Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2020

Open Access 01-12-2020 | Tic Disorder | Research

Opportunities and challenges of delivering digital clinical trials: lessons learned from a randomised controlled trial of an online behavioural intervention for children and young people

Authors: Charlotte L. Hall, Charlotte Sanderson, Beverly J. Brown, Per Andrén, Sophie Bennett, Liam R. Chamberlain, E. Bethan Davies, Kareem Khan, Natalie Kouzoupi, David Mataix-Cols, Caitlin McKenzie, Tara Murphy, Mark Townsend, Chris Hollis, Elizabeth Murray

Published in: Trials | Issue 1/2020

Login to get access

Abstract

Background

Despite being the gold standard of research to determine effectiveness, randomised controlled trials (RCTs) often struggle with participant recruitment, engagement and retention. These issues may be exacerbated when recruiting vulnerable populations, such as participants with mental health issues. We aimed to update understanding of the scope of these problems in trials of health technology and identify possible solutions through reflecting on experiences from an exemplar trial (Online Remote Behavioural Intervention for Tics; ORBIT).

Method

We extracted anonymised data on recruitment, retention and requests for more funding and time from trials funded by the largest funder of health technology trials in the UK (the National Institute of Health Research Health Technology Assessment) between 2010 and 2020, and compared these with data from a recent, successful trial (ORBIT). ORBIT aimed to assess the clinical- and cost-effectiveness of blended online and human behavioural therapy for tics in young people. Many of the trial procedures, including recruitment, the intervention and data collection, were undertaken online.

Results

Data were extracted on 51 trials conducted between 2010 and 2020. Sixty per cent of trials failed to reach their original recruitment target and only 44% achieved their follow-up in the specified time frame. In contrast, ORBIT recruited to target and achieved 90% follow-up. We posit that these achievements are related to (a) judicious use of digital technology for trial procedures and (b) adequate numbers of highly trained and motivated trial staff. We provide details of both these to help other research teams plan and cost for successful trials.

Conclusion

An approach combining human and online methods may be advantageous in facilitating trial delivery, particularly in paediatric mental health services. Given the importance of successful clinical trials in advancing healthcare delivery and the waste of human and economic resources associated with unsuccessfully delivered trials, it is imperative that trials are appropriately costed and future research focusses on improving trial design and delivery.

