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

Noreen L Watson, Kristin E Mull, Jaimee L Heffner, Jennifer B McClure, Jonathan B Bricker, Noreen L Watson, Kristin E Mull, Jaimee L Heffner, Jennifer B McClure, Jonathan B Bricker

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://ichgcp.net/clinical-trials-registry/NCT01812278 (Archived by WebCite at http://www.webcitation.org/71gy5GLvO).

Keywords: RCT; randomized controlled trial; recruitment; retention; smoking cessation; web intervention.

Conflict of interest statement

Conflicts of Interest: In July 2016, JBB was a consultant to Glaxo Smith Kline, the makers of a nicotine replacement therapy. He now serves on the Scientific Advisory Board of Chrono Therapeutics, the makers of a nicotine replacement therapy device. JLH has received research support from Pfizer, the makers of a smoking cessation medication. Other authors have no declarations.

©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.

Figures

Figure 1
Figure 1
Content used for general Craigslist advertisements.
Figure 2
Figure 2
Example Facebook ad with image.
Figure 3
Figure 3
Geographic location of participants from all 50 states; each participant is represented by a single dot.

References

    1. Poushter Jacob. Pew Research Center. Pew Research Center; 2016. Feb 22, [2018-08-16]. Smartphone Ownership and Internet Usage Continues to Climb in Emerging Economies
    1. Murray E, Khadjesari Z, White IR, Kalaitzaki E, Godfrey C, McCambridge J, Thompson SG, Wallace P. Methodological challenges in online trials. J Med Internet Res. 2009;11(2):e9. doi: 10.2196/jmir.1052.
    1. Anguera JA, Jordan JT, Castaneda D, Gazzaley A, Areán PA. Conducting a fully mobile and randomised clinical trial for depression: access, engagement and expense. BMJ Innov. 2016 Jan;2(1):14–21. doi: 10.1136/bmjinnov-2015-000098.
    1. Kasenda B, von EE, You J, Blümle A, Tomonaga Y, Saccilotto R, Amstutz A, Bengough T, Meerpohl JJ, Stegert M, Tikkinen KAO, Neumann I, Carrasco-Labra A, Faulhaber M, Mulla SM, Mertz D, Akl EA, Bassler D, Busse JW, Ferreira-González I, Lamontagne F, Nordmann A, Gloy V, Raatz H, Moja L, Rosenthal R, Ebrahim S, Schandelmaier S, Xin S, Vandvik PO, Johnston BC, Walter MA, Burnand B, Schwenkglenks M, Hemkens LG, Bucher HC, Guyatt GH, Briel M. Prevalence, characteristics, and publication of discontinued randomized trials. JAMA. 2014 Mar 12;311(10):1045–51. doi: 10.1001/jama.2014.1361.
    1. Gul RB, Ali PA. Clinical trials: the challenge of recruitment and retention of participants. J Clin Nurs. 2010 Jan;19(1-2):227–33. doi: 10.1111/j.1365-2702.2009.03041.x.
    1. Danaher BG, Seeley JR. Methodological issues in research on web-based behavioral interventions. Ann Behav Med. 2009 Aug;38(1):28–39. doi: 10.1007/s12160-009-9129-0.
    1. Haines-Saah RJ, Kelly MT, Oliffe JL, Bottorff JL. Picture Me Smokefree: a qualitative study using social media and digital photography to engage young adults in tobacco reduction and cessation. J Med Internet Res. 2015;17(1):e27. doi: 10.2196/jmir.4061.
    1. Powell J, Newhouse N, Martin A, Jawad S, Yu L, Davoudianfar M, Locock L, Ziebland S. A novel experience-based internet intervention for smoking cessation: feasibility randomised controlled trial. BMC Public Health. 2016 Dec 11;16(1):1156. doi: 10.1186/s12889-016-3821-3.
    1. van Spijker BA, Werner-Seidler A, Batterham PJ, Mackinnon A, Calear AL, Gosling JA, Reynolds J, Kerkhof AJ, Solomon D, Shand F, Christensen H. Effectiveness of a Web-Based Self-Help Program for Suicidal Thinking in an Australian Community Sample: Randomized Controlled Trial. J Med Internet Res. 2018 Feb 14;20(2):e15. doi: 10.2196/jmir.8595.
    1. Carter-Harris L, Bartlett ER, Warrick A, Rawl S. Beyond Traditional Newspaper Advertisement: Leveraging Facebook-Targeted Advertisement to Recruit Long-Term Smokers for Research. J Med Internet Res. 2016;18(6):e117. doi: 10.2196/jmir.5502.
