title: Smartphone- and internet-assisted self-management and adherence tools to manage Parkinson's disease (SMART-PD): study protocol for a randomised controlled trial (v7; 15 August 2014).
abstract: BACKGROUND
  Nonadherence to treatment leads to suboptimal treatment outcomes and enormous costs to the economy. This is especially important in Parkinson's disease (PD). The progressive nature of the degenerative process, the complex treatment regimens and the high rates of comorbid conditions make treatment adherence in PD a challenge. Clinicians have limited face-to-face consultation time with PD patients, making it difficult to comprehensively address non-adherence. The rapid growth of digital technologies provides an opportunity to improve adherence and the quality of decision-making during consultation. The aim of this randomised controlled trial (RCT) is to evaluate the impact of using a smartphone and web applications to promote patient self-management as a tool to increase treatment adherence and working with the data collected to enhance the quality of clinical consultation.
  
  
  METHODS
  A 4-month multicentre RCT with 222 patients will be conducted to compare use of a smartphone- and internet-enabled Parkinson's tracker smartphone app with treatment as usual for patients with PD and/or their carers. The study investigators will compare the two groups immediately after intervention. Seven centres across England (6) and Scotland (1) will be involved. The primary objective of this trial is to assess whether patients with PD who use the app show improved medication adherence compared to those receiving treatment as usual alone. The secondary objectives are to investigate whether patients who receive the app and those who receive treatment as usual differ in terms of quality of life, quality of clinical consultation, overall disease state and activities of daily living. We also aim to investigate the experience of those receiving the intervention by conducting qualitative interviews with a sample of participants and clinicians, which will be administered by independent researchers.
  
  
  BACKGROUND
  ISRCTN45824264 (registered 5 November 2013).
authors.affiliation: uMotif Ltd, London, UK. rashmi@umotif.com.
authors.forename: Rashmi
authors.initials: R
authors.lastname: Lakshminarayana
authors.forename: Duolao
authors.initials: D
authors.lastname: Wang
authors.forename: David
authors.initials: D
authors.lastname: Burn
authors.forename: K Ray
authors.initials: KR
authors.lastname: Chaudhuri
authors.forename: Gemma
authors.initials: G
authors.lastname: Cummins
authors.forename: Clare
authors.initials: C
authors.lastname: Galtrey
authors.forename: Bruce
authors.initials: B
authors.lastname: Hellman
authors.forename: Suvankar
authors.initials: S
authors.lastname: Pal
authors.forename: Jon
authors.initials: J
authors.lastname: Stamford
authors.forename: Malcolm
authors.initials: M
authors.lastname: Steiger
authors.forename: Adrian
authors.initials: A
authors.lastname: Williams
mesh_terms: D000203:Activities of Daily Living; D000978:Antiparkinson Agents / Q000627:therapeutic use*; D040421:Cell Phone; D002985:Clinical Protocols; D004739:England; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D055118:Medication Adherence; D063731:Mobile Applications; D010300:Parkinson Disease / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D011788:Quality of Life; D012017:Referral and Consultation; D012107:Research Design; D012606:Scotland; D012648:Self Care / Q000295:instrumentation / Q000379:methods; D016037:Single-Blind Method; D013813:Therapy, Computer-Assisted / Q000295:instrumentation / Q000379:methods; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000978:Antiparkinson Agents