Nutritional Intervention in Hip Fracture Patients

July 19, 2011 updated by: Maastricht University Medical Center

Effectiveness and Cost-effectiveness of Nutritional Screening and Intervention in Elderly Subjects After Hip Fracture

Hip fractures are highly prevalent and are expected to increase due to the ageing population. Malnutrition is often present in these patients and is associated with prolonged convalescence, lower mobility, lower mental function, lower quality of life and higher complication rate. Nutritional intervention starting soon after hospital admission might reduce complication rate and total length-of-stay by improving nutritional and functional status. Research questions are:

  1. Does nutritional intervention reduce total length-of-stay?
  2. Is nutritional intervention cost-effective?
  3. Can nutritional screening contribute to targeting of nutritional intervention, and thereby reduce costs without loss of effectiveness?

Patients randomized to the intervention group will receive oral nutritional supplements (protein and energy enriched) and regular dietetic counselling during hospitalisation and after discharge at patients' homes for 3 months. Patients in the control group will receive usual nurse and dietetic care. Outcome measurements will be taken at baseline, 3 months and 6 months after inclusion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Heerlen, Netherlands, 6419 PC
        • Atrium MC
      • Maastricht, Netherlands, 6229 HA
        • Maastricht University Hospital
      • Sittard, Netherlands, 6131 BK
        • Maaslandziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Admission to one of the participating hospitals because of a proximal femur fracture
  • Age 55 years and older

Exclusion Criteria:

  • Periprosthetic or pathologic fracture
  • Diseases of bone metabolism, e.g. Paget, primary/secondary bone tumors, hyperparathyroidism, M. Kahler
  • Life expectation of less than one year due to underlying disease (e.g. cancer)
  • Presence of dementia or other severely impaired cognitive function
  • Inability to communicate in Dutch language
  • Nutritional intervention prior to admission
  • Patients who are bedridden
  • Patients who are too ill or for any other reason not able to participate adequately in follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: C
Usual nurse and dietetic care
Experimental: I
Intensive nutritional support composed of oral dietary supplement combined with dietetic counselling.
Dietary supplement: Cubitan
400 ml/d
Other Names:
  • Nutricia: Cubitan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total length of hospital stay and rehabilitation clinics
Time Frame: baseline, 3 months and 6 months after inclusion
baseline, 3 months and 6 months after inclusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Nutritional status, hip functionality, physical disability, fatigue, quality of life.
Time Frame: baseline, 3 months and 6 months after inclusion
baseline, 3 months and 6 months after inclusion
Cost questionnaire, informal care questionnaire.
Time Frame: baseline, 3 months and 6 months after inclusion
baseline, 3 months and 6 months after inclusion
Rate of complications
Time Frame: baseline, 3 months and 6 months after inclusion
baseline, 3 months and 6 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

  • Principal Investigator: P C Dagnelie, PhD, Maastricht University - Faculty of Health Medicine and Life Sciences - Department of Epidemiologie
  • Principal Investigator: P LM Reijven, PhD, Maastricht University Hospital - Department of Dietetics & Maastricht University - Faculty of Health Medicine and Life Sciences - Department of Epidemiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

August 29, 2007

First Submitted That Met QC Criteria

August 30, 2007

First Posted (Estimate)

August 31, 2007

Study Record Updates

Last Update Posted (Estimate)

July 20, 2011

Last Update Submitted That Met QC Criteria

July 19, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC 06-3-098
  • ZonMw 80-007022-98-07510

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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