    1. Topolovec-Vranic J, Natarajan K. The Use of Social Media in Recruitment for Medical Research Studies: A Scoping Review. J Med Internet Res. 2016 Nov 7;18(11):e286. doi: 10.2196/jmir.5698.
    1. Thornton L, Batterham PJ, Fassnacht DB, Kay-Lambkin F, Calear AL, Hunt S. Recruiting for health, medical or psychosocial research using Facebook: Systematic review. Internet Interventions. 2016 May;4:72–81. doi: 10.1016/j.invent.2016.02.001.
    1. Sully BGO, Julious SA, Nicholl J. A reinvestigation of recruitment to randomised, controlled, multicenter trials: a review of trials funded by two UK funding agencies. Trials. 2013;14:166. doi: 10.1186/1745-6215-14-166.
    1. Carlisle B, Kimmelman J, Ramsay T, MacKinnon N. Unsuccessful trial accrual and human subjects protections: an empirical analysis of recently closed trials. Clin Trials. 2015 Feb;12(1):77–83. doi: 10.1177/1740774514558307.
    1. Pica N, Bourgeois F. Discontinuation and Nonpublication of Randomized Clinical Trials Conducted in Children. Pediatrics. 2016 Sep;138(3):1–11. doi: 10.1542/peds.2016-0223.
    1. Arean PA, Hallgren KA, Jordan JT, Gazzaley A, Atkins DC, Heagerty PJ, Anguera JA. The Use and Effectiveness of Mobile Apps for Depression: Results From a Fully Remote Clinical Trial. J Med Internet Res. 2016 Dec 20;18(12):e330. doi: 10.2196/jmir.6482.
    1. Eysenbach G. The law of attrition. J Med Internet Res. 2005;7(1):e11. doi: 10.2196/jmir.7.1.e11.
    1. Melville KM, Casey LM, Kavanagh DJ. Dropout from Internet-based treatment for psychological disorders. Br J Clin Psychol. 2010 Nov;49(Pt 4):455–71. doi: 10.1348/014466509X472138.
    1. Riper H, Kramer J, Smit F, Conijn B, Schippers G, Cuijpers P. Web-based self-help for problem drinkers: a pragmatic randomized trial. Addiction. 2008 Feb;103(2):218–27. doi: 10.1111/j.1360-0443.2007.02063.x.
    1. Fewtrell MS, Kennedy K, Singhal A, Martin RM, Ness A, Hadders-Algra M, Koletzko B, Lucas A. How much loss to follow-up is acceptable in long-term randomised trials and prospective studies? Arch Dis Child. 2008 Jun;93(6):458–61. doi: 10.1136/adc.2007.127316.
    1. Hall SM, Delucchi KL, Velicer WF, Kahler CW, Ranger-Moore J, Hedeker D, Tsoh JY, Niaura R. Statistical analysis of randomized trials in tobacco treatment: longitudinal designs with dichotomous outcome. Nicotine Tob Res. 2001 Aug;3(3):193–202. doi: 10.1080/14622200110050411.
    1. Gordon JS, Akers L, Severson HH, Danaher BG, Boles SM. Successful participant recruitment strategies for an online smokeless tobacco cessation program. Nicotine Tob Res. 2006 Dec;8 Suppl 1:S35–41.
    1. Sandy M, Butler A. Microbial iron acquisition: marine and terrestrial siderophores. Chem Rev. 2009 Oct;109(10):4580–95. doi: 10.1021/cr9002787.
    1. Ritterband LM, Thorndike FP, Ingersoll KS, Lord HR, Gonder-Frederick L, Frederick C, Quigg MS, Cohn WF, Morin CM. Effect of a Web-Based Cognitive Behavior Therapy for Insomnia Intervention With 1-Year Follow-up: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Jan 01;74(1):68–75. doi: 10.1001/jamapsychiatry.2016.3249.
    1. Squiers L, Brown D, Parvanta S, Dolina S, Kelly B, Dever J, Southwell BG, Sanders A, Augustson E. The SmokefreeTXT (SFTXT) Study: Web and Mobile Data Collection to Evaluate Smoking Cessation for Young Adults. JMIR Res Protoc. 2016 Jun 27;5(2):e134. doi: 10.2196/resprot.5653.
    1. Geraghty AWA, Torres LD, Leykin Y, Pérez-Stable EJ, Muñoz RF. Understanding attrition from international Internet health interventions: a step towards global eHealth. Health Promot Int. 2013 Sep;28(3):442–52. doi: 10.1093/heapro/das029.
    1. Choi SH, Mitchell J, Lipkus I. Lessons Learned From an Online Study with Dual-smoker Couples. Am J Health Behav. 2017 Jan;41(1):61–66.
