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