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Nutritional Intervention in Hip Fracture Patients

Primary Purpose

Hip Fracture, Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Cubitan
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fracture focused on measuring Elderly, Osteoporosis, hip fracture, malnutrition, nutritional support

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Atrium MC
  • Maastricht University Hospital
  • Maaslandziekenhuis

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

C

I

Arm Description

Usual nurse and dietetic care

Intensive nutritional support composed of oral dietary supplement combined with dietetic counselling.

Outcomes

Primary Outcome Measures

Total length of hospital stay and rehabilitation clinics

Secondary Outcome Measures

Nutritional status, hip functionality, physical disability, fatigue, quality of life.
Cost questionnaire, informal care questionnaire.
Rate of complications

Full Information

First Posted
August 29, 2007
Last Updated
July 19, 2011
Sponsor
Maastricht University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT00523575
Brief Title
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

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Maastricht University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture, Malnutrition
Keywords
Elderly, Osteoporosis, hip fracture, malnutrition, nutritional support

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
C
Arm Type
No Intervention
Arm Description
Usual nurse and dietetic care
Arm Title
I
Arm Type
Experimental
Arm Description
Intensive nutritional support composed of oral dietary supplement combined with dietetic counselling.
Intervention Type
Dietary Supplement
Intervention Name(s)
Cubitan
Other Intervention Name(s)
Nutricia: Cubitan
Intervention Description
400 ml/d
Primary Outcome Measure Information:
Title
Total length of hospital stay and rehabilitation clinics
Time Frame
baseline, 3 months and 6 months after inclusion
Secondary Outcome Measure Information:
Title
Nutritional status, hip functionality, physical disability, fatigue, quality of life.
Time Frame
baseline, 3 months and 6 months after inclusion
Title
Cost questionnaire, informal care questionnaire.
Time Frame
baseline, 3 months and 6 months after inclusion
Title
Rate of complications
Time Frame
baseline, 3 months and 6 months after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
P C Dagnelie, PhD
Organizational Affiliation
Maastricht University - Faculty of Health Medicine and Life Sciences - Department of Epidemiologie
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
P LM Reijven, PhD
Organizational Affiliation
Maastricht University Hospital - Department of Dietetics & Maastricht University - Faculty of Health Medicine and Life Sciences - Department of Epidemiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atrium MC
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
Facility Name
Maastricht University Hospital
City
Maastricht
ZIP/Postal Code
6229 HA
Country
Netherlands
Facility Name
Maaslandziekenhuis
City
Sittard
ZIP/Postal Code
6131 BK
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
30204859
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.
Results Reference
derived
PubMed Identifier
22035956
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.
Results Reference
derived
PubMed Identifier
20423469
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.
Results Reference
derived

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Nutritional Intervention in Hip Fracture Patients

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