Nutritional Intervention in Hip Fracture Patients
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:
- Does nutritional intervention reduce total length-of-stay?
- Is nutritional intervention cost-effective?
- 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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effectiveness and Cost-effectiveness of Nutritional Screening and Intervention in Elderly Subjects After Hip Fracture|
- Total length of hospital stay and rehabilitation clinics [ Time Frame: baseline, 3 months and 6 months after inclusion ] [ Designated as safety issue: No ]
- Nutritional status, hip functionality, physical disability, fatigue, quality of life. [ Time Frame: baseline, 3 months and 6 months after inclusion ] [ Designated as safety issue: No ]
- Cost questionnaire, informal care questionnaire. [ Time Frame: baseline, 3 months and 6 months after inclusion ] [ Designated as safety issue: No ]
- Rate of complications [ Time Frame: baseline, 3 months and 6 months after inclusion ] [ Designated as safety issue: No ]
|Study Start Date:||August 2007|
|Study Completion Date:||June 2010|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
No Intervention: C
Usual nurse and dietetic care
Intensive nutritional support composed of oral dietary supplement combined with dietetic counselling.
Dietary Supplement: Cubitan
Other Name: Nutricia: Cubitan
Please refer to this study by its ClinicalTrials.gov identifier: NCT00523575
|Heerlen, Netherlands, 6419 PC|
|Maastricht University Hospital|
|Maastricht, Netherlands, 6229 HA|
|Sittard, Netherlands, 6131 BK|
|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|