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Open Access Study protocol

Efficacy and cost-effectiveness of nutritional intervention in elderly after hip fracture: design of a randomized controlled trial

Caroline E Wyers1*, José JL Breedveld-Peters1, Petronella LM Reijven12, Svenjhalmar van Helden3, Nick A Guldemond4, Johan L Severens5, Aart D Verburg6, Berry Meesters7, Lodewijk W van Rhijn4 and Pieter C Dagnelie1

Author Affiliations

1 Department of Epidemiology, Maastricht University Medical Centre, PO Box 616, 6200 MD Maastricht, The Netherlands

2 Department of Dietetics, Maastricht University Medical Centre, PO Box 5800, 6202 AZ Maastricht, The Netherlands

3 Department of Trauma surgery, Maastricht University Medical Centre, PO Box 5800, 6202 AZ Maastricht, The Netherlands

4 Department of Orthopaedic Surgery, Maastricht University Medical Centre, PO Box 5800, 6202 AZ Maastricht, The Netherlands

5 Department of Health Organization, Policy and Economics, Maastricht University Medical Centre, and Institute of Health Policy and Management, Erasmus University Rotterdam, PO Box 616, 6200 MD Maastricht, The Netherlands

6 Department of Orthopaedic Surgery, Orbis Medical Centre, PO Box 5500, 6130 MB Sittard, The Netherlands

7 Department of Surgery, Atrium Medical Centre, PO Box 4446, 6401 CX Heerlen, The Netherlands

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BMC Public Health 2010, 10:212  doi:10.1186/1471-2458-10-212

Published: 27 April 2010

Abstract

Background

Hip fracture patients often have an impaired nutritional status at the time of fracture, which can result in a higher complication rate, prolonged rehabilitation time and increased mortality. A study was designed to evaluate the effect of nutritional intervention on nutritional status, functional status, total length of stay, postoperative complications and cost-effectiveness.

Methods

Open-labelled, multi-centre, randomized controlled trial in hip fracture patients aged 55 years and above. The intervention group receives dietetic counselling (by regular home visits and telephone calls) and oral nutritional supplementation for three months after surgery. The control group receives usual dietetic care as provided by the hospital. Outcome assessment is performed at three and six months after hip fracture.

Discussion

Patient recruitment has started in July 2007 and has ended in December 2009. First results are expected in 2011.

Trial registration

ClinicalTrials.gov NCT00523575