title: A randomized wait-list control trial to evaluate the impact of a mobile application to improve self-management of individuals with type 2 diabetes: a study protocol.
abstract: Management of diabetes through improved glycemic control and risk factor modification can help prevent long-term complications. Much diabetes management is self-management, in which healthcare providers play a supporting role. Well-designed e-Health solutions targeting behavior change can improve a range of measures, including glycemic control, perceived health, and a reduction in hospitalizations.
  
  
  
  The primary objective of this study is to evaluate if a mobile application designed to improve self-management among patients with type 2 diabetes (T2DM) improves glycemic control compared to usual care. The secondary objectives are to determine the effects on patient experience and health system costs; evaluate how and why the intervention worked as observed; and gain insight into considerations for system-wide scale-up. This pragmatic, randomized, wait-list-control trial will recruit adult participants from three Diabetes Education Programs in Ontario, Canada. The primary outcome is glycemic control (measured by HbA1c). Secondary outcomes include patient-reported outcomes and patient-reported experience measures, health system utilization, and intervention usability. The primary outcome will be analyzed using an ANCOVA, with continuous secondary outcomes analyzed using Poisson regression. Direct observations will be conducted of the implementation and application-specific training sessions provided to each site. Semi-structured interviews will be conducted with participants, healthcare providers, organizational leaders, and system stakeholders as part of the embedded process evaluation. Thematic analysis will be applied to the qualitative data in order to describe the relationships between (a) key contextual factors, (b) the mechanisms by which they effect the implementation of the intervention, and (c) the impact on the outcomes of the intervention, according to the principles of Realist Evaluation.
  
  
  
  The use of mobile health and virtual tools is on the rise in health care, but the evidence of their effectiveness is mixed and their evaluation is often lacking key contextual data. Results from this study will provide much needed information about the clinical and cost-effectiveness of a mobile application to improve diabetes self-management. The process evaluation will provide valuable insight into the contextual factors that influence the application effectiveness, which will inform the potential for adoption and scale.
  
  
  
