategies. Close monitoring of recruitment outcomes and ongoing enhancement of recruitment activities played a central role in recruitment to this RCT.
TRIAL REGISTRATION BACKGROUND
ANZCTR, ID: ACTRN12612000287831 . Registered on 12 March 2012.

Identifiants

pubmed: 31217024
doi: 10.1186/s13063-019-3485-2
pii: 10.1186/s13063-019-3485-2
pmc: PMC6585027
doi:

Substances chimiques

Testosterone 3XMK78S47O

Types de publication

Clinical Trial, Phase III Journal Article Multicenter Study Observational Study Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

366

Subventions

Organisme : National Health and Medical Research Council
ID : APP1030123
Organisme : Bayer HealthCare
ID : N/A
Organisme : Eli Lilly (AU)
ID : N/A
Organisme : University of Adelaide
ID : N/A
Organisme : University of Sydney
ID : N/A

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Auteurs

Karen Bracken (K)

NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia. karen.bracken@ctc.usyd.edu.au.

Wendy Hague (W)

NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.

Anthony Keech (A)

NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.

Ann Conway (A)

Anzac Research Institute, and Andrology Department, Concord Hospital, Sydney, NSW, Australia.

David J Handelsman (DJ)

Anzac Research Institute, and Andrology Department, Concord Hospital, Sydney, NSW, Australia.

Mathis Grossmann (M)

Department of Medicine, the University of Melbourne, and Department of Endocrinology, Austin Health, Melbourne, VIC, Australia.

David Jesudason (D)

Queen Elizabeth Hospital, Adelaide, SA, Australia.

Bronwyn Stuckey (B)

Department of Endocrinology and Diabetes, Keogh Institute of Medical Research, Sir Charles Gairdner Hospital and Medical School, University of Western Australia, Perth, WA, Australia.

Bu B Yeap (BB)

Department of Endocrinology and Diabetes, Medical School, University of Western Australia and Fiona Stanley Hospital, Perth, WA, Australia.

Warrick Inder (W)

Princess Alexandra Hospital, Brisbane, QLD, Australia.

Carolyn Allan (C)

Department of Clinical Research, Hudson Institute of Medical Research, Melbourne, VIC, Australia.

Robert McLachlan (R)

Department of Clinical Research, Hudson Institute of Medical Research, Melbourne, VIC, Australia.

Kristy P Robledo (KP)

NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.

Gary Wittert (G)

Freemasons Foundation Centre for Men's Health, School of Medicine, University of Adelaide, Adelaide, SA, Australia.

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Classifications MeSH