Dataset Information

DIAMOND (DIgital Alcohol Management ON Demand): a feasibility RCT and embedded process evaluation of a digital health intervention to reduce hazardous and harmful alcohol use recruiting in hospital emergency departments and online.

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.

SUBMITTER: Hamilton FL

PROVIDER: S-EPMC6003139 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

DIAMOND (DIgital Alcohol Management ON Demand): a feasibility RCT and embedded process evaluation of a digital health intervention to reduce hazardous and harmful alcohol use recruiting in hospital emergency departments and online.

Hamilton Fiona L FL Hornby Jo J Sheringham Jessica J Linke Stuart S Ashton Charlotte C Moore Kevin K Stevenson Fiona F Murray Elizabeth E

Pilot and feasibility studies 20180615

<h4>Background</h4>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.<h4>Methods</h4>We conducted a feasibility RCT of an alcohol DHI, testing recruitment, online data-collec ...[more]

PMID: 29946479

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Project description:BackgroundAlcohol misuse is common in the United Kingdom Armed Forces (UKAF), with prevalence significantly higher than in the general population. To date, digital health initiatives to support alcohol misuse have focused on male individuals, who represent approximately 89% of the UKAF. However, female veterans drink disproportionally more than female members of the public.ObjectiveThis 2-arm participant-blinded (single-blinded) confirmatory randomized controlled trial (RCT) aims to assess the efficacy of a brief alcohol intervention (DrinksRation) in reducing weekly self-reported alcohol consumption between baseline and a 3-month follow-up (day 84) among women who have served in the UKAF.MethodsIn this 2-arm single-blinded RCT, a smartphone app that includes interactive user-focused features tailored toward the needs of female veterans and designed to enhance participants' motivations to reduce the amount of alcohol they consume is compared with the UK Chief Medical Officer guidance on alcohol consumption. The trial will be conducted among women who have served at least 1 day of paid service in the UKAF. Recruitment, consent, and data collection will be carried out automatically through the DrinksRation app or the BeAlcoholSmart platform. The primary outcome is change in self-reported weekly alcohol consumption between baseline (day 0) and the 3-month follow-up (day 84) measured using the Timeline Follow Back for alcohol consumption. The secondary outcome is the change in the Alcohol Use Disorders Identification Test score measured at baseline and 3-month follow-up between the control and intervention groups. The process evaluation measures include (1) app use and (2) usability ratings as measured by the mHealth App Usability Questionnaire.ResultsRCT recruitment will begin in January 2024 and last for 5 months. We aim to complete all data collection, including interviews, by May 2024.ConclusionsThis study will assess whether a smartphone app tailored to the needs of women who have served in the UKAF is efficacious in reducing self-reported alcohol consumption. If successful, the digital therapeutics platform could be used not only to support women who have served in the UKAF but also for other conditions and disorders.Trial registrationClinicalTrials.gov NCT05970484; https://www.clinicaltrials.gov/study/NCT05970484.International registered report identifier (irrid)PRR1-10.2196/51531.

Project description:BackgroundAlcohol Brief Intervention (ABI) uses a motivational counselling approach to support individuals to reduce excessive alcohol consumption. There is growing evidence on ABI's use within various health care settings, although how they work and which components enhance success is largely unknown. This paper reports on the qualitative part of a mixed methods study. It explores enablers and barriers associated with alcohol reduction following an ABI. It focuses on alcohol's place within participants' lives and their personal perspectives on reducing consumption. There are a number of randomised controlled trials in this field though few ABI studies have addressed the experiences of hazardous/harmful drinkers. This study examines factors associated with alcohol reduction in harmful/hazardous drinkers following ABI.MethodsThis qualitative study was underpinned by a realist evaluation approach and involved semi-structured interviews with ten harmful or hazardous alcohol drinkers. Participants (n = 10) were from the intervention arm of a randomised controlled trial (n = 124). All had received ABI, a 20 min motivational counselling interview, six months previously, and had reduced their alcohol consumption. Interviews were recorded, transcribed verbatim and thematically analysed.ResultsParticipants described their views on alcohol, its' place in their lives, their personal perspectives on reducing their consumption and future aspirations.ConclusionsThe findings provide an insight into participants' views on alcohol, ABI, and the barriers and enablers to change. Participants described a cost benefit analysis, with some conscious consideration of the advantages and disadvantages of reducing intake or abstaining from alcohol. Findings suggest that, whilst hospital admission can act as a catalyst, encouraging individuals to reflect on their alcohol consumption through ABI may consolidate this, turning this reflective moment into action. Sustainability may be enhanced by the presence of a 'significant other' who encourages and experiences benefit. In addition having a purpose or structure with activities linked to employment and/or social and leisure pursuits offers the potential to enhance and sustain reduced alcohol consumption.Trial registrationTrial registration number TRN NCT00982306 September 22nd 2009.

