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      Evaluating the effectiveness of the smartphone app, Drink Less, compared with the NHS alcohol advice webpage, for the reduction of alcohol consumption among hazardous and harmful adult drinkers in the UK at 6‐month follow‐up: protocol for a randomised controlled trial

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          ABSTRACT

          Background and Aims

          Digital interventions are effective for reducing alcohol consumption but evidence is limited regarding smartphone apps. Drink Less is a theory‐ and evidence‐informed app to help people reduce their alcohol consumption that has been refined in terms of its content and design for usability across the sociodemographic spectrum. We aim to evaluate the effectiveness and cost‐effectiveness of recommending Drink Less at reducing alcohol consumption compared with usual digital care.

          Design

          Two‐arm individually randomised controlled trial.

          Setting

          Online trial in the United Kingdom (UK).

          Participants

          Hazardous or harmful drinkers (Alcohol Use Disorders Identification Test [AUDIT] score ≥8) aged 18+ who want to drink less alcohol ( n = 5562). Participants will be recruited from July 2020 to May 2022 using multiple strategies with a focus on remote digital methods.

          Intervention and comparator

          Participants will be randomised to receive either an email recommending that they use Drink Less (intervention) or view the National Health Service (NHS) webpage on alcohol advice (comparator).

          Measurements

          The primary outcome is change in self‐reported weekly alcohol consumption, assessed using the extended AUDIT‐Consumption, between baseline and 6‐month follow‐up. Secondary outcomes include change in self‐reported weekly alcohol consumption assessed at 1‐ and 3‐month follow‐ups, and the proportion of hazardous drinkers; alcohol‐related problems and injury; health‐related quality of life; and use of health services assessed at 6‐month follow‐up. Effectiveness will be examined with adjusted regression models, adjusting for baseline alcohol consumption and using an intention‐to‐treat approach. A mixed‐methods process evaluation will assess engagement, acceptability and mechanism of action. Economic evaluations will be conducted using both a short‐ and longer‐term time horizon.

          Comments

          This study will establish the effectiveness and cost‐effectiveness of the Drink Less app at reducing alcohol consumption among hazardous and harmful adult drinkers and will be the first randomised controlled trial of an alcohol reduction app for the general population in the United Kingdom. This study will inform the decision on whether it is worth investing resources in large‐scale implementation.

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          Most cited references71

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          G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences

          G*Power (Erdfelder, Faul, & Buchner, 1996) was designed as a general stand-alone power analysis program for statistical tests commonly used in social and behavioral research. G*Power 3 is a major extension of, and improvement over, the previous versions. It runs on widely used computer platforms (i.e., Windows XP, Windows Vista, and Mac OS X 10.4) and covers many different statistical tests of the t, F, and chi2 test families. In addition, it includes power analyses for z tests and some exact tests. G*Power 3 provides improved effect size calculators and graphic options, supports both distribution-based and design-based input modes, and offers all types of power analyses in which users might be interested. Like its predecessors, G*Power 3 is free.
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            Developing and evaluating complex interventions: the new Medical Research Council guidance

            Evaluating complex interventions is complicated. The Medical Research Council's evaluation framework (2000) brought welcome clarity to the task. Now the council has updated its guidance
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              Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework

