A randomized controlled trial to prevent glycemic relapse in longitudinal diabetes care: Study protocol (NCT00362193)

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• 作者：Mary Margaret Huizinga (12) (2) (3)
  Ayumi Shintani (4)
  Stephanie Michon (2)
  Anne Brown (1) (5)
  Kathleen Wolff (1) (5)
  Laurie Shackleford (2)
  Elaine Boswell King (1) (5)
  Rebecca Pratt Gregory (1)
  Dianne Davis (1)
  Renee Stiles (2)
  Tebeb Gebretsadik (4)
  Kong Chen (10) (6) (7) (8)
  Russell Rothman (1) (2)
  James W Pichert (9)
  David Schlundt (11)
  Tom A Elasy (1) (12) (2) (3)
  
• 刊名：Implementation Science
• 出版年：2006
• 出版时间：December 2006
• 年：2006
• 卷：1
• 期：1
• 全文大小：244KB
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• 作者单位：Mary Margaret Huizinga (12) (2) (3)
  Ayumi Shintani (4)
  Stephanie Michon (2)
  Anne Brown (1) (5)
  Kathleen Wolff (1) (5)
  Laurie Shackleford (2)
  Elaine Boswell King (1) (5)
  Rebecca Pratt Gregory (1)
  Dianne Davis (1)
  Renee Stiles (2)
  Tebeb Gebretsadik (4)
  Kong Chen (10) (6) (7) (8)
  Russell Rothman (1) (2)
  James W Pichert (9)
  David Schlundt (11)
  Tom A Elasy (1) (12) (2) (3)
  
  12. VA National Quality Scholars Program, Nashville, TN, USA
  2. Division of General Internal Medicine and Public Health, Department of Medicine, Center for Health Services Research, Vanderbilt University Medical Center, Nashville, TN, USA
  3. VA Tennessee Valley Healthcare System, GRECC, Nashville, TN, USA
  4. Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA
  1. Diabetes Research and Training Center, Vanderbilt University Medical Center, Nashville, TN, USA
  5. School of Nursing, Vanderbilt University Medical Center, Nashville, TN, USA
  10. Energy Balance Laboratory, Vanderbilt University Medical Center, Nashville, TN, USA
  6. Division of Gastroenterology, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA
  7. Department of Biomedical Engineering, Vanderbilt University Medical Center, Nashville, TN, USA
  8. Department of Surgery, Vanderbilt University Medical Center, Nashville, TN, USA
  9. Center for Patient and Professional Advocacy, Vanderbilt University Medical Center, Nashville, TN, USA
  11. Department of Psychology, Vanderbilt University, Nashville, TN, USA
  

文摘

Background Diabetes is a common disease with self-management a key aspect of care. Large prospective trials have shown that maintaining glycated hemoglobin less than 7% greatly reduces complications but translating this level of control into everyday clinical practice can be difficult. Intensive improvement programs are successful in attaining control in patients with type 2 diabetes, however, many patients experience glycemic relapse once returned to routine care. This early relapse is, in part, due to decreased adherence in self-management behaviors. Objective This paper describes the design of the Glycemic Relapse Prevention study. The purpose of this study is to determine the optimal frequency of maintenance intervention needed to prevent glycemic relapse. The primary endpoint is glycemic relapse, which is defined as glycated hemoglobin greater than 8% and an increase of 1% from baseline. Methods The intervention consists of telephonic contact by a nurse practitioner with a referral to a dietitian if indicated. This intervention was designed to provide early identification of self-care problems, understanding the rationale behind the self-care lapse and problem solve to find a negotiated solution. A total of 164 patients were randomized to routine care (least intensive), routine care with phone contact every three months (moderate intensity) or routine care with phone contact every month (most intensive). Conclusion The baseline patient characteristics are similar across the treatment arms. Intervention fidelity analysis showed excellent reproducibility. This study will provide insight into the important but poorly understood area of glycemic relapse prevention.