Authors
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Murray, Elizabeth -More
Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2014
INTERVENTION: Potential participants will be patients referred or self‐referred to participating community alcohol services. They will attend the CAS for their first assessment appointment with an alcohol counsellor as usual, where the counselor will record baseline measures including previous week's alcohol consumption and current levels of anxiety. If at the end of the assessment appointment the counsellor decides the patient meets the inclusion criteria to enter the trial, they will tell them about the trial and give them a participant information sheet. Interested eligible patients will then be consented by the alcohol counsellor at the end of their assessment appointment, and also asked for consent for the trial manager to contact them by phone or text after a 24‐hour 'cooling off' period to see if they still want to participate in the trial (see patient information sheet and consent form). If they do still want to participate in the trial they will be randomised by computer to HELP‐Drink or face‐to‐face treatment at the CAS, and given a date for the facilitated introduction to the website at a convenient location, or for treatment as usual at the CAS. 1. Participants randomised to HELP‐Drink will access one online module a week for six weeks, supported by tailored text messages and/or phone calls. 2. Participants randomised to face‐to‐face treatment will attend weekly for the standard number of appointments (usually six). At 90 days after completing their treatment programmes, all participants will be contacted by email to complete online outcome measure questionnaires (including a measure of satisfaction with the intervention and whether they dropped out of the treatment to which they were randomised). 25/05/2018: Amendment made The RCT was split into two sequential studies due to poor initial recruitment necessitating a change in recruitment strategy. Study 1 Recruitment was from community drug and alcohol services. Study 1 started 01/10/14 and ran till 01/08/15 CONDITION: Hazardous or harmful alcohol use ; Mental and Behavioural Disorders PRIMARY OUTCOME: Current primary outcome measures as of 20/06/2018:; 1. Recruitment as a percentage of eligible patients; 2. Retention, measured by completeness of online data collection at 3 months as a percentage of patients randomised; ; Previous primary outcome measures:; The outcomes examined at three months and 12 months will be: ; 1. Recruitment; 2. Study attrition; 3. Change in unit consumption of alcohol per week (using TOT‐AL, an online beverage‐specific measure which requires participants to enter the type and quantity of alcohol drinks consumed on each day of the past week) SECONDARY OUTCOME: Current secondary outcome measures as of 20/06/2018:; 1. Average alcohol intake in units measured using TOT‐AL, an online beverage‐specific measure, at baseline, 1 and 3 months; 2. Problem drinking assessed using AUDIT at baseline and 3 months; 3. Psychological distress assessed using CORE‐10 at baseline and 3 months; 4. Confidence in avoiding alcohol assessed using SCQ‐8 at baseline and 3 months; 5. Satisfaction with care assessed using CSQ‐8 at 3 months; 6. Adherence to the intervention (for those randomised to this arm), measured through automated recording of numbers of log‐ins and numbers of pages visited at each log‐in, at 3 months; 7. Other sources of support accessed during treatment, measured using a drop down menu of options: group therapy; horticulture; acupuncture; art therapy; other therapies (participant to state in free text); at 1 and 3 months; ; Previous secondary outcome measures:; 1. Demographic and clinical characteristics will be recorded at baseline, which will enable us to determine if there are inequalities in access to the online alcohol programme; Secondary outcomes examined at three months and 12 months will be: ; 2. Change in participant satisfaction with care (measured using the 8‐item Client Satisfaction Questionnaire (CSQ‐8); 3. Change in Hospital Anxiety and Depression scale; 4. Change in well‐being scores (using EQ‐5D); 5. Health professional time (a proforma will be used to record health professional time in minutes taken in both interventions, including failed encounters) INCLUSION CRITERIA: 1. Participants will be hazardous and harmful drinkers in north London, identified using a validated screening tool such as AUDIT, referred from primary care, secondary care, or self‐referred, to CAS. 2. Patients aged 18 or over at time of screening 3. Diagnosis of an alcohol use disorder using AUDIT criteria (score 8 or over) 4. Residing in a stable place of residence 5. Providing informed consent for randomisation, treatment and follow‐up 6. Patients without prior internet experience, or without home access to the internet will be included, but will be offered additional training as part of their facilitated access to DYD. All participants will be given information about local free or low‐cost public internet access points, such as libraries, health centres and cluster rooms.
Epistemonikos ID: 310ab07ab9baa25d119bbe55427f75921902a5b8
First added on: Aug 22, 2024