              Background It is increasingly acknowledged that ‘acceptability’ should be considered when designing, evaluating and implementing healthcare interventions. However, the published literature offers little guidance on how to define or assess acceptability. The purpose of this study was to develop a multi-construct theoretical framework of acceptability of healthcare interventions that can be applied to assess prospective (i.e. anticipated) and retrospective (i.e. experienced) acceptability from the perspective of intervention delivers and recipients. Methods Two methods were used to select the component constructs of acceptability. 1) An overview of reviews was conducted to identify systematic reviews that claim to define, theorise or measure acceptability of healthcare interventions. 2) Principles of inductive and deductive reasoning were applied to theorise the concept of acceptability and develop a theoretical framework. Steps included (1) defining acceptability; (2) describing its properties and scope and (3) identifying component constructs and empirical indicators. Results From the 43 reviews included in the overview, none explicitly theorised or defined acceptability. Measures used to assess acceptability focused on behaviour (e.g. dropout rates) (23 reviews), affect (i.e. feelings) (5 reviews), cognition (i.e. perceptions) (7 reviews) or a combination of these (8 reviews). From the methods described above we propose a definition: Acceptability is a multi-faceted construct that reflects the extent to which people delivering or receiving a healthcare intervention consider it to be appropriate, based on anticipated or experienced cognitive and emotional responses to the intervention. The theoretical framework of acceptability (TFA) consists of seven component constructs: affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs, and self-efficacy. Conclusion Despite frequent claims that healthcare interventions have assessed acceptability, it is evident that acceptability research could be more robust. The proposed definition of acceptability and the TFA can inform assessment tools and evaluations of the acceptability of new or existing interventions. Electronic supplementary material The online version of this article (doi:10.1186/s12913-017-2031-8) contains supplementary material, which is available to authorized users.
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                Author and article information

                Contributors
                c.garnett@ucl.ac.uk
                Journal
                Addiction
                Addiction
                10.1111/(ISSN)1360-0443
                ADD
                Addiction (Abingdon, England)
                John Wiley and Sons Inc. (Hoboken )
                0965-2140
                1360-0443
                26 November 2020
                February 2021
                : 116
                : 2 ( doiID: 10.1111/add.v116.2 )
                : 412-425
                Affiliations
                [ 1 ] Department of Behavioural Science and Health University College London London
                [ 2 ] School of Health and Related Research University of Sheffield Sheffield
                [ 3 ] Public Health England London
                [ 4 ] Department of Psychology University of Sheffield Sheffield
                [ 5 ] Department of Primary Care and Public Health Imperial College London London
                [ 6 ] Bristol Population Health Science Institute University of Bristol Bristol
                [ 7 ] Population Health Sciences Institute Newcastle University Newcastle upon Tyne
                [ 8 ] Department of Clinical, Educational and Health Psychology University College London London
                [ 9 ] School of Psychological Science University of Bristol Bristol
                [ 10 ] Department of Applied Health Research University College London London
                Author notes
                [*] [* ] Correspondence to: Claire Garnett, University College London, Gower Street, London, WC1E 6BT.

                E‐mail: c.garnett@ 123456ucl.ac.uk

                Author information
                https://orcid.org/0000-0002-6589-299X
                https://orcid.org/0000-0003-0529-4135
                https://orcid.org/0000-0001-8586-1261
                https://orcid.org/0000-0003-1684-5238
                https://orcid.org/0000-0002-7790-5559
                https://orcid.org/0000-0001-9864-459X
                https://orcid.org/0000-0002-4049-993X
                https://orcid.org/0000-0002-2797-5428
                Article
                ADD15287 ADD-20-0616.R1
                10.1111/add.15287
                8436762
                33067856
                3bb69bad-2a3e-45b8-a7be-585a445e76d1
                © 2020 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction

                This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

                History
                : 30 July 2020
                : 27 May 2020
                : 05 October 2020
                Page count
                Figures: 2, Tables: 1, Pages: 14, Words: 7658
                Funding
                Funded by: Cancer Research UK , doi 10.13039/501100000289;
                Award ID: C1417/A22962
                Funded by: NIHR School for Public Health Research , doi 10.13039/501100012349;
                Funded by: Public Health Research Programme , doi 10.13039/501100001921;
                Award ID: NIHR127651
                Funded by: Society for the Study of Addiction , doi 10.13039/100014660;
                Funded by: UK Centre for Tobacco and Alcohol Studies
                Categories
                Trial Protocol
                Trial Protocol
                Custom metadata
                2.0
                February 2021
                Converter:WILEY_ML3GV2_TO_JATSPMC version:6.0.7 mode:remove_FC converted:13.09.2021

                Clinical Psychology & Psychiatry
                alcohol reduction,behaviour change,digital,intervention,protocol,rct,smartphone app,uk

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