Fiona L Hamilton1, Jo Hornby1, Jessica Sheringham2, Stuart Linke3, Charlotte Ashton4, Kevin Moore5, Fiona Stevenson1, Elizabeth Murray1. 1. 1eHealth Unit, Department of Primary Care & Population Health, University College London, Upper 3rd Floor, Royal Free Campus, Rowland Hill Street, London, NW3 2PF UK. 2. 2Department of Applied Health Research, UCL, London, UK. 3. 3Camden and Islington NHS Foundation Trust, London, UK. 4. Camden and Islington Public Health, London, UK. 5. 5Institute for Liver and Digestive Health, UCL, London, UK.
Abstract
BACKGROUND: The harmful use of alcohol is a causal factor in more than 200 disease and injury conditions and leads to over 3 million deaths every year worldwide. Relatively few problem alcohol users access treatment due to stigma and lack of services. Alcohol-specific digital health interventions (DHI) may help them, but trial data comparing DHI with face-to-face treatment are lacking. METHODS: We conducted a feasibility RCT of an alcohol DHI, testing recruitment, online data-collection and randomisation processes, with an embedded process evaluation. Recruitment ran from October 2015 for 12 months. Participants were adults, drinking at hazardous and harmful levels, recruited from hospital emergency departments (ED) in London or recruited online. Participants were randomised to HeLP-Alcohol, a six module DHI with weekly reminder prompts (phone, email or text message), or to face-to-face treatment as usual (TAU). Participants were invited to take part in qualitative interviews after the trial. RESULTS: The trial website was accessed 1074 times: 420 people completed online eligibility questionnaires; 350 did not meet eligibility criteria, 51 declined to participate, and 19 were recruited and randomised. Follow-up data were collected from three participants (retention 3/19), and four agreed to be interviewed for the process evaluation. The main themes of the interviews were:Participants were not at equipoise. They wanted to try the website and were disappointed to be randomised to face-to-face, so they were less engaged and dropped out.Other reasons for drop out included not accepting that they had a drink problem; problem drinking interfering with their ability to take part in a trial or forgetting appointments; having a busy life and being randomised to TAU made it difficult to attend appointments. CONCLUSIONS: This feasibility RCT aimed to test recruitment, randomisation, retention, and data collection methods, but recruited only 19 participants. This illustrates the importance of undertaking feasibility studies prior to fully powered RCTs. From the qualitative interviews we found that potential recruits were not at equipoise for recruitment. An alternative methodology, for example a preference RCT recruiting from multiple locations, needs to be explored in future trials. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number: ISRCTN31789096.
BACKGROUND: The harmful use of alcohol is a causal factor in more than 200 disease and injury conditions and leads to over 3 million deaths every year worldwide. Relatively few problem alcohol users access treatment due to stigma and lack of services. Alcohol-specific digital health interventions (DHI) may help them, but trial data comparing DHI with face-to-face treatment are lacking. METHODS: We conducted a feasibility RCT of an alcohol DHI, testing recruitment, online data-collection and randomisation processes, with an embedded process evaluation. Recruitment ran from October 2015 for 12 months. Participants were adults, drinking at hazardous and harmful levels, recruited from hospital emergency departments (ED) in London or recruited online. Participants were randomised to HeLP-Alcohol, a six module DHI with weekly reminder prompts (phone, email or text message), or to face-to-face treatment as usual (TAU). Participants were invited to take part in qualitative interviews after the trial. RESULTS: The trial website was accessed 1074 times: 420 people completed online eligibility questionnaires; 350 did not meet eligibility criteria, 51 declined to participate, and 19 were recruited and randomised. Follow-up data were collected from three participants (retention 3/19), and four agreed to be interviewed for the process evaluation. The main themes of the interviews were:Participants were not at equipoise. They wanted to try the website and were disappointed to be randomised to face-to-face, so they were less engaged and dropped out.Other reasons for drop out included not accepting that they had a drink problem; problem drinking interfering with their ability to take part in a trial or forgetting appointments; having a busy life and being randomised to TAU made it difficult to attend appointments. CONCLUSIONS: This feasibility RCT aimed to test recruitment, randomisation, retention, and data collection methods, but recruited only 19 participants. This illustrates the importance of undertaking feasibility studies prior to fully powered RCTs. From the qualitative interviews we found that potential recruits were not at equipoise for recruitment. An alternative methodology, for example a preference RCT recruiting from multiple locations, needs to be explored in future trials. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number: ISRCTN31789096.
Authors: Alison M McDonald; Rosemary C Knight; Marion K Campbell; Vikki A Entwistle; Adrian M Grant; Jonathan A Cook; Diana R Elbourne; David Francis; Jo Garcia; Ian Roberts; Claire Snowdon Journal: Trials Date: 2006-04-07 Impact factor: 2.279
Authors: M Dawn Teare; Munyaradzi Dimairo; Neil Shephard; Alex Hayman; Amy Whitehead; Stephen J Walters Journal: Trials Date: 2014-07-03 Impact factor: 2.279