Project description:ObjectiveThis study piloted procedures and obtained data on intervention acceptability to determine the feasibility of a definitive randomised controlled trial (RCT) of the effectiveness of a computer-based brief intervention in the emergency department (ED).DesignTwo-arm, multi-site, pilot RCT.Setting and participantsAdolescents aged 12-17 years presenting to three Canadian pediatric EDs from July 2010 to January 2013 for an alcohol-related complaint.InterventionsStandard medical care plus computer-based screening and personalised assessment feedback (experimental group) or standard care plus computer-based sham (control group). ED and research staff, and adolescents were blinded to allocation.OutcomesMain: change in alcohol consumption from baseline to 1- and 3 months post-intervention. Secondary: recruitment and retention rates, intervention acceptability and feasibility, perception of group allocation among ED and research staff, and change in health and social services utilisation.ResultsOf the 340 adolescents screened, 117 adolescents were eligible and 44 participated in the study (37.6% recruitment rate). Adolescents allocated to the intervention found it easy, quick and informative, but were divided on the credibility of the feedback provided (agreed it was credible: 44.4%, disagreed: 16.7%, unsure: 16.7%, no response: 22.2%). We found no evidence of a statistically significant relationship between which interventions adolescents were allocated to and which interventions staff thought they received. Alcohol consumption, and health and social services data were largely incomplete due to modest study retention rates of 47.7% and 40.9% at 1- and 3 months post-intervention, respectively.ConclusionsA computer-based intervention was acceptable to adolescents and delivery was feasible in the ED in terms of time to use and ease of use. However, adjustments are needed to the intervention to improve its credibility. A definitive RCT will be feasible if protocol adjustments are made to improve recruitment and retention rates; and increase the number of study sites and research staff.Trial registrationclinicaltrials.gov NCT01146665.

Project description:BackgroundIn low- and middle-income countries (LMIC), the mismatch between the number of individuals needing and those receiving treatment for alcohol use disorders (AUD) is substantial. In order to provide suggestions for the scaling up of effective service provision we systematically reviewed the current evidence on the effectiveness of AUD-focused psychosocial interventions in LMIC.MethodsWe used a systematic review methodology following the PRISMA guidelines. Twelve electronic databases listing published and grey literature were searched and only randomized-controlled trials (RCTs) were included. Where possible, effect sizes were calculated using Hedges' g indices.ResultsTwenty-one RCTs conducted in 15 different LMIC between 1992 and 2018 fulfilled inclusion criteria. Most studies employed brief one-on-one interventions facilitated by trained primary care staff. Eighty-six percent of RCTs based their interventions on the principles of motivational interviewing (MI) with the majority supplementing MI-based interventions with alcohol-tailored elements of cognitive-behavioral therapy (CBT). The remaining RCTs employed CBT-components exclusively. Just over 40% of studies included in quantitative analyses (n=17) yielded an at least medium-sized effect (g≥.50) of the respective intervention compared to alcohol-related and unrelated control conditions or waiting list. Only half of the trials implementing the widely applied MI-based approaches (or MI-based approaches blended with CBT-elements) were superior to their respective control conditions.ConclusionTo date, a relatively small number of RCTs investigating AUD-focused treatments has been conducted in LMIC. The majority of between condition effect size estimates were small and no type of intervention can clearly be recommended over another. No RCTs were conducted in conflict-affected areas in LMIC although they would merit particular attention since AUD is often linked to trauma-related mental health disorders. More RCTs in LMIC are required and alternatives to MI-based approaches should be investigated. This systematic review summarizes properties of effective interventions and provides implications for future research.

Project description:AimTo compare the effectiveness of practitioner versus digitally delivered interventions for reducing hazardous and harmful alcohol consumption.DesignSystematic review and network meta-analysis comprising comprehensive search for randomised controlled trials, robust screening and selection methods and appraisal with the Cochrane Risk of Bias tool. Network meta-analyses were conducted in Stata using random effects, frequentist models. The confidence in network meta-analysis (CINeMA) tool was used to assess confidence in effect sizes.SettingOnline or community or health settings where the intervention was immediately accessible without referral.ParticipantsNon treatment-seeking hazardous or harmful drinkers.MeasurementsPrimary outcome was mean difference in alcohol consumption (g/wk); secondary outcome was number of single high intensity drinking episodes. Baseline consumption was analysed as a covariate.FindingsOf 201 included trials (94 753 participants), 152 reported a consumption outcome that could be converted to grams/week; 104 reported number of single high intensity drinking episodes. At 1 and 6 months, practitioner delivered interventions reduced consumption more than digitally delivered interventions (1 month: -23 g/wk (95% CI, -43 to -2); 6 months: -14 g/wk [95% CI, -25 to -3]). At 12 months there was no evidence of difference between practitioner and digitally delivered interventions (-6 g/wk [95% CI, -24 to 12]). There was no evidence of a difference in single high intensity drinking episodes between practitioner and digitally delivered interventions at any time point. Effect sizes were small, but could impact across a population with relatively high prevalence of hazardous and harmful drinking. Heterogeneity was a concern. Some inconsistency was indicated at 1 and 6 months, but little evidence was apparent at 12 months.ConclusionPractitioner delivered interventions for reducing hazardous and harmful alcohol consumption are more effective than digitally delivered interventions up to 6 months; at 12 months there is no evidence of a difference.

Dataset Information

DIAMOND (DIgital Alcohol Management ON Demand): a feasibility RCT and embedded process evaluation of a digital health intervention to reduce hazardous and harmful alcohol use recruiting in hospital emergency departments and online.

Background

Methods

Results

Conclusions

Trial registration

Publications

DIAMOND (DIgital Alcohol Management ON Demand): a feasibility RCT and embedded process evaluation of a digital health intervention to reduce hazardous and harmful alcohol use recruiting in hospital emergency departments and online.

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