Study protocol for the road to hierarchical diabetes management at primary care (ROADMAP) study in China: a cluster randomised controlled trial.

Item request has been placed! ×
Item request cannot be made. ×
loading   Processing Request
Read More Add to Saved list
  • Additional Information
    • Corporate Authors:
      ROADMAP study group
    • Source:
      Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE
    • Publication Information:
      Original Publication: [London] : BMJ Publishing Group Ltd, 2011-
    • Subject Terms:
      Disease Management* ; Life Style* ; Quality of Life*; Diabetes Mellitus, Type 2/*therapy ; Primary Health Care/*methods ; Telemedicine/*methods; Adult ; China ; Female ; Humans ; Male ; Middle Aged
    • Abstract:
      Introduction: Diabetes management in primary care remains suboptimal in China, despite its inclusion in the essential public health service (EPHS). We aimed to evaluate the effectiveness of a mobile health (mHealth) based and three-tiered diabetes management system in diverse Chinese contexts.
      Methods and Analysis: This is a cluster randomised controlled trial, named road to hierarchical diabetes management at primary care (ROADMAP). 19 008 patients with type 2 diabetes (T2D) were recruited from primary care clinics in 864 communities across 144 counties/districts of 24 provinces. Eligible participants were adult patients diagnosed with T2D and registered for diabetes management in communities. Patients within the same communities (clusters) were randomly allocated into the intervention or control arm for 1 year in a 2:1 ratio. The control arm patients received usual care as EPHS packaged: at least four blood glucose (BG) and blood pressure (BP) tests, and lifestyle and medication instruction, yearly, from primary care providers. The intervention arm patients received at least two BG and one BP tests, monthly, and lifestyle and treatment instruction from a three-tiered contracted team. A mHealth platform, Graded ROADMAP, enabled test results uploading and sharing, and patient referral within the team. The intervention participants will be further divided into basic or intensive intervention group according to whether they were actively using the Your Doctor App. The primary outcome is the BG control rate with glycated haemoglobin (HbA1c)<7.0%. Secondary outcomes include control rates and changes of ABC (HbA1c, BP and low-density lipoprotein cholesterol) and fasting BG, hypoglycaemia episodes and health-related quality of life (EuroQol (EQ-5D)).
      Ethics and Dissemination: The trial has been approved by the Institutional Review Board at Shanghai Sixth People's Hospital. Findings on the intervention effectiveness will be disseminated through peer-reviewed journals, conference presentations and other relevant mechanisms.
      Trial Registration Number: ChiCTR-IOC-17011325.
      Competing Interests: Competing interests: None declared.
      (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
    • References:
      Diabetes Res Clin Pract. 2016 Jun;116:218-29. (PMID: 27321339)
      Pharmacoeconomics. 2015 Aug;33(8):811-31. (PMID: 25787932)
      Arch Intern Med. 2011 Sep 26;171(17):1542-50. (PMID: 21949161)
      Int J Equity Health. 2017 Jul 1;16(1):80. (PMID: 28666449)
      Mayo Clin Proc. 2010 Dec;85(12 Suppl):S3-4. (PMID: 21106869)
      J Diabetes Investig. 2014 Sep;5(5):563-9. (PMID: 25411625)
      BMJ. 2019 Jun 21;365:l2358. (PMID: 31227480)
      BMC Fam Pract. 2018 Jan 9;19(1):11. (PMID: 29316889)
      JAMA. 2013 Sep 4;310(9):948-59. (PMID: 24002281)
      Lancet Diabetes Endocrinol. 2014 Aug;2(8):634-47. (PMID: 24842598)
      Int J Environ Res Public Health. 2018 Dec 25;16(1):. (PMID: 30585243)
      BMC Public Health. 2019 Jun 24;19(1):816. (PMID: 31234818)
      Int J Equity Health. 2017 Mar 3;16(1):42. (PMID: 28253876)
      Aust J Prim Health. 2015;21(4):391-408. (PMID: 26329878)
      Int J Qual Health Care. 2011 Dec;23(6):664-73. (PMID: 21937586)
      Patient Educ Couns. 2011 Dec;85(3):336-47. (PMID: 21316898)
      Am J Med. 2013 Oct;126(10):925.e11-22. (PMID: 23810406)
      J Clin Lab Anal. 2018 Jan;32(1):null. (PMID: 28220976)
      Zhonghua Nei Ke Za Zhi. 2018 Dec 1;57(12):885-893. (PMID: 30486556)
      Lancet. 2017 Dec 9;390(10112):2584-2594. (PMID: 29231837)
      PLoS One. 2016 Apr 20;11(4):e0153791. (PMID: 27096738)
      BMJ Glob Health. 2018 Sep 19;3(5):e000854. (PMID: 30258653)
      J Gen Intern Med. 2009 Mar;24(3):349-55. (PMID: 19137379)
      BMJ. 2019 Jun 19;365:l2349. (PMID: 31217222)
      Diabetes Technol Ther. 2015 Oct;17(10):735-44. (PMID: 26171728)
    • Contributed Indexing:
      Keywords: cluster trial; management; mobile health; primary care; type 2 diabetes
    • Publication Date:
      Date Created: 20200109 Date Completed: 20210210 Latest Revision: 20210210
    • Publication Date:
      20240628
    • Accession Number:
      PMC6955560
    • Accession Number:
      10.1136/bmjopen-2019-032734
    • Accession Number:
      31911516