title: Preventative tele-health supported services for early stage chronic obstructive pulmonary disease: a protocol for a pragmatic randomized controlled trial pilot.
abstract: BACKGROUND
  Chronic Obstructive Pulmonary Disease (COPD) is a prevalent debilitating long term condition. It is the second most common cause of emergency admission to hospital in the UK and remains one of the most costly conditions to treat through acute care.Tele-health monitoring offers potential to reduce the rates of re-hospitalisation and emergency department visits and improve quality of life for people with COPD. However, the current evidence base to support technology adoption and implementation is limited and the resource implications for implementing tele-health in practice can be very high. This trial will employ tele-health monitoring in a preventative capacity for patients diagnosed with early stage COPD following discharge from hospital to determine whether it reduces their need for additional health service support or hospital admission and improves their quality of life.
  
  
  METHODS
  We describe a pilot study for a two arm, one site randomized controlled trial (RCT) to determine the effect of tele-health monitoring on self-management, quality of life and patient satisfaction. Sixty patients who have been discharged from one acute trust with a primary diagnosis of COPD and who have agreed to receive community clinical support following discharge from acute care will be randomly assigned to one of two groups: (a) Tele-health supported Community COPD Service; or (b) Usual Care. The tele-health supported service involves the patient receiving two home visits with a specialist COPD clinician (nurse or physiotherapist) then participating in daily tele-monitoring over an eight week period. Usual care consists of six home visits to the patient by specialist COPD clinicians again over eight successive weeks. Health status and quality of life data for all participants will be measured at baseline, on discharge from the service and at six months post discharge from the service.
  
  
  CONCLUSIONS
  The tele-health service under study is a complex service delivered through a collaboration between local authority and health care partners. The implementation of this service demanded significant changes to established working patterns and has been a challenging process requiring considerable planning - a challenge that many providers are likely to face in the future.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN68856013.
authors.affiliation: University of Sheffield, South Yorkshire, UK. d.a.fitzsimmons@sheffield.ac.uk
authors.forename: Deborah A
authors.initials: DA
authors.lastname: Fitzsimmons
authors.forename: Jill
authors.initials: J
authors.lastname: Thompson
authors.forename: Mark
authors.initials: M
authors.lastname: Hawley
authors.forename: Gail A
authors.initials: GA
authors.lastname: Mountain
mesh_terms: D003153:Community Health Services; D018450:Disease Progression; D004636:Emergency Service, Hospital; D006304:Health Status; D006792:House Calls; D006801:Humans; D010351:Patient Discharge; D010359:Patient Readmission; D017060:Patient Satisfaction; D010865:Pilot Projects; D011314:Preventive Health Services / Q000379:methods*; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis / Q000628:therapy*; D011788:Quality of Life; D012107:Research Design; D012648:Self Care; D017216:Telemedicine; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom