Clinical trial NCT00523575: Nutritional Intervention in Hip Fracture Patients
Official title: Effectiveness and Cost-effectiveness of Nutritional Screening and Intervention in Elderly Subjects After Hip Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fracture
Malnutrition
Keywords: Elderly
Osteoporosis
hip fracture
malnutrition
nutritional support
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2007-08-31
Enrollment: 210
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Total length of hospital stay and rehabilitation clinics
timeFrame: baseline, 3 months and 6 months after inclusion
Secondary outcomes:
measure: Nutritional status, hip functionality, physical disability, fatigue, quality of life.
timeFrame: baseline, 3 months and 6 months after inclusion
measure: Cost questionnaire, informal care questionnaire.
timeFrame: baseline, 3 months and 6 months after inclusion
measure: Rate of complications
timeFrame: baseline, 3 months and 6 months after inclusion
Other outcomes:
Locations:
city: Heerlen
country: Netherlands
facility: Atrium MC
city: Maastricht
country: Netherlands
facility: Maastricht University Hospital
city: Sittard
country: Netherlands
facility: Maaslandziekenhuis
Study officials:
affiliation: Maastricht University - Faculty of Health Medicine and Life Sciences - Department of Epidemiologie
name: P C Dagnelie, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Hospital - Department of Dietetics & Maastricht University - Faculty of Health Medicine and Life Sciences - Department of Epidemiology
name: P LM Reijven, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wyers CE, Reijven PLM, Breedveld-Peters JJL, Denissen KFM, Schotanus MGM, van Dongen MCJM, Eussen SJPM, Heyligers IC, van den Brandt PA, Willems PC, van Helden S, Dagnelie PC. Efficacy of Nutritional Intervention in Elderly After Hip Fracture: A Multicenter Randomized Controlled Trial. J Gerontol A Biol Sci Med Sci. 2018 Sep 11;73(10):1429-1437. doi: 10.1093/gerona/gly030.
citation: Breedveld-Peters JJ, Reijven PL, Wyers CE, van Helden S, Arts JJ, Meesters B, Prins MH, van der Weijden T, Dagnelie PC. Integrated nutritional intervention in the elderly after hip fracture. A process evaluation. Clin Nutr. 2012 Apr;31(2):199-205. doi: 10.1016/j.clnu.2011.10.004. Epub 2011 Oct 28.
citation: Wyers CE, Breedveld-Peters JJ, Reijven PL, van Helden S, Guldemond NA, Severens JL, Verburg AD, Meesters B, van Rhijn LW, Dagnelie PC. Efficacy and cost-effectiveness of nutritional intervention in elderly after hip fracture: design of a randomized controlled trial. BMC Public Health. 2010 Apr 27;10:212. doi: 10.1186/1471-2458-10-212.