Skip to main content
SpringerLink
Log in

Multifaceted intervention to promote the regular visiting of patients with diabetes to primary care physicians: rationale, design and conduct of a cluster-randomized controlled trial. The Japan Diabetes Outcome Intervention Trial-2 study protocol

  • Original article
  • Published:
Diabetology International Aims and scope Submit manuscript

Abstract

Background

Regular clinic visits are essential for keeping diabetes well controlled. Nevertheless, about half of the known diabetic patients do not receive regular medical care, as estimated by the National Survey in Japan. From the viewpoint of medical resources, primary care physicians (PCPs) should provide regular medical care to the many diabetic patients in Japan. Therefore, maintaining regular care and improving care quality are expected for diabetes treatment at the PCP level.

Methods/design

The Japan Diabetes Outcome Intervention Trial-2 (J-DOIT2) is a cluster-randomized two-armed intervention study. Fifteen district medical associations (DMAs) and 300 PCPs will participate. The PCPs in each DMA will be divided into two groups and randomized, with each group acting as a cluster within the DMA. Then, 3,750 type 2 diabetes patients (aged 40–64 years) will be recruited. In the intervention group, patients will receive reminders for medical visits to their PCP and lifestyle advice over the telephone or face to face. The PCPs will be provided with benchmark indicators of his/her own diabetes treatment activities. In the control group, the PCPs will provide ordinary medical treatment to his/her patients. With a 1-year intervention and follow-up period, the primary outcome will be the rate of patient dropout from regular medical care of both groups. The quality of diabetes treatment provided by the PCPs will also be evaluated.

Discussion

The J-DOIT2 is a large-scale trial for improvement of diabetes care in an ordinary primary care setting and is expected to contribute to establishing widely adoptable countermeasures for diabetes.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

Abbreviations

CG:

Control group

CRC:

Clinical research coordinator

DMA:

District medical association

IG:

Intervention group

J-DOIT:

Japan Diabetes Outcome Intervention Trial

J-DOIT2-LT:

J-DOIT2 large-scale trial

J-DOIT2-PS:

J-DOIT2 pilot study

LA:

Lifestyle adviser

NVD:

Next visit day

PCP:

Primary care physician

TSC:

Treatment support center

References

  1. King H, Aubert RE, Herman WH. Global burden of diabetes, 1995–2025: prevalence, numerical estimates, and projections. Diabetes Care. 1998;21(9):1414–31.

    Article  PubMed  CAS  Google Scholar 

  2. Yazaki Y, Kadowaki T. Combating diabetes and obesity in Japan. Nat Med. 2006;12(1):73–4.

    Article  PubMed  CAS  Google Scholar 

  3. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 1998;352:837–53.

    Article  Google Scholar 

  4. Gæde P, Vedel P, Larsen N, Jensen GV, Parving HH, Pedersen O. Multifactorial intervention and cardiovascular disease in patients with type 2 diabetes. N Engl J Med. 2003;348(5):383–93.

    Article  PubMed  Google Scholar 

  5. Outline for the Results of the National Health and Nutrition Survey Japan, 2007. http://www.nih.go.jp/eiken/english/research/pdf/nhns2007.pdf. Accessed 1 Sept 2010.

  6. Smith DM, Weinberger M, Katz BP. A controlled trial to increase office visits and reduce hospitalizations of diabetic patients. J Gen Intern Med. 1987;2(4):232–8.

    Article  PubMed  CAS  Google Scholar 

  7. Campbell M, Grimshaw J, Steen N. Sample size calculations for cluster randomised trials. Changing Professional Practice in Europe Group (EU BIOMED II Concerted Action). J Health Serv Res Policy. 2000;5(1):12–6.

    PubMed  CAS  Google Scholar 

  8. Campbell MK, Mollison J, Grimshaw JM. Cluster trials in implementation research: estimation of intracluster correlation coefficients and sample size. Stat Med. 2001;20(3):391–9.

    Article  PubMed  CAS  Google Scholar 

  9. Hayes RJ, Bennett S. Simple sample size calculation for cluster-randomized trials. Int J Epidemiol. 1999;28(2):319–26.

    Article  PubMed  CAS  Google Scholar 

  10. White H. A heteroskedasticity-consistent covariance matrix estimator and a direct test for heteroskedasticity. Econometrica. 1980;48(4):817–38.

    Article  Google Scholar 

Download references

Acknowledgments

This study is funded by a Health and Labour Sciences Research Grant (Strategic Outcomes Research Program for Research on Diabetes and Comprehensive Research on Diabetes/Cardiovascular and Life-Style Related Diseases) from the Ministry of Health, Labour and Welfare of Japan. The funding body has determined the goal of this study, that is, verification of the intervention for reducing patient dropout from regular diabetes treatment.

Conflict of interest

The authors declare that they have no conflict of interest.

Author information

Authors and Affiliations

  1. Office of Strategic Outcomes Research Program, Japan Foundation for the Promotion of International Medical Research Cooperation, 1-21-13 Toyama, Shinjuku-ku, Tokyo, 162-0052, Japan

    Kazuo Izumi & Mitsuhiko Noda

  2. Department of Epidemiology and Healthcare Research, Kyoto University Graduate School of Medicine, Yoshidakonoe-cho, Sakyo-ku, Kyoto, Kyoto, 606-8501, Japan

    Yasuaki Hayashino

  3. First Department of Internal Medicine, Faculty of Medicine, Toyama University, 2630 Sugitani, Toyama, Toyama, 930-0194, Japan

    Katsuya Yamazaki & Hikari Suzuki

  4. Division of Medical Informatics, Department of Clinical Research and Informatics, Research Institute, National Center for Global Health and Medicine, 1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan

    Naoki Ishizuka

  5. Section of Medicine, Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama, 2630 Sugitani, Toyama, Toyama, 930-0194, Japan

    Masashi Kobayashi

  6. Department of Diabetes and Metabolic Medicine, National Center for Global Health and Medicine, 1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan

    Mitsuhiko Noda

Authors
  1. Kazuo Izumi
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Yasuaki Hayashino
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Katsuya Yamazaki
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Hikari Suzuki
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Naoki Ishizuka
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Masashi Kobayashi
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Mitsuhiko Noda
    View author publications

    You can also search for this author in PubMed Google Scholar

Consortia

The J-DOIT2 Study Group

Corresponding author

Correspondence to Mitsuhiko Noda.

Additional information

About this article

Cite this article

Izumi, K., Hayashino, Y., Yamazaki, K. et al. Multifaceted intervention to promote the regular visiting of patients with diabetes to primary care physicians: rationale, design and conduct of a cluster-randomized controlled trial. The Japan Diabetes Outcome Intervention Trial-2 study protocol. Diabetol Int 1, 83–89 (2010). https://doi.org/10.1007/s13340-010-0015-6

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s13340-010-0015-6

Keywords

Search

Navigation