title: Integrating technology into complex intervention trial processes: a case study.
abstract: Trials of complex interventions are associated with high costs and burdens in terms of paperwork, management, data collection, validation, and intervention fidelity assessment occurring across multiple sites. Traditional data collection methods rely on paper-based forms, where processing can be time-consuming and error rates high. Electronic source data collection can potentially address many of these inefficiencies, but has not routinely been used in complex intervention trials. Here we present the use of an on-line system for managing all aspects of data handling and for the monitoring of trial processes in a multicentre trial of a complex intervention. We custom built a web-accessible software application for the delivery of ENGAGE-HD, a multicentre trial of a complex physical therapy intervention. The software incorporated functionality for participant randomisation, data collection and assessment of intervention fidelity. It was accessible to multiple users with differing levels of access depending on required usage or to maintain blinding. Each site was supplied with a 4G-enabled iPad for accessing the system. The impact of this system was quantified through review of data quality and collation of feedback from site coordinators and assessors through structured process interviews.
  
  
  
  The custom-built system was an efficient tool for collecting data and managing trial processes. Although the set-up time required was significant, using the system resulted in an overall data completion rate of 98.5% with a data query rate of 0.1%, the majority of which were resolved in under a week. Feedback from research staff indicated that the system was highly acceptable for use in a research environment. This was a reflection of the portability and accessibility of the system when using the iPad and its usefulness in aiding accurate data collection, intervention fidelity and general administration.
  
  
  
  A combination of commercially available hardware and a bespoke online database designed to support data collection, intervention fidelity and trial progress provides a viable option for streamlining trial processes in a multicentre complex intervention trial. There is scope to further extend the system to cater for larger trials and add further functionality such as automatic reporting facilities and participant management support.
  
  
  
  ISRCTN65378754 , registered on 13 March 2014.
authors.affiliation: South East Wales Trials Unit, Centre For Trials Research, College of Biomedical and Life Sciences, Cardiff University, 7th Floor Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK.
authors.forename: Cheney J G
authors.initials: CJ
authors.lastname: Drew
authors.affiliation: South East Wales Trials Unit, Centre For Trials Research, College of Biomedical and Life Sciences, Cardiff University, 7th Floor Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK.
authors.forename: Vincent
authors.initials: V
authors.lastname: Poile
authors.affiliation: South East Wales Trials Unit, Centre For Trials Research, College of Biomedical and Life Sciences, Cardiff University, 7th Floor Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK.
authors.forename: Rob
authors.initials: R
authors.lastname: Trubey
authors.affiliation: South East Wales Trials Unit, Centre For Trials Research, College of Biomedical and Life Sciences, Cardiff University, 7th Floor Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK.
authors.forename: Gareth
authors.initials: G
authors.lastname: Watson
authors.affiliation: South East Wales Trials Unit, Centre For Trials Research, College of Biomedical and Life Sciences, Cardiff University, 7th Floor Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK.
authors.forename: Mark
authors.initials: M
authors.lastname: Kelson
authors.affiliation: South East Wales Trials Unit, Centre For Trials Research, College of Biomedical and Life Sciences, Cardiff University, 7th Floor Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK.
authors.forename: Julia
authors.initials: J
authors.lastname: Townson
authors.affiliation: School of Biosciences, Cardiff University, Biosciences 3, Park Place, Cardiff, CF10 3BB, UK.
authors.forename: Anne
authors.initials: A
authors.lastname: Rosser
authors.affiliation: South East Wales Trials Unit, Centre For Trials Research, College of Biomedical and Life Sciences, Cardiff University, 7th Floor Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK.
authors.forename: Kerenza
authors.initials: K
authors.lastname: Hood
authors.affiliation: Department of Biobehavioral Sciences, Teachers College, Columbia University, New York, NY, USA.|School of Health Care Sciences, Cardiff University, 35-43 Eastgate House, Newport Road, Cardiff, CF24 0AB, UK.
authors.forename: Lori
authors.initials: L
authors.lastname: Quinn
authors.affiliation: South East Wales Trials Unit, Centre For Trials Research, College of Biomedical and Life Sciences, Cardiff University, 7th Floor Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK. busseme@cardiff.ac.uk.|School of Health Care Sciences, Cardiff University, 35-43 Eastgate House, Newport Road, Cardiff, CF24 0AB, UK. busseme@cardiff.ac.uk.
authors.forename: Monica
authors.identifier: 0000-0002-5331-5909
authors.initials: M
authors.lastname: Busse
mesh_terms: D003625:Data Collection; D006801:Humans; D015337:Multicenter Studies as Topic / Q000379:methods*; D012107:Research Design
keywords: Complex intervention trials; Data collection; Database design; Fidelity; Process evaluation; Technology