title: Challenges in Patient Recruitment, Implementation, and Fidelity in a Mobile Telehealth Study.
abstract: Mobile telehealth (MTH) evaluations in diabetes have been conducted, but few report details and issues related to recruitment, implementation (intervention delivery), fidelity, and context. These have important implications on the interpretation of the findings and effectiveness of the intervention. This article reports these data from an MTH study and describes the challenges experienced in running an intervention such as this in an active clinical environment.
  
  
  
  We conducted a mixed-methods MTH study that included a 9-month randomized controlled trial in people with poorly controlled diabetes. Detailed recruitment data were recorded during the study. Data on contacts between MTH participants and the MTH team were collected and used to report on intervention delivery and fidelity. Meeting and field notes, as well as communications between research team members during the study, were used to report on the contextual factors that affected recruitment, implementation, and fidelity.
  
  
  
  The recruited sample size represented 6% of the total clinic population (n = 1,360) and 10.7% of the number of potentially eligible people at the clinic (n = 802) identified at the beginning of the study. Contextual factors related to patients, healthcare providers, the institution, or the recruitment protocol contributed to influence access to study participants and the number of participants randomized (n = 81). Technical and device-related aspects of the MTH intervention were delivered successfully, but the expected education and clinical feedback by the MTH nurse were not delivered according to the protocol. Although 92.5% of introductory calls were made by the MTH nurses, only 13.3% of expected educational calls were performed. Changes to the MTH nursing staff affected intervention participants differently and contributed to the low fidelity of intervention delivery.
  
  
  
  The current article presents data on the influence of contextual factors on the conduct of this MTH study and underlines the need for these processes to be assessed and reported adequately in future MTH research.
authors.affiliation: 1 Institute of Cardiovascular Science, University College London , London, United Kingdom .
authors.forename: Justine
authors.initials: J
authors.lastname: Baron
authors.affiliation: 1 Institute of Cardiovascular Science, University College London , London, United Kingdom .|2 Centre for Health Services Research, School of Health Sciences, City University London , London, United Kingdom .
authors.forename: Shashivadan
authors.initials: S
authors.lastname: Hirani
authors.affiliation: 1 Institute of Cardiovascular Science, University College London , London, United Kingdom .|2 Centre for Health Services Research, School of Health Sciences, City University London , London, United Kingdom .
authors.forename: Stanton
authors.initials: S
authors.lastname: Newman
mesh_terms: D015190:Blood Glucose Self-Monitoring; D001794:Blood Pressure; D003142:Communication; D003920:Diabetes Mellitus / Q000628:therapy*; D004032:Diet; D015444:Exercise; D006302:Health Services Research / Q000458:organization & administration*; D006801:Humans; D063731:Mobile Applications; D009740:Nursing Staff / Q000458:organization & administration; D010353:Patient Education as Topic; D018579:Patient Selection; D012108:Research Personnel / Q000458:organization & administration; D017216:Telemedicine / Q000458:organization & administration*
keywords: behavioral health; e-health; home health monitoring; mobile health; telehealth