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      Participant Recruitment and Retention in Remote eHealth Intervention Trials: Methods and Lessons Learned From a Large Randomized Controlled Trial of Two Web-Based Smoking Interventions

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          Abstract

          Background

          Despite having many advantages, online eHealth trials are not without challenges—notably, participant recruitment, and outcome data retention. Moreover, publications from these trials rarely provide detailed information on the methods used for recruitment and retention or discuss implications of the methods for future studies.

          Objective

          To address this need for empirical guidance regarding recruitment and outcome data retention planning, we aim to describe the methods and lessons learned from the recruitment and retention procedures used in a large randomized trial of 2 Web-based smoking cessation interventions.

          Methods

          To ensure a demographically and geographically diverse participant sample, we used the recruitment strategies (1) traditional, (2) Web-based, and (3) online survey panel methods and adaptively modified each in response to recruitment success. At baseline, participants indicated how they heard about the study and answered demographic questions. To maximize trial retention at each of the 3-, 6-, and 12-month assessment points, 4 survey modalities (first Web, followed by phone, mail, and postcard) were sequentially timed over a 30-day period. Participants received US $25 for submitting their responses, regardless of modality, and received an additional US $10 bonus for completing the Web survey within 24h of electronic notification.

          Results

          We randomized 2637 smokers in 16 months and achieved 88% retention at 12-months. Participants (79.26% female, 72.60% Caucasian) were recruited from all 50 states. The majority of participants were recruited through Facebook (49.43%), followed by the survey panel (20.85%), free internet sources (14.54%), traditional media (11.34%), and Google ads (3.84%). Descriptively, participant demographics varied by recruitment source. Of the completed follow-up surveys, most were completed by Web (92%). Retention rates did not vary by recruitment source.

          Conclusions

          Continuous monitoring and refinement of multiple recruitment methods, particularly of online advertising campaigns, allowed us to maximize the effectiveness of recruitment strategies in recruiting a large, diverse sample of smokers. Likewise, offering multiple follow-up survey modalities in sequential order along with time-dependent bonus incentives enabled us to obtain outcome data from a very high level of enrolled participants for the duration of the trial protocol. These strategies may be similarly useful in other trials.

          Trial Registration

          ClinicalTrials.gov NCT01812278; https://clinicaltrials.gov/ct2/show/NCT01812278 (Archived by WebCite at http://www.webcitation.org/71gy5GLvO)

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          Most cited references38

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          Controlling the False Discovery Rate: A Practical and Powerful Approach to Multiple Testing

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            Dropout from Internet-based treatment for psychological disorders.

            The purpose of this review was to present an in-depth analysis of literature identifying the extent of dropout from Internet-based treatment programmes for psychological disorders, and literature exploring the variables associated with dropout from such programmes. A comprehensive literature search was conducted on PSYCHINFO and PUBMED with the keywords: dropouts, drop out, dropout, dropping out, attrition, premature termination, termination, non-compliance, treatment, intervention, and program, each in combination with the key words Internet and web. A total of 19 studies published between 1990 and April 2009 and focusing on dropout from Internet-based treatment programmes involving minimal therapist contact were identified and included in the review. Dropout ranged from 2 to 83% and a weighted average of 31% of the participants dropped out of treatment. A range of variables have been examined for their association with dropout from Internet-based treatment programmes for psychological disorders. Despite the numerous variables explored, evidence on any specific variables that may make an individual more likely to drop out of Internet-based treatment is currently limited. This review highlights the need for more rigorous and theoretically guided research exploring the variables associated with dropping out of Internet-based treatment for psychological disorders.
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              A reinvestigation of recruitment to randomised, controlled, multicenter trials: a review of trials funded by two UK funding agencies

              Background Randomised controlled trials (RCTs) are the gold standard assessment for health technologies. A key aspect of the design of any clinical trial is the target sample size. However, many publicly-funded trials fail to reach their target sample size. This study seeks to assess the current state of recruitment success and grant extensions in trials funded by the Health Technology Assessment (HTA) program and the UK Medical Research Council (MRC). Methods Data were gathered from two sources: the National Institute for Health Research (NIHR) HTA Journal Archive and the MRC subset of the International Standard Randomised Controlled Trial Number (ISRCTN) register. A total of 440 trials recruiting between 2002 and 2008 were assessed for eligibility, of which 73 met the inclusion criteria. Where data were unavailable from the reports, members of the trial team were contacted to ensure completeness. Results Over half (55%) of trials recruited their originally specified target sample size, with over three-quarters (78%) recruiting 80% of their target. There was no evidence of this improving over the time of the assessment. Nearly half (45%) of trials received an extension of some kind. Those that did were no more likely to successfully recruit. Trials with 80% power were less likely to successfully recruit compared to studies with 90% power. Conclusions While recruitment appears to have improved since 1994 to 2002, publicly-funded trials in the UK still struggle to recruit to their target sample size, and both time and financial extensions are often requested. Strategies to cope with such problems should be more widely applied. It is recommended that where possible studies are planned with 90% power.
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                Author and article information

                Contributors
                Journal
                J Med Internet Res
                J. Med. Internet Res
                JMIR
                Journal of Medical Internet Research
                JMIR Publications (Toronto, Canada )
                1439-4456
                1438-8871
                August 2018
                24 August 2018
                : 20
                : 8
                : e10351
                Affiliations
                [1] 1 Fred Hutchinson Cancer Research Center Seattle, WA United States
                [2] 2 Kaiser Permanente Washington Health Research Institute Seattle, WA United States
                [3] 3 University of Washington Seattle, WA United States
                Author notes
                Corresponding Author: Noreen L Watson nlwatson@ 123456fredhutch.org
                Author information
                http://orcid.org/0000-0002-4563-0239
                http://orcid.org/0000-0002-7918-3078
                http://orcid.org/0000-0001-9604-5489
                http://orcid.org/0000-0002-2094-9147
                http://orcid.org/0000-0002-5694-8795
                Article
                v20i8e10351
                10.2196/10351
                6128955
                30143479
                63fcb9fe-ef04-4be1-b278-7f094e5ba5ff
                ©Noreen L Watson, Kristin E Mull, Jaimee L Heffner, Jennifer B McClure, Jonathan B Bricker. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 24.08.2018.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research, is properly cited. The complete bibliographic information, a link to the original publication on http://www.jmir.org/.as well as this copyright and license information must be included.

                History
                : 8 March 2018
                : 29 March 2018
                : 25 July 2018
                : 1 August 2018
                Categories
                Original Paper
                Original Paper

                Medicine
                recruitment,retention,randomized controlled trial,rct,smoking cessation,web intervention
                Medicine
                recruitment, retention, randomized controlled trial, rct, smoking cessation, web intervention

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