Nutritional Intervention in Hip Fracture Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Hip Fracture, Malnutrition

Intervention / Treatment
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* Dietary Supplement: Cubitan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: C<br>Usual nurse and dietetic care | |
| Experimental: I<br>Intensive nutritional support composed of oral dietary supplement combined with dietetic counselling. | Dietary Supplement: Cubitan<br>* 400 ml/d<br>* Other names: Nutricia: Cubitan;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elderly, Osteoporosis, hip fracture, malnutrition, nutritional support