DIAMOND (DIgital Alcohol Management ON Demand): a mixed methods feasibility RCT and embedded process evaluation of a digital health intervention to reduce hazardous and harmful alcohol use

BACKGROUND: Alcohol is a major risk factor for preventable illness, with huge cost to healthcare economies. There is a role for alcohol-specific digital health interventions (DHI), but there have been few randomised controlled trials (RCT) comparing DHI with face-to-face treatment. Such trials are complex and face obstacles in recruitment and retention. METHODS: Mixed-methods feasibility RCT of an alcohol DHI, testing recruitment, online data-collection and randomisation processes, with an embedded process evaluation. Recruitment ran from October 2014 for 9 months. Participants were adults drinking at hazardous and harmful levels, attending four community drug and alcohol services (CDAS) in London. Participants completed baseline demographic, alcohol-related and other psychological questionnaires online and were randomised to HeLP-Alcohol, a six-module DHI with weekly reminder prompts (phone, email or text message), which mirrors face-to-face treatment, or to face-to-face treatment at CDAS. Alcohol counsellors took part in qualitative interviews at the end of the study. RESULTS: Alcohol counsellors screened 1253 patients. One thousand one hundred eighty-nine did not meet inclusion criteria so were excluded: 579 were dependent drinkers, 548 had health conditions that made them ineligible to take part and 62 were ineligible for other reasons including homelessness. Of the 64 patients who were eligible to take part, 54 declined to participate, with 36 stating a preference for face-to-face treatment, 13 gave no reason, and 5 gave other reasons including not wanting to use a computer. Ten consented but then 3 changed their minds, so we were able to randomise 7 participants to the study (11% of eligible). Five alcohol counsellors agreed to be interviewed for the process evaluation and provided the following feedback: Although most of their colleagues were enthusiastic about the trial, some were not at equipoise in recruiting; potential participants also declared strong preference to intervention arm from the outset. These factors affected recruitment. Counsellors also lacked time to undertake the data inputting and follow-up of participants in addition to their everyday work. CONCLUSIONS: This feasibility study aimed to test recruitment, randomisation, retention and data collection methods but recruited only 7 participants so these aims were not fully achieved. This illustrates to all researchers of complex interventions the importance of conducting feasibility studies and is generalisable to areas other than alcohol research. CDAS were seeing larger numbers of non-dependent drinkers with complex additional problems than alcohol commissioners expected. CDAS clients and some counsellors were not at equipoise for recruitment. Alternative settings for recruitment need to be explored in future trials. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number: ISRCTN31789096, DOI 10.1186/ISRCTN31789096