title: A randomized controlled trial to prevent glycemic relapse in longitudinal diabetes care: study protocol (NCT00362193).
abstract: 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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Diabetes Research and Training Center, Vanderbilt University Medical Center, Nashville, TN, USA. mary.margaret.huizinga@vanderbilt.edu
authors.forename: Mary Margaret
authors.initials: MM
authors.lastname: Huizinga
authors.forename: Ayumi
authors.initials: A
authors.lastname: Shintani
authors.forename: Stephanie
authors.initials: S
authors.lastname: Michon
authors.forename: Anne
authors.initials: A
authors.lastname: Brown
authors.forename: Kathleen
authors.initials: K
authors.lastname: Wolff
authors.forename: Laurie
authors.initials: L
authors.lastname: Shackleford
authors.forename: Elaine Boswell
authors.initials: EB
authors.lastname: King
authors.forename: Rebecca Pratt
authors.initials: RP
authors.lastname: Gregory
authors.forename: Dianne
authors.initials: D
authors.lastname: Davis
authors.forename: Renee
authors.initials: R
authors.lastname: Stiles
authors.forename: Tebeb
authors.initials: T
authors.lastname: Gebretsadik
authors.forename: Kong
authors.initials: K
authors.lastname: Chen
authors.forename: Russell
authors.initials: R
authors.lastname: Rothman
authors.forename: James W
authors.initials: JW
authors.lastname: Pichert
authors.forename: David
authors.initials: D
authors.lastname: Schlundt
authors.forename: Tom A
authors.initials: TA
authors.lastname: Elasy