Martin Cartwright|Shashivadan P. Hirani|Lorna Rixon|Michelle Beynon|Helen Doll|Peter Bower|Martin Bardsley|Adam Steventon|Martín Knapp|C. Henderson|Anne Rogers|Caroline Sanders|R Fitzpatrick|James Barlow|Stanton Newman
Effect of telehealth on quality of life and psychological outcomes over 12 months (Whole Systems Demonstrator telehealth questionnaire study): nested study of patient reported outcomes in a pragmatic, cluster randomised controlled trial
City, University of London|City, University of London|City, University of London|City, University of London|University of East Anglia|University of Manchester|Nuffield Trust|Nuffield Trust|London School of Economics and Political Science|London School of Economics and Political Science|University of Southampton|University of Manchester|University of Oxford|Imperial College London|City, University of London
assess effect second generation home based telehealth health related quality life anxiety depressive symptoms 12 months patients long term conditionsa study patient reported outcomes whole systems demonstrator telehealth questionnaire study baseline n1573 nested pragmatic cluster randomised trial telehealth whole systems demonstrator telehealth trial n3230 general practice unit randomisation telehealth compared usual care data collected baseline four months short term 12 months long term primary intention treat analyses tested treatment effectiveness multilevel models controlled clustering general practice range covariates analyses conducted 759 participants completed questionnaire measures three time points complete case cohort 1201 completed baseline assessment plus least one assessment available case cohort secondary per protocol analyses tested treatment efficacy included 633 1108 participants complete case available case cohorts respectivelyprovision primary secondary care via general practices specialist nurses hospital clinics three diverse regions england cornwall kent newham established integrated health social care systemspatients chronic obstructive pulmonary disease copd diabetes heart failure recruited may 2008 december 2009generic health related quality life assessed physical mental health component scores sf12 eq5d anxiety assessed six item brief statetrait anxiety inventory depressive symptoms assessed 10 item centre epidemiological studies depression scalein intention treat analyses differences treatment groups small nonsignificant outcomes complete case 0480 p 0904 available case 0181 p 0905 cohorts magnitude differences trial arms reach trial defined minimal clinically important difference 03 standardised mean difference outcome either cohort four 12 months per protocol analyses replicated primary analyses main effect trial arm telehealth v usual care nonsignificant outcome complete case cohort 0273 p 0761 available case cohort 0145 p 0696second generation home based telehealth implemented whole systems demonstrator evaluation effective efficacious compared usual care telehealth improve quality life psychological outcomes patients chronic obstructive pulmonary disease diabetes heart failure 12 months findings suggest concerns potentially deleterious effect telehealth unfounded patientsisrctn43002091