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Preventing chronic disease in patients with low health literacy using eHealth and teamwork in primary healthcare: protocol for a cluster randomised controlled trial
  1. Sharon M Parker1,
  2. Nigel Stocks2,
  3. Don Nutbeam3,
  4. Louise Thomas1,
  5. Elizabeth Denney-Wilson4,
  6. Nicholas Zwar5,
  7. Jon Karnon6,
  8. Jane Lloyd1,
  9. Manny Noakes7,
  10. Siaw-Teng Liaw8,
  11. Annie Lau9,
  12. Richard Osborne10,
  13. Mark F Harris1
  1. 1Centre for Primary Health Care and Equity, University of New South Wales, Sydney, New South Wales, Australia
  2. 2Discipline of General Practice, University of Adelaide, Adelaide, South Australia, Australia
  3. 3Sydney School of Public Health, University of Sydney, Sydney, New South Wales, Australia
  4. 4Sydney Nursing School, University of Sydney, Sydney, New South Wales, Australia
  5. 5School of Medicine, University of Wollongong, Wollongong, New South Wales, Australia
  6. 6School of Public Health, University of Adelaide, Adelaide, South Australia, Australia
  7. 7Nutrition and Health Program, CSIRO Health and Biosecurity, Adelaide, South Australia, Australia
  8. 8School of Public Health and Community Medicine, University of New South Wales, Sydney, New South Wales, Australia
  9. 9Centre for Health Informatics, Australian Institute of Health Innovation, Macquarie University, Sydney, New South Wales, Australia
  10. 10School of Health and Social Development, Centre for Population Health Research, Faculty of Health, Deakin University, Melbourne, Victoria, Australia
  1. Correspondence to Professor Mark F Harris; m.f.harris{at}unsw.edu.au

Abstract

Introduction Adults with lower levels of health literacy are less likely to engage in health-promoting behaviours. Our trial evaluates the impacts and outcomes of a mobile health-enhanced preventive intervention in primary care for people who are overweight or obese.

Methods and analysis A two-arm pragmatic practice-level cluster randomised trial will be conducted in 40 practices in low socioeconomic areas in Sydney and Adelaide, Australia. Forty patients aged 40–70 years with a body mass index ≥28 kg/m2 will be enrolled per practice. The HeLP-general practitioner (GP) intervention includes a practice-level quality improvement intervention (medical record audit and feedback, staff training and practice facilitation visits) to support practices to implement the clinical intervention for patients. The clinical intervention involves a health check visit with a practice nurse based on the 5As framework (assess, advise, agree, assist and arrange), the use of a purpose-built patient-facing app, my snapp, and referral for telephone coaching. The primary outcomes are change in health literacy, lifestyle behaviours, weight, waist circumference and blood pressure. The study will also evaluate changes in quality of life and health service use to determine the cost-effectiveness of the intervention and examine the experiences of practices in implementing the programme.

Ethics and dissemination The study has been approved by the University of New South Wales (UNSW) Human Research Ethics Committee (HC17474) and ratified by the University of Adelaide Human Research Ethics committee. There are no restrictions on publication, and findings of the study will be made available to the public via the Centre for Primary Health Care and Equity website and through conference presentations and research publications. Deidentified data and meta-data will be stored in a repository at UNSW and made available subject to ethics committee approval.

Trial Registrationregistration number ACTRN12617001508369; Pre-results.

  • overweight
  • obesity
  • primary care
  • preventive medicine
  • health literacy
  • m-health

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Footnotes

  • Contributors SMP codrafted the paper and protocol documents on which it was based. NS contributed to and was chief investigator (CI) on the peer-reviewed funding proposal and commented on the paper and protocol documents on which it was based specially data collection and intervention in general practice. DN contributed to and was CI on the peer-reviewed funding proposal and contributed to the overall design of the study and intervention and content of the paper and protocol documents on which it was based. LT codrafted the paper and protocol documents on which it was based. ED-W contributed to and was CI on the peer-reviewed funding proposal and contributed to the design of the study and content of the paper and protocol documents on which it was based especially in the education components of the intervention. NZ contributed to and was CI on the peer-reviewed funding proposal and commented on the paper and protocol documents on which it was based especially in relation to the role of general practice. JK contributed to and was CI on the peer-reviewed funding proposal especially the health economic component and commented on the paper and protocol documents on which it was based. JL contributed to and was associate investigator (AI) on the peer-reviewed funding proposal especially the health economic component and commented on the paper and protocol documents on which it was based. MN contributed to and was CI on the peer-reviewed funding proposal especially the nutrition component and commented on the paper. S-TL contributed to and was CI on the peer-reviewed funding proposal especially the informatics component and commented on the paper and protocol documents on which it was based. AL contributed to and was CI on the peer-reviewed funding proposal especially the m-health component and commented on the paper and protocol documents on which it was based. RO contributed to and was AI on the peer-reviewed funding proposal especially the health literacy component and commented on the paper and protocol documents on which it was based. MFH is lead Chief Investigator, developed and led the peer-reviewed funding proposal including the design of the study and intervention and codrafted the paper and protocol documents on which it was based.

  • Funding This work is supported by National Health and Medical Research Council (NHMRC) of Australia project grant number APP1125681 (2017). RO is funded in part through an NHMRC Senior Research Fellowship (APP1059122).

  • Competing interests None declared.

  • Patient consent Obtained.

  • Ethics approval The study has been approved by the University of New South Wales Human Research Ethics Committee (HC17474) and ratified by the University of Adelaide Human Research Ethics committee.

  • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.