title: 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.
abstract: OBJECTIVE
  To assess the effect of second generation, home based telehealth on health related quality of life, anxiety, and depressive symptoms over 12 months in patients with long term conditions.
  
  
  METHODS
  A study of patient reported outcomes (the Whole Systems Demonstrator telehealth questionnaire study; baseline n=1573) was nested in a pragmatic, cluster randomised trial of telehealth (the Whole Systems Demonstrator telehealth trial, n=3230). General practice was the unit of randomisation, and telehealth was compared with usual care. Data were collected at baseline, four months (short term), and 12 months (long term). Primary intention to treat analyses tested treatment effectiveness; multilevel models controlled for clustering by general practice and a range of covariates. Analyses were conducted for 759 participants who completed questionnaire measures at all three time points (complete case cohort) and 1201 who completed the baseline assessment plus at least one other assessment (available case cohort). Secondary per protocol analyses tested treatment efficacy and included 633 and 1108 participants in the complete case and available case cohorts, respectively.
  
  
  METHODS
  Provision of primary and secondary care via general practices, specialist nurses, and hospital clinics in three diverse regions of England (Cornwall, Kent, and Newham), with established integrated health and social care systems.
  
  
  METHODS
  Patients with chronic obstructive pulmonary disease (COPD), diabetes, or heart failure recruited between May 2008 and December 2009.
  
  
  METHODS
  Generic, health related quality of life (assessed by physical and mental health component scores of the SF-12, and the EQ-5D), anxiety (assessed by the six item Brief State-Trait Anxiety Inventory), and depressive symptoms (assessed by the 10 item Centre for Epidemiological Studies Depression Scale).
  
  
  RESULTS
  In the intention to treat analyses, differences between treatment groups were small and non-significant for all outcomes in the complete case (0.480 ≤ P ≤ 0.904) or available case (0.181 ≤ P ≤ 0.905) cohorts. The magnitude of differences between trial arms did not reach the trial defined, minimal clinically important difference (0.3 standardised mean difference) for any outcome in either cohort at four or 12 months. Per protocol analyses replicated the primary analyses; the main effect of trial arm (telehealth v usual care) was non-significant for any outcome (complete case cohort 0.273 ≤ P ≤ 0.761; available case cohort 0.145 ≤ P ≤ 0.696).
  
  
  CONCLUSIONS
  Second generation, home based telehealth as implemented in the Whole Systems Demonstrator Evaluation was not effective or efficacious compared with usual care only. Telehealth did not improve quality of life or psychological outcomes for patients with chronic obstructive pulmonary disease, diabetes, or heart failure over 12 months. The findings suggest that concerns about potentially deleterious effect of telehealth are unfounded for most patients.
  
  
  BACKGROUND
  ISRCTN43002091.
authors: School of Health Sciences, City University London, London EC1A 7QN, UK.
authors: Martin
authors: M
authors: Cartwright
authors: Shashivadan P
authors: SP
authors: Hirani
authors: Lorna
authors: L
authors: Rixon
authors: Michelle
authors: M
authors: Beynon
authors: Helen
authors: H
authors: Doll
authors: Peter
authors: P
authors: Bower
authors: Martin
authors: M
authors: Bardsley
authors: Adam
authors: A
authors: Steventon
authors: Martin
authors: M
authors: Knapp
authors: Catherine
authors: C
authors: Henderson
authors: Anne
authors: A
authors: Rogers
authors: Caroline
authors: C
authors: Sanders
authors: Ray
authors: R
authors: Fitzpatrick
authors: James
authors: J
authors: Barlow
authors: Stanton P
authors: SP
authors: Newman
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001007:Anxiety / Q000453:epidemiology; D016022:Case-Control Studies; D016000:Cluster Analysis; D003863:Depression / Q000453:epidemiology; D003920:Diabetes Mellitus / Q000523:psychology* / Q000628:therapy; D004739:England / Q000453:epidemiology; D005260:Female; D058006:General Practice; D006304:Health Status; D006333:Heart Failure / Q000523:psychology* / Q000628:therapy; D006699:Home Care Services / Q000458:organization & administration / Q000592:standards; D006801:Humans; D008297:Male; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000523:psychology* / Q000628:therapy; D011788:Quality of Life; D011795:Surveys and Questionnaires; D017216:Telemedicine / Q000458:organization & administration / Q000592:standards