    1. Lane TS, Armin J, Gordon JS. Online Recruitment Methods for Web-Based and Mobile Health Studies: A Review of the Literature. J Med Internet Res. 2015;17(7):e183. doi: 10.2196/jmir.4359.
    1. Bricker JB, Mull KE, McClure JB, Watson NL, Heffner JL. Improving quit rates of web-delivered interventions for smoking cessation: full-scale randomized trial of versus . Addiction. 2017 Dec 13;:914–923. doi: 10.1111/add.14127.
    1. Bricker J, Wyszynski C, Comstock B, Heffner JL. Pilot randomized controlled trial of web-based acceptance and commitment therapy for smoking cessation. Nicotine Tob Res. 2013 Oct;15(10):1756–64. doi: 10.1093/ntr/ntt056.
    1. Nguyen K, Marshall L, Hu S, Neff L. State-specific prevalence of current cigarette smoking and smokeless tobacco use among adults aged ≥ 18 years--United States, 2011-2013. Morbidity and Mortality Weekly Report. 2015;64(19):532–536.
    1. The Daily Beast. 2011. Jan 03, [2018-08-16]. 30 cities with worst smoking problems, from Memphis to Honolulu .
    1. Survey Sampling International. [2018-06-22].
    1. Brodar KE, Hall MG, Butler EN, Parada H, Stein-Seroussi A, Hanley S, Brewer NT. Recruiting Diverse Smokers: Enrollment Yields and Cost. Int J Environ Res Public Health. 2016 Dec 16;13(12):1–9. doi: 10.3390/ijerph13121251.
    1. Frandsen M, Thow M, Ferguson SG. The Effectiveness Of Social Media (Facebook) Compared With More Traditional Advertising Methods for Recruiting Eligible Participants To Health Research Studies: A Randomized, Controlled Clinical Trial. JMIR Res Protoc. 2016;5(3):e161. doi: 10.2196/resprot.5747.
    1. Radloff LS. The CES-D Scale: A Self-Report Depression Scale for Research in the General Population. Applied Psychological Measurement. 1977 Jun 01;1(3):385–401. doi: 10.1177/014662167700100306.
    1. Spitzer RL, Kroenke K, Williams JBW, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092–7. doi: 10.1001/archinte.166.10.1092.
    1. Stein MB, Roy-Byrne PP, McQuaid JR, Laffaye C, Russo J, McCahill ME, Katon W, Craske M, Bystritsky A, Sherbourne CD. Development of a brief diagnostic screen for panic disorder in primary care. Psychosom Med. 1999;61(3):359–64.
    1. Lang AJ, Wilkins K, Roy-Byrne PP, Golinelli D, Chavira D, Sherbourne C, Rose RD, Bystritsky A, Sullivan G, Craske MG, Stein MB. Abbreviated PTSD Checklist (PCL) as a guide to clinical response. Gen Hosp Psychiatry. 2012;34(4):332–8. doi: 10.1016/j.genhosppsych.2012.02.003.
    1. Connor KM, Kobak KA, Churchill LE, Katzelnick D, Davidson JR. Mini-SPIN: A brief screening assessment for generalized social anxiety disorder. Depress Anxiety. 2001;14(2):137–40.
    1. United States Department of Agriculture. [2018-06-22]. Rural-Urban Commuting Area Codes .
    1. Dillman DA, Phelps G, Tortora R, Swift K, Kohrell J, Berck J, Messer BL. Response rate and measurement differences in mixed-mode surveys using mail, telephone, interactive voice response (IVR) and the Internet. Social Science Research. 2009 Mar;38(1):1–18. doi: 10.1016/j.ssresearch.2008.03.007.
    1. Benjamini Y, Hochberg Y. Controlling the false discovery rate: A practicalpowerful approach to multiple testing. Journal of the Royal Statistics Society B. 1995;57(1):289–300.
    1. Graham AL, Milner P, Saul JE, Pfaff L. Online advertising as a public health and recruitment tool: comparison of different media campaigns to increase demand for smoking cessation interventions. J Med Internet Res. 2008;10(5):e50. doi: 10.2196/jmir.1001.
    1. Laws RA, Litterbach EV, Denney-Wilson EA, Russell CG, Taki S, Ong K, Elliott RM, Lymer SJ, Campbell KJ. A Comparison of Recruitment Methods for an mHealth Intervention Targeting Mothers: Lessons from the Growing Healthy Program. J Med Internet Res. 2016 Sep 15;18(9):e248. doi: 10.2196/jmir.5691.