Trial registration

The ORBIT trial is registered with ISRTCN (ISRCTN70758207) Registered on March 20, 2018. and ClinicalTrials.gov (NCT03483493). Registered on March 30, 2018.
Literature
1.
2.
Harbour R, Lowe G, Twaddle S. Scottish intercollegiate guidelines network: the first 15 years (1993-2008). J R Coll Physicians Edinb. 2011;41(2):163–8.PubMedCrossRef
3.
4.
5.
Donovan JL, Rooshenas L, Jepson M, Elliott D, Wade J, Avery K, Mills N, Wilson C, Paramasivan S, Blazeby JM. Optimising recruitment and informed consent in randomised controlled trials: the development and implementation of the Quintet Recruitment Intervention (QRI). Trials. 2016;17(1):283.PubMedPubMedCentralCrossRef
6.
Kasenda B, Von Elm E, You J, Blümle A, Tomonaga Y, Saccilotto R, Amstutz A, Bengough T, Meerpohl JJ, Stegert M. Prevalence, characteristics, and publication of discontinued randomized trials. JAMA. 2014;311(10):1045–52.PubMedCrossRef
7.
Briel M, Speich B, von Elm E, Gloy V. Comparison of randomized controlled trials discontinued or revised for poor recruitment and completed trials with the same research question: a matched qualitative study. Trials. 2019;20(1):800.PubMedPubMedCentralCrossRef
8.
Williams RJ, Tse T, DiPiazza K, Zarin DA. Terminated trials in the ClinicalTrials. gov results database: evaluation of availability of primary outcome data and reasons for termination. PLoS One. 2015;10(5):e0127242.PubMedPubMedCentralCrossRef
9.
Campbell MK, Snowdon C, Francis D, Elbourne DR, McDonald AM, Knight RC, Entwistle V, Garcia J, Roberts I, Grant AM. Recruitment to randomised trials: strategies for trial enrolment and participation study. The STEPS study. Health Tech Assessment. 2007;11(iii):ix–105.
10.
Huang GD, Bull J, McKee KJ, Mahon E, Harper B, Roberts JN. Clinical trials recruitment planning: a proposed framework from the clinical trials transformation initiative. Contemp Clin Trials. 2018;66:74–9.PubMedCrossRef
11.
Treweek S, Lockhart P, Pitkethly M, Cook JA, Kjeldstrøm M, Johansen M, Taskila TK, Sullivan FM, Wilson S, Jackson C. Methods to improve recruitment to randomised controlled trials: Cochrane systematic review and meta-analysis. BMJ Open. 2013;3(2):e002360.PubMedPubMedCentralCrossRef
12.
Gkioni E, Rius R, Dodd S, Gamble C. A systematic review describes models for recruitment prediction at the design stage of a clinical trial. J Clin Epidemiol. 2019;115:141–9.PubMedCrossRef
13.
Walters SJ, dos Anjos Henriques-Cadby IB, Bortolami O, Flight L, Hind D, Jacques RM, Knox C, Nadin B, Rothwell J, Surtees M. Recruitment and retention of participants in randomised controlled trials: a review of trials funded and published by the United Kingdom Health Technology Assessment Programme. BMJ Open. 2017;7(3):e015276.PubMedPubMedCentralCrossRef
14.
Watson NL, Mull KE, Heffner JL, McClure JB, Bricker JB. 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. JMIR. 2018;20(8):e10351.PubMed
15.
Metse AP, Stockings E, Bailey J, Regan T, Bartlem K, Wolfenden L, Taylor G, Wiggers J, Bowman J. Rates of retention of persons with a mental health disorder in outpatient smoking cessation and reduction trials, and associated factors: protocol for a systematic review and meta-analysis. BMJ Open. 2019;9(9):e030646.PubMedPubMedCentralCrossRef
16.
17.
18.
Naidoo N, Ravaud P, Young B, Amiel P, Schanté D, Clarke M, Boutron I. The research burden of randomized controlled trial participation: a systematic thematic synthesis of qualitative evidence. BMC Med. 2020;18(1):6.PubMedPubMedCentralCrossRef
19.
Fisher L, Hessler D, Naranjo D, Polonsky W. AASAP: a program to increase recruitment and retention in clinical trials. Patient Educ Couns. 2012;86(3):372–7.PubMedCrossRef
20.
Abshire M, Dinglas VD, Cajita MIA, Eakin MN, Needham DM, Himmelfarb CD. Participant retention practices in longitudinal clinical research studies with high retention rates. BMC Med Res Methodol. 2017;17(1):30.PubMedPubMedCentralCrossRef
21.
Barak A. Psychological applications on the Internet: a discipline on the threshold of a new millennium. Appl Prev Psychol. 1999;8(4):231–45.CrossRef
22.
Koneska E, Appelbe D, Williamson PR, Dodd S. Usage metrics of web-based interventions evaluated in randomized controlled trials: systematic review. J Med Internet Res. 2020;22(4):e15474.PubMedPubMedCentralCrossRef
23.
Murray E, Hekler EB, Andersson G, Collins LM, Doherty A, Hollis C, Rivera DE, West R, Wyatt JC. Evaluating digital health interventions: key questions and approaches. Am J Prev Med. 2016;51(5):843–51.PubMedPubMedCentralCrossRef
24.
Murray E, Khadjesari Z, White I, Kalaitzaki E, Godfrey C, McCambridge J, Thompson S, Wallace P. Methodological challenges in online trials. J Med Int Res. 2009;11(2):e9.
25.
Aspvall K, Lenhard F, Melin K, Krebs G, Norlin L, Näsström K, Jassi A, Turner C, Knoetze E, Serlachius E. Implementation of internet-delivered cognitive behaviour therapy for pediatric obsessive-compulsive disorder: lessons from clinics in Sweden, United Kingdom and Australia. Internet Interv. 2020;20:100308.PubMedPubMedCentralCrossRef
26.
O’Connor S, Hanlon P, O’Donnell CA, Garcia S, Glanville J, Mair FS. Understanding factors affecting patient and public engagement and recruitment to digital health interventions: a systematic review of qualitative studies. BMC Med Inform Decis Mak. 2016;16(1):120.PubMedPubMedCentralCrossRef
27.
Lillevoll KR, Vangberg HCB, Griffiths KM, Eisemann MR. Uptake and adherence of a self-directed internet-based mental health intervention with tailored e-mail reminders in senior high schools in Norway. BMC Psychiatry. 2014;14(1):14.PubMedPubMedCentralCrossRef
