Nutritional Intervention in Hip Fracture Patients
Effectiveness and Cost-effectiveness of Nutritional Screening and Intervention in Elderly Subjects After Hip Fracture
2 other identifiers
interventional
210
1 country
3
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2007
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 29, 2007
CompletedFirst Posted
Study publicly available on registry
August 31, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedJuly 20, 2011
July 1, 2011
2.3 years
August 29, 2007
July 19, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total length of hospital stay and rehabilitation clinics
baseline, 3 months and 6 months after inclusion
Secondary Outcomes (3)
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 Arms (2)
C
NO INTERVENTIONUsual nurse and dietetic care
I
EXPERIMENTALIntensive nutritional support composed of oral dietary supplement combined with dietetic counselling.
Interventions
Eligibility Criteria
You may qualify if:
- Admission to one of the participating hospitals because of a proximal femur fracture
- Age 55 years and older
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Atrium MC
Heerlen, 6419 PC, Netherlands
Maastricht University Hospital
Maastricht, 6229 HA, Netherlands
Maaslandziekenhuis
Sittard, 6131 BK, Netherlands
Related Publications (3)
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.
PMID: 30204859DERIVEDBreedveld-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.
PMID: 22035956DERIVEDWyers 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.
PMID: 20423469DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 29, 2007
First Posted
August 31, 2007
Study Start
August 1, 2007
Primary Completion
December 1, 2009
Study Completion
June 1, 2010
Last Updated
July 20, 2011
Record last verified: 2011-07