Chris Salisbury|Alicia O’Cathain|Louisa Edwards|Clare Thomas|Daisy Gaunt|Sandra Hollinghurst|Jon Nicholl|Shirley Large|Lucy Yardley|Glyn Lewis|Alexis Foster|Katy Garner|Kimberley Horspool|Mei?See Man|Anne Rogers|Catherine Pope|Padraig Dixon|Alan Montgomery
Effectiveness of an integrated telehealth service for patients with depression: a pragmatic randomised controlled trial of a complex intervention
University of Bristol|University of Sheffield|University of Bristol|University of Bristol|University of Bristol|University of Bristol|University of Sheffield|University of Southampton|University College London|University of Sheffield|University of Bristol|University of Sheffield|University of Bristol|University of Southampton|University of Southampton|University of Bristol|University of Bristol|University of Nottingham
h3backgroundh3 many countries exploring potential telehealth interventions manage rising number people chronic disorders however evidence effectiveness telehealth ambiguous based evidencebased conceptual framework developed integrated telehealth service healthlines service chronic disorders assessed effectiveness patients depression aimed compare healthlines depression service plus usual care usual care alone h3methodsh3 study pragmatic multicentre randomised controlled trial participants recruited 43 general practices three areas england eligible participants needed access internet email patient health questionnaire 9 phq9 score least 10 confirmed diagnosis depression participants individually assigned 11 either healthlines depression service plus usual care usual care alone random assignment done use webbased automated randomisation system stratified site minimised practice phq9 score participants aware allocation outcomes analysed masked healthlines service consisted regular telephone calls nonclinical trained health advisers followed standardised scripts generated interactive software initial assessment goalsetting telephone call advisers called participant six occasions 4 months made three calls intervals roughly 2 months provide reinforcement detect relapse advisers supported participants use online resources including computerised cognitive behavioural therapy sought encourage healthier lifestyles optimise medication improve treatment adherence primary outcome proportion participants responding intervention defined phq9 10 reduction phq9 5 points 4 months randomisation primary analysis based intentiontotreat principle without imputation serious adverse events investigated trial registered current controlled trials number isrctn 14172341 h3findingsh3 july 24 2012 july 31 2013 recruited 609 participants randomly assigning 307 healthlines service plus usual care 302 usual care primary outcome data available 525 86 participants 4 months 68 27 255 individuals intervention group treatment response compared 50 19 270 individuals usual care group adjusted odds ratio 17 95 ci 1125 p0019 compared usual care alone intervention participants reported improvements anxiety better access support advice greater satisfaction support received improvements selfmanagement health literacy trial 70 adverse events reported participants one related intervention increased anxiety discussing depression serious h3interpretationh3 telehealth service based nonclinically trained health advisers supporting patients use internet resources acceptable effective compared usual care results provide support development assessment similar interventions chronic disorders expand care provision h3fundingh3 national institute health research nihr