28.
Owen JE, Jaworski BK, Kuhn E, Makin-Byrd KN, Ramsey KM, Hoffman JE. mHealth in the wild: using novel data to examine the reach, use, and impact of PTSD coach. JMIR Ment Health. 2015;2(1):e7.PubMedPubMedCentralCrossRef
29.
Zanaboni P, Ngangue P, Mbemba GIC, Schopf TR, Bergmo TS, Gagnon M-P. Methods to evaluate the effects of internet-based digital health interventions for citizens: systematic review of reviews. J Med Internet Res. 2018;20(6):e10202.PubMedPubMedCentralCrossRef
30.
Hall C, Davies E, Andrén P, Murphy T, Bennett S, Brown B, Brown S, Chamberlain L, Craven M, Evans A, et al. Investigating a therapist-guided, parent-assisted remote digital behavioural intervention for tics in children and adolescents—‘Online Remote Behavioural Intervention for Tics’ (ORBIT) trial: protocol of an internal pilot study and single-blind randomised controlled trial. BMJ Open. 2019;9(1):e027583.PubMedPubMedCentralCrossRef
31.
32.
33.
Zivetz L. The ICD-10 Classification of Mental and Behavioural Disorders: Clinical Descriptions and Diagnostic Guidelines, vol. 1: World Health Organization 1992; 67(30): 227.
34.
Cuenca J, Glazebrook C, Kendall T, Hedderly T, Heyman I, Jackson G, Murphy T, Rickards H, Robertson M, Stern J, Trayner P, Hollis C. Perceptions of treatment for tics among young people with Tourette syndrome and their parents: a mixed methods study. BMC Psychiatry. 2015;15(1):46.PubMedPubMedCentralCrossRef
35.
Khadjesari Z, Murray E, Kalaitzaki E, White IR, McCambridge J, Thompson SG, Wallace P, Godfrey C. Impact and costs of incentives to reduce attrition in online trials: two randomized controlled trials. J Med Internet Res. 2011;13(1):e26.PubMedPubMedCentralCrossRef
36.
Andrén P, Aspvall K, de la Cruz LF, Wiktor P, Romano S, Andersson E, Murphy T, Isomura K, Serlachius E, Mataix-Cols D. Therapist-guided and parent-guided internet-delivered behaviour therapy for paediatric Tourette’s disorder: a pilot randomised controlled trial with long-term follow-up. BMJ Open. 2019;9(2):e024685.PubMedPubMedCentralCrossRef
37.
Piacentini J, Woods DW, Scahill L, Wilhelm S, Peterson AL, Chang S, Ginsburg GS, Deckersbach T, Dziura J, Levi-Pearl S. Behavior therapy for children with Tourette disorder: a randomized controlled trial. JAMA. 2010;303(19):1929–37.PubMedPubMedCentralCrossRef
38.
39.
Khan K, Hollis C, Hall CL, Davies EB, Mataix-Cols D, Andrén P, Murphy T, Brown BJ, Murray E, Glazebrook C. Protocol for the Process Evaluation of the Online Remote Behavioural Intervention for Tics (ORBIT) randomized controlled trial for children and young people. Trials. 2020;21(1):1–10.CrossRef
40.
Cosgrove V, Gliddon E, Berk L, Grimm D, Lauder S, Dodd S, Berk M, Suppes T. Online ethics. where will the interface of mental health and the internet lead us? Int J Bipolar Disord. 2017;5(1):26.PubMedPubMedCentralCrossRef
41.
Sanderson C, Kouzoupi N, Hall CL. Technology matters: the human touch in a digital age–a blended approach in mental healthcare delivery with children and young people. Child Adolesc Mental Health. 2020;26(2):120–2.CrossRef
42.
Jackson M, Berman N, Huber M, Snetselaar L, Granek I, Boe K, Milas C, Spivak J, Chlebowski RT. Research staff turnover and participant adherence in the Women’s Health Initiative. Control Clin Trials. 2003;24(4):422–35.PubMedCrossRef
43.
Beatty L, Binnion C. A systematic review of predictors of, and reasons for, adherence to online psychological interventions. Int J Behav Med. 2016;23:776–94.PubMedCrossRef
44.
Vernmark K, Hesser H, Topooco N, Berger T, Riper H, Luuk L, Backlund L, Carlbring P, Andersson G. Working alliance as a predictor of change in depression during blended cognitive behaviour therapy. Cogn Behav Ther. 2019;48(4):285–99.PubMedCrossRef
Metadata
Title
Opportunities and challenges of delivering digital clinical trials: lessons learned from a randomised controlled trial of an online behavioural intervention for children and young people
Authors
Charlotte L. Hall
Charlotte Sanderson
Beverly J. Brown
Per Andrén
Sophie Bennett
Liam R. Chamberlain
E. Bethan Davies
Kareem Khan
Natalie Kouzoupi
David Mataix-Cols
Caitlin McKenzie
Tara Murphy
Mark Townsend
Chris Hollis
Elizabeth Murray
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-04902-1

Other articles of this Issue 1/2020

Trials 1/2020 Go to the issue

Study protocol

Protocol for a randomized controlled trial to assess two procedures of vaginal native tissue repair for pelvic organ prolapse at the time of the questioning on vaginal prosthesis: the TAPP trial

Study protocol

A study protocol for HEalth-Related quality of life-intervention in survivors of Breast and other cancers experiencing cancer-related fatigue using TraditionAL Chinese Medicine: the HERBAL trial

Study protocol

High-frequency spinal cord stimulation at 10 kHz for the treatment of painful diabetic neuropathy: design of a multicenter, randomized controlled trial (SENZA-PDN)

Study protocol

Brief educational video plus telecare to enhance recovery for older emergency department patients with acute musculoskeletal pain: study protocol for the BETTER randomized controlled trial

Study protocol

Impacts of chest compression cycle length and real-time feedback with a CPRmeter® on chest compression quality in out-of-hospital cardiac arrest: study protocol for a multicenter randomized controlled factorial plan trial

Research

Can learning about trials be child’s play? A qualitative exploration of the ‘Schools Teaching Awareness of Randomised Trials’ (START) initiative