title: Text message-based diabetes self-management support (SMS4BG): study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Addressing the increasing prevalence, and associated disease burden, of diabetes is a priority of health services internationally. Interventions to support patients to effectively self-manage their condition have the potential to reduce the risk of costly and debilitating complications. The utilisation of mobile phones to deliver self-management support allows for patient-centred care at the frequency and intensity that patients desire from outside the clinic environment. Self-Management Support for Blood Glucose (SMS4BG) is a novel text message-based intervention for supporting people with diabetes to improve self-management behaviours and achieve better glycaemic control and is tailored to individual patient preferences, demographics, clinical characteristics, and culture. This study aims to assess whether SMS4BG can improve glycaemic control in adults with poorly controlled diabetes. This paper outlines the rationale and methods of the trial.
  
  
  METHODS
  A two-arm, parallel, randomised controlled trial will be conducted across New Zealand health districts. One thousand participants will be randomised at a 1:1 ratio to receive SMS4BG, a theoretically based and individually tailored automated text message-based diabetes self-management support programme (intervention) in addition to usual care, or usual care alone (control). The primary outcome is change in glycaemic control (HbA1c) at 9 months. Secondary outcomes include glycaemic control at 3 and 6 months, self-efficacy, self-care behaviours, diabetes distress, health-related quality of life, perceived social support, and illness perceptions. Cost information and healthcare utilisation will also be collected as well as intervention satisfaction and interaction.
  
  
  CONCLUSIONS
  This study will provide information on the effectiveness of a text message-based self-management support tool for people with diabetes. If found to be effective it has the potential to provide individualised support to people with diabetes across New Zealand (and internationally), thus extending care outside the clinic environment.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry: ACTRN12614001232628 .
authors.affiliation: National Institute for Health Innovation, University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand. r.dobson@auckland.ac.nz.
authors.forename: Rosie
authors.identifier: http://orcid.org/0000-0003-0122-1000
authors.initials: R
authors.lastname: Dobson
authors.affiliation: National Institute for Health Innovation, University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand.|Waitemata District Health Board, Auckland, New Zealand.
authors.forename: Robyn
authors.initials: R
authors.lastname: Whittaker
authors.affiliation: National Institute for Health Innovation, University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand.
authors.forename: Yannan
authors.initials: Y
authors.lastname: Jiang
authors.affiliation: School of Counselling, Human Services and Social Work, Faculty of Education, University of Auckland, Auckland, New Zealand.
authors.forename: Matthew
authors.initials: M
authors.lastname: Shepherd
authors.affiliation: National Institute for Health Innovation, University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand.
authors.forename: Ralph
authors.initials: R
authors.lastname: Maddison
authors.affiliation: National Institute for Health Innovation, University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand.
authors.forename: Karen
authors.initials: K
authors.lastname: Carter
authors.affiliation: Waitemata District Health Board, Auckland, New Zealand.
authors.forename: Richard
authors.initials: R
authors.lastname: Cutfield
authors.affiliation: Waitemata District Health Board, Auckland, New Zealand.
authors.forename: Catherine
authors.initials: C
authors.lastname: McNamara
authors.affiliation: Auckland District Health Board, Auckland, New Zealand.
authors.forename: Manish
authors.initials: M
authors.lastname: Khanolkar
authors.affiliation: Auckland District Health Board, Auckland, New Zealand.|School of Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.
authors.forename: Rinki
authors.initials: R
authors.lastname: Murphy
mesh_terms: D015415:Biomarkers / Q000378:metabolism; D001786:Blood Glucose / Q000378:metabolism; D040421:Cell Phone; D002985:Clinical Protocols; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D006442:Glycated Hemoglobin / Q000378:metabolism; D015438:Health Behavior; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D009520:New Zealand; D010353:Patient Education as Topic; D017060:Patient Satisfaction; D011788:Quality of Life; D012107:Research Design; D012307:Risk Factors; D012648:Self Care / Q000295:instrumentation*; D017216:Telemedicine / Q000295:instrumentation*; D060145:Text Messaging; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D001786:Blood Glucose; D006442:Glycated Hemoglobin; C517652:hemoglobin A1c protein, human
keywords: Diabetes mellitus; Mobile phone; SMS; Self-management; Text message; mHealth