  Clinicaltrials.gov NCT02813343 . Registered on 24 June 2016 (retrospectively registered). Trial Sponsor: Ontario Telemedicine Network.
authors.affiliation: Women's College Hospital Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, 76 Grenville Ave, Toronto, ON, M5S 1B2, Canada.|Women's College Research Institute, Women's College Hospital, 76 Grenville Ave, Toronto, ON, Canada.
authors.forename: Laura
authors.initials: L
authors.lastname: Desveaux
authors.affiliation: Women's College Hospital Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, 76 Grenville Ave, Toronto, ON, M5S 1B2, Canada.
authors.forename: Payal
authors.initials: P
authors.lastname: Agarwal
authors.affiliation: Women's College Hospital Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, 76 Grenville Ave, Toronto, ON, M5S 1B2, Canada.|Women's College Research Institute, Women's College Hospital, 76 Grenville Ave, Toronto, ON, Canada.|Insititue for Health Policy, Management, and Evaluation, University of Toronto, 155 College St, Toronto, ON, Canada.
authors.forename: Jay
authors.initials: J
authors.lastname: Shaw
authors.affiliation: Women's College Hospital Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, 76 Grenville Ave, Toronto, ON, M5S 1B2, Canada.|Department of Psychiatry, Women's College Hospital and University of Toronto, Toronto, ON, Canada.
authors.forename: Jennifer M
authors.initials: JM
authors.lastname: Hensel
authors.affiliation: Women's College Hospital Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, 76 Grenville Ave, Toronto, ON, M5S 1B2, Canada.|Insititue for Health Policy, Management, and Evaluation, University of Toronto, 155 College St, Toronto, ON, Canada.|Department of Medicine, University of Toronto, Toronto, ON, Canada.
authors.forename: Geetha
authors.initials: G
authors.lastname: Mukerji
authors.affiliation: Women's College Hospital Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, 76 Grenville Ave, Toronto, ON, M5S 1B2, Canada.
authors.forename: Nike
authors.initials: N
authors.lastname: Onabajo
authors.affiliation: Women's College Hospital Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, 76 Grenville Ave, Toronto, ON, M5S 1B2, Canada.
authors.forename: Husayn
authors.initials: H
authors.lastname: Marani
authors.affiliation: Women's College Hospital Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, 76 Grenville Ave, Toronto, ON, M5S 1B2, Canada.|Division of General Internal Medicine, St. Michael's Hospital, 209 Victoria St, Toronto, ON, Canada.|Department of Medicine, University of Toronto, Toronto, ON, Canada.
authors.forename: Trevor
authors.initials: T
authors.lastname: Jamieson
authors.affiliation: Women's College Hospital Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, 76 Grenville Ave, Toronto, ON, M5S 1B2, Canada.|Women's College Research Institute, Women's College Hospital, 76 Grenville Ave, Toronto, ON, Canada.|Department of Family and Community Medicine, Women's College Hospital and University of Toronto, 76 Grenville Ave, Toronto, ON, Canada.
authors.forename: Onil
authors.initials: O
authors.lastname: Bhattacharyya
authors.affiliation: Women's College Hospital Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, 76 Grenville Ave, Toronto, ON, M5S 1B2, Canada.|Department of Family and Community Medicine, Women's College Hospital and University of Toronto, 76 Grenville Ave, Toronto, ON, Canada.
authors.forename: Danielle
authors.initials: D
authors.lastname: Martin
authors.affiliation: Li Ka Shing Centre for Healthcare Analytics Research and Training, St. Michael's Hospital, 209 Victoria St, Toronto, ON, Canada.
authors.forename: Muhammad
authors.initials: M
authors.lastname: Mamdani
authors.affiliation: Li Ka Shing Knowledge Institute, St. Michael's Hospital, 30 Bond St, Toronto, ON, Canada.
authors.forename: Lianne
authors.initials: L
authors.lastname: Jeffs
authors.affiliation: Institute for Clinical Evaluative Sciences, 2075 Bayview Ave, Toronto, ON, Canada.|Insititue for Health Policy, Management, and Evaluation, University of Toronto, 155 College St, Toronto, ON, Canada.|Toronto Rehabilitation Institute, 550 University Avenue, Toronto, ON, Canada.
authors.forename: Walter P
authors.initials: WP
authors.lastname: Wodchis
authors.affiliation: Women's College Hospital Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, 76 Grenville Ave, Toronto, ON, M5S 1B2, Canada.|Women's College Research Institute, Women's College Hospital, 76 Grenville Ave, Toronto, ON, Canada.|Institute for Clinical Evaluative Sciences, 2075 Bayview Ave, Toronto, ON, Canada.|Insititue for Health Policy, Management, and Evaluation, University of Toronto, 155 College St, Toronto, ON, Canada.|Department of Family and Community Medicine, Women's College Hospital and University of Toronto, 76 Grenville Ave, Toronto, ON, Canada.
authors.forename: Noah M
authors.initials: NM
authors.lastname: Ivers
authors.affiliation: Women's College Hospital Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, 76 Grenville Ave, Toronto, ON, M5S 1B2, Canada. sacha.bhatia@wchospital.ca.|Women's College Research Institute, Women's College Hospital, 76 Grenville Ave, Toronto, ON, Canada. sacha.bhatia@wchospital.ca.|Department of Medicine, University of Toronto, Toronto, ON, Canada. sacha.bhatia@wchospital.ca.
authors.forename: R Sacha
authors.initials: RS
authors.lastname: Bhatia
mesh_terms: D003924:Diabetes Mellitus, Type 2 / Q000628:therapy*; D006801:Humans; D063731:Mobile Applications / Q000592:standards*; D017063:Outcome Assessment, Health Care; D012648:Self Care / Q000592:standards*; D017216:Telemedicine / Q000592:standards*; D014850:Waiting Lists
keywords: Diabetes; E-Health; Implementation science; Mobile health; Randomized controlled trial; Self-management