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Accepted for/Published in: Journal of Medical Internet Research

Date Submitted: Dec 9, 2018
Open Peer Review Period: Dec 12, 2018 - Jan 31, 2019
Date Accepted: Mar 24, 2019
(closed for review but you can still tweet)

The final, peer-reviewed published version of this preprint can be found here:

Recruiting to a Randomized Controlled Trial of a Web-Based Program for People With Type 2 Diabetes and Depression: Lessons Learned at the Intersection of e-Mental Health and Primary Care

Fletcher S, Clarke J, Sanatkar S, Baldwin P, Gunn J, Zwar N, Campbell L, Wilhelm K, Harris M, Lapsley H, Hadzi-Pavlovic D, Proudfoot J

Recruiting to a Randomized Controlled Trial of a Web-Based Program for People With Type 2 Diabetes and Depression: Lessons Learned at the Intersection of e-Mental Health and Primary Care

J Med Internet Res 2019;21(5):e12793

DOI: 10.2196/12793

PMID: 31127718

PMCID: 6555119

Recruiting to a randomised controlled trial of an online program for people with type 2 diabetes and depression: Lessons learned at the intersection of e-mental health and primary care

  • Susan Fletcher; 
  • Janine Clarke; 
  • Samineh Sanatkar; 
  • Peter Baldwin; 
  • Jane Gunn; 
  • Nick Zwar; 
  • Lesley Campbell; 
  • Kay Wilhelm; 
  • Mark Harris; 
  • Helen Lapsley; 
  • Dusan Hadzi-Pavlovic; 
  • Judy Proudfoot

ABSTRACT

Background:

e-mental health (eMH) interventions are now widely available and they have the potential to revolutionise the way that health care is delivered. As most health care is currently delivered by primary care, there is enormous potential for eMH interventions to support, or in some cases substitute, for services currently delivered face to face in the community setting. However randomised trials of eMH interventions have tended to recruit participants using online recruitment methods. Consequently, it is difficult to know whether participants recruited online differ from those who attend primary care.

Objective:

This paper aims to document the experience of recruiting to an eMH trial through primary care and compare the characteristics of participants recruited through this and other recruitment methods.

Methods:

Recruitment to the SpringboarD randomised controlled trial was initially focused on general practices in two states of Australia. Over 15 months we employed a comprehensive approach to engaging practice staff and supporting them to recruit patients, including face to face site visits, regular contact via telephone and trial newsletters, and development of an online patient registration portal. Nevertheless, it became apparent that these efforts would not yield the required sample size and we therefore supplemented recruitment through national online advertising and promoting the study through existing networks. Baseline characteristics of participants recruited to the trial through general practice, online, or other sources were compared using ANOVA and chi square.

Results:

Between November 2015 and October 2017, 780 people enrolled in SpringboarD, of whom 740 provided information on recruitment source. Of these, just 24 were recruited through general practice, while 520 were recruited online and 196 through existing networks. Key barriers to general practice recruitment included perceived mismatch between trial design and diabetes population, prioritisation of acute health issues, and disruptions posed by events at the practice and community level. Participants recruited through the three different approaches differed on age, gender, employment status, depressive symptoms and diabetes distress, with participants online distinguished from those recruited through general practice or other sources. However most differences reached only a small effect size and are unlikely to be of clinical importance.

Conclusions:

Time, labour, and cost intensive efforts did not translate into successful recruitment through general practice in this instance, with barriers identified at several different levels. Online recruitment yielded more participants, who were similar to those recruited via general practice. Clinical Trial: ACTRN12615000931572


 Citation

Please cite as:

Fletcher S, Clarke J, Sanatkar S, Baldwin P, Gunn J, Zwar N, Campbell L, Wilhelm K, Harris M, Lapsley H, Hadzi-Pavlovic D, Proudfoot J

Recruiting to a Randomized Controlled Trial of a Web-Based Program for People With Type 2 Diabetes and Depression: Lessons Learned at the Intersection of e-Mental Health and Primary Care

J Med Internet Res 2019;21(5):e12793

DOI: 10.2196/12793

PMID: 31127718

PMCID: 6555119

Per the author's request the PDF is not available.

© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.