    1. Lindner P, Nyström MB, Hassmén P, Andersson G, Carlbring P. Who seeks ICBT for depression and how do they get there? Effects of recruitment source on patient demographics and clinical characteristics. Internet Interventions. 2015 May;2(2):221–225. doi: 10.1016/j.invent.2015.04.002.
    1. Morgan AJ, Jorm AF, Mackinnon AJ. Internet-based recruitment to a depression prevention intervention: lessons from the Mood Memos study. J Med Internet Res. 2013;15(2):e31. doi: 10.2196/jmir.2262.
    1. Gross MS, Liu NH, Contreras O, Muñoz RF, Leykin Y. Using Google AdWords for international multilingual recruitment to health research websites. J Med Internet Res. 2014 Jan 20;16(1):e18. doi: 10.2196/jmir.2986.
    1. Prescott TL, Phillips IG, DuBois LZ, Bull SS, Mustanski B, Ybarra ML. Reaching Adolescent Gay, Bisexual, and Queer Men Online: Development and Refinement of a National Recruitment Strategy. J Med Internet Res. 2016;18(8):e200. doi: 10.2196/jmir.5602.
    1. Whitaker C, Stevelink S, Fear N. The Use of Facebook in Recruiting Participants for Health Research Purposes: A Systematic Review. J Med Internet Res. 2017 Aug 28;19(8):e290. doi: 10.2196/jmir.7071.
    1. Guillory J, Wiant KF, Farrelly M, Fiacco L, Alam I, Hoffman L, Crankshaw E, Delahanty J, Alexander TN. Recruiting Hard-to-Reach Populations for Survey Research: Using Facebook and Instagram Advertisements and In-Person Intercept in LGBT Bars and Nightclubs to Recruit LGBT Young Adults. J Med Internet Res. 2018 Jun 18;20(6):e197. doi: 10.2196/jmir.9461.
    1. Cowie JM, Gurney ME. The Use of Facebook Advertising to Recruit Healthy Elderly People for a Clinical Trial: Baseline Metrics. JMIR Res Protoc. 2018 Jan 24;7(1):e20. doi: 10.2196/resprot.7918.
    1. United States Census Bureau. 2016. Dec 08, [2018-08-16]. New Census Data Show Differences Between Urban and Rural Populations .
    1. Reiter PL, Katz ML, Bauermeister JA, Shoben AB, Paskett ED, McRee A. Recruiting Young Gay and Bisexual Men for a Human Papillomavirus Vaccination Intervention Through Social Media: The Effects of Advertisement Content. JMIR Public Health Surveill. 2017 Jun 02;3(2):e33. doi: 10.2196/publichealth.7545.
    1. Abroms LC, Boal AL, Simmens SJ, Mendel JA, Windsor RA. A randomized trial of Text2Quit: a text messaging program for smoking cessation. Am J Prev Med. 2014 Sep;47(3):242–50. doi: 10.1016/j.amepre.2014.04.010.
    1. Bricker JB, Copeland W, Mull KE, Zeng EY, Watson NL, Akioka KJ, Heffner JL. Single-arm trial of the second version of an acceptance & commitment therapy smartphone application for smoking cessation. Drug Alcohol Depend. 2016 Nov 04;170:37–42. doi: 10.1016/j.drugalcdep.2016.10.029.
    1. Christoforou M, Sáez FJA, Tsakanikos E. Two Novel Cognitive Behavioral Therapy-Based Mobile Apps for Agoraphobia: Randomized Controlled Trial. J Med Internet Res. 2017 Nov 24;19(11):e398. doi: 10.2196/jmir.7747.
    1. Cha S, Erar B, Niaura RS, Graham AL. Baseline Characteristics and Generalizability of Participants in an Internet Smoking Cessation Randomized Trial. Ann Behav Med. 2016 Oct;50(5):751–761. doi: 10.1007/s12160-016-9804-x.
    1. Kontos E, Blake KD, Chou WS, Prestin A. Predictors of eHealth usage: insights on the digital divide from the Health Information National Trends Survey 2012. J Med Internet Res. 2014;16(7):e172. doi: 10.2196/jmir.3117.
    1. Murray E, White IR, Varagunam M, Godfrey C, Khadjesari Z, McCambridge J. Attrition revisited: adherence and retention in a web-based alcohol trial. J Med Internet Res. 2013;15(8):e162. doi: 10.2196/jmir.2336.
    1. Jahangiry L, Shojaeizadeh D, Montazeri A, Najafi M, Mohammad K, Yaseri M. Adherence and Attrition in a Web-Based Lifestyle Intervention for People with Metabolic Syndrome. Iran J Public Health. 2014;43(9):1248–58.

Source: PubMed

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