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Clinical Trials/NCT00523575
NCT00523575
Completed
Not Applicable

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

Maastricht University Medical Center3 sites in 1 country210 target enrollmentAugust 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hip Fracture
Sponsor
Maastricht University Medical Center
Enrollment
210
Locations
3
Primary Endpoint
Total length of hospital stay and rehabilitation clinics
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
August 2007
End Date
June 2010
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Total length of hospital stay and rehabilitation clinics

Time Frame: baseline, 3 months and 6 months after inclusion

Secondary Outcomes

  • Nutritional status, hip functionality, physical disability, fatigue, quality of life.(baseline, 3 months and 6 months after inclusion)
  • Cost questionnaire, informal care questionnaire.(baseline, 3 months and 6 months after inclusion)
  • Rate of complications(baseline, 3 months and 6 months after inclusion)

Study Sites (3)

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