title: Who does not participate in telehealth trials and why? A cross-sectional survey.
abstract: BACKGROUND
  Telehealth interventions use information and communication technology to provide clinical support. Some randomised controlled trials of telehealth report high patient decline rates. A large study was undertaken to determine which patients decline to participate in telehealth trials and their reasons for doing so.
  
  
  METHODS
  Two linked randomised controlled trials were undertaken, one for patients with depression and one for patients with raised cardiovascular disease risk (the Healthlines Study). The trials compared usual care with additional support delivered by the telephone and internet. Patients were recruited via their general practice and could return a form about why they were not participating.
  
  
  RESULTS
  Of the patients invited, 82.9% (20,021/24,152) did not accept the study invite, either by returning a decline form (n = 7134) or by not responding (n = 12,887). In both trials patients registered at deprived general practices were less likely to accept the study invite. Decline forms were received from 29.5% (7134/24,152) of patients invited. There were four frequently reported types of reasons for declining. The most common was telehealth-related: 54.7% (3889/,7115) of decliners said they did not have access or the skills to use the internet and/or computers. This was more prevalent amongst older patients and patients registered at deprived general practices. The second was health need-related: 40.1% (n = 2852) of decliners reported that they did not need additional support for their health condition. The third was related to life circumstances: 27.2% (n = 1932) of decliners reported being too busy. The fourth was research-related: 15.3% (n = 1092) of decliners were not interested in the research.
  
  
  CONCLUSIONS
  A large proportion of patients declining participation in these telehealth trials did so because they were unable to engage with telehealth or did not perceive a need for it. This has implications for engagement with telehealth in routine practice, as well as for trials, with a need to offer technological support to increase patients' engagement with telehealth. More generally, triallists should assess why people decline to participate in their studies.
  
  
  BACKGROUND
  The Healthlines Study has the following trial registrations: depression trial: ISRCTN14172341 (registered 26 June 2012) and CVD risk trial: ISRCTN27508731 (registered 05 July 2012).
authors.affiliation: School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK. alexis.foster@sheffield.ac.uk.
authors.forename: Alexis
authors.initials: A
authors.lastname: Foster
authors.affiliation: School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK. k.horspool@sheffield.ac.uk.
authors.forename: Kimberley A
authors.initials: KA
authors.lastname: Horspool
authors.affiliation: Centre for Academic Primary Care, NIHR School for Primary Care Research, School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. louisa.edwards@bristol.ac.uk.
authors.forename: Louisa
authors.initials: L
authors.lastname: Edwards
authors.affiliation: Centre for Academic Primary Care, NIHR School for Primary Care Research, School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. clare.thomas@bristol.ac.uk.
authors.forename: Clare L
authors.initials: CL
authors.lastname: Thomas
authors.affiliation: Centre for Academic Primary Care, NIHR School for Primary Care Research, School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. c.salisbury@bristol.ac.uk.
authors.forename: Chris
authors.initials: C
authors.lastname: Salisbury
authors.affiliation: Nottingham Clinical Trials Unit, University of Nottingham, C Floor, South Block, Queen's Medical Centre, Nottingham, NG7 2UH, UK. alan.montgomery@nottingham.ac.uk.
authors.forename: Alan A
authors.initials: AA
authors.lastname: Montgomery
authors.affiliation: School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK. a.ocathain@sheffield.ac.uk.
authors.forename: Alicia
authors.initials: A
authors.lastname: O'Cathain
mesh_terms: D000328:Adult; D000368:Aged; D001292:Attitude to Computers; D005260:Female; D058006:General Practice; D007722:Health Knowledge, Attitudes, Practice; D006297:Health Services Accessibility; D006801:Humans; D008297:Male; D008875:Middle Aged; D010342:Patient Acceptance of Health Care; D018579:Patient Selection; D010465:Perception; D011203:Poverty; D035842:Research Subjects / Q000523:psychology*; D011795:Surveys and Questionnaires; D017216:Telemedicine; D013997:Time Factors