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Transmural Nutritional Support.


- candidate number1660
- NTR NumberNTR476
- ISRCTNISRCTN29617677
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR14-sep-2005
- Secondary IDsN/A 
- Public TitleTransmural Nutritional Support.
- Scientific TitleTransmural Nutritional Support.
- ACRONYMN/A
- hypothesisTo study the cost-effectiveness of transmural nutritional support (from admission to hospital until 3 months after discharge) in malnourished elderly patients, compared to usual care.
- Healt Condition(s) or Problem(s) studiedMalnutrition
- Inclusion criteria1. Malnourished older patients (>60y);
2. Admitted to the departments of internal medicine;
3. Gastroenterology;
4. Nephrology;
5. Rheumatology;
6. Dermatology.
- Exclusion criteria1. Well-nourished;
2. Descreased consciousness;
3. Inability to speak the Dutch language;
4. Expected Length of Hospital Stay <2 days.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-jan-2006
- planned closingdate31-dec-2009
- Target number of participants164
- InterventionsUsual nutritional care vs. oral nutritional supplements from admission to hospital under 3 months after discharge.
- Primary outcome1. Changes in ADL, functional limitations, muscle strength, quality of life;
2. Length of hospital stay, number of re-admissions to hospital, complication rate, number of medical prescriptions and number of doctor contacts within the first 3 months after discharge;
3. Economic evaluation.
- Secondary outcomeChanges in body weigth, body composition.
- Timepoints
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES M.A.E. Bokhorst - de van der Schueren, van
- CONTACT for SCIENTIFIC QUERIES M.A.E. Bokhorst - de van der Schueren, van
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryObjective(s) / research question(s):
To study the cost-effectiveness of transmural nutritional support (from admission to hospital until 3 months after discharge) in malnourished elderly patients, compared to usual care.
Study design:
Randomised Clinical Trial
Study population:
Hospitalised patients of 60 years and over admitted to the wards of mixed internal medicine with a BMI<20 and/or involuntary weight loss >10%(= malnourished).
Intervention:
Standardised Oral Nutritional Support (600 kcal/day) from admission untill three months after discharge versus usual care
Outcome measures:
Primary:

- Changes in ADL, functional limitations, muscle strength and quality of life between admission and at 3 months after discharge.
- Length of hospital stay, number of re-admissions to hospital, complication rate, number of medical prescriptions and number of doctor contacts within the first 3 months after discharge.
Secondary:
- Changes in body-weight and composition between admission and at 3 months after discharge.
Power/data analysis:
100 Control and 100 intervention patients are needed in order to detect a clinically relevant difference of 20% in functional and nutritional status or a difference in complication rates of 40% (control) vs. 20% (intervention). Intention-to-treat analysis. Multivariate techniques to test differences between intervention and control group. Regression analysis to test the relative contribution of the intervention on the outcome parameters.
Economic evaluation:
Cost-effectiveness ratios and cost-utility ratios will be calculated with bootstrapping according to the bias corrected percentile method.
Keywords:
malnutrition, transmural, elderly, nutritional support
- Main changes (audit trail)
- RECORD15-sep-2005 - 7-mrt-2006


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