Cargando…

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: 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 (D...

Descripción completa

Detalles Bibliográficos
Autores principales: Hamilton, Fiona L., Hornby, Jo, Sheringham, Jessica, Linke, Stuart, Ashton, Charlotte, Moore, Kevin, Stevenson, Fiona, Murray, Elizabeth
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6003139/
https://www.ncbi.nlm.nih.gov/pubmed/29946479
http://dx.doi.org/10.1186/s40814-018-0303-7
_version_ 1783332315593703424
author Hamilton, Fiona L.
Hornby, Jo
Sheringham, Jessica
Linke, Stuart
Ashton, Charlotte
Moore, Kevin
Stevenson, Fiona
Murray, Elizabeth
author_facet Hamilton, Fiona L.
Hornby, Jo
Sheringham, Jessica
Linke, Stuart
Ashton, Charlotte
Moore, Kevin
Stevenson, Fiona
Murray, Elizabeth
author_sort Hamilton, Fiona L.
collection PubMed
description 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 ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s40814-018-0303-7) contains supplementary material, which is available to authorized users.
format Online
Article
Text
id pubmed-6003139
institution National Center for Biotechnology Information
language English
publishDate 2018
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-60031392018-06-26 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. Hornby, Jo Sheringham, Jessica Linke, Stuart Ashton, Charlotte Moore, Kevin Stevenson, Fiona Murray, Elizabeth Pilot Feasibility Stud Research 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 ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s40814-018-0303-7) contains supplementary material, which is available to authorized users. BioMed Central 2018-06-15 /pmc/articles/PMC6003139/ /pubmed/29946479 http://dx.doi.org/10.1186/s40814-018-0303-7 Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research
Hamilton, Fiona L.
Hornby, Jo
Sheringham, Jessica
Linke, Stuart
Ashton, Charlotte
Moore, Kevin
Stevenson, Fiona
Murray, Elizabeth
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6003139/
https://www.ncbi.nlm.nih.gov/pubmed/29946479
http://dx.doi.org/10.1186/s40814-018-0303-7
work_keys_str_mv AT hamiltonfional diamonddigitalalcoholmanagementondemandafeasibilityrctandembeddedprocessevaluationofadigitalhealthinterventiontoreducehazardousandharmfulalcoholuserecruitinginhospitalemergencydepartmentsandonline
AT hornbyjo diamonddigitalalcoholmanagementondemandafeasibilityrctandembeddedprocessevaluationofadigitalhealthinterventiontoreducehazardousandharmfulalcoholuserecruitinginhospitalemergencydepartmentsandonline
AT sheringhamjessica diamonddigitalalcoholmanagementondemandafeasibilityrctandembeddedprocessevaluationofadigitalhealthinterventiontoreducehazardousandharmfulalcoholuserecruitinginhospitalemergencydepartmentsandonline
AT linkestuart diamonddigitalalcoholmanagementondemandafeasibilityrctandembeddedprocessevaluationofadigitalhealthinterventiontoreducehazardousandharmfulalcoholuserecruitinginhospitalemergencydepartmentsandonline
AT ashtoncharlotte diamonddigitalalcoholmanagementondemandafeasibilityrctandembeddedprocessevaluationofadigitalhealthinterventiontoreducehazardousandharmfulalcoholuserecruitinginhospitalemergencydepartmentsandonline
AT moorekevin diamonddigitalalcoholmanagementondemandafeasibilityrctandembeddedprocessevaluationofadigitalhealthinterventiontoreducehazardousandharmfulalcoholuserecruitinginhospitalemergencydepartmentsandonline
AT stevensonfiona diamonddigitalalcoholmanagementondemandafeasibilityrctandembeddedprocessevaluationofadigitalhealthinterventiontoreducehazardousandharmfulalcoholuserecruitinginhospitalemergencydepartmentsandonline
AT murrayelizabeth diamonddigitalalcoholmanagementondemandafeasibilityrctandembeddedprocessevaluationofadigitalhealthinterventiontoreducehazardousandharmfulalcoholuserecruitinginhospitalemergencydepartmentsandonline