|- candidate number||1660|
|- NTR Number||NTR476|
|- Date ISRCTN created||27-jan-2006|
|- date ISRCTN requested||18-nov-2005|
|- Date Registered NTR||14-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||Transmural Nutritional Support.|
|- Scientific Title||Transmural Nutritional Support.|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Malnutrition|
|- Inclusion criteria||1. Malnourished older patients (>60y); |
2. Admitted to the departments of internal medicine;
|- Exclusion criteria||1. Well-nourished; |
2. Descreased consciousness;
3. Inability to speak the Dutch language;
4. Expected Length of Hospital Stay <2 days.
|- mec approval received||no|
|- multicenter trial||no|
|- planned startdate ||1-jan-2006|
|- planned closingdate||31-dec-2009|
|- Target number of participants||164|
|- Interventions||Usual nutritional care vs. oral nutritional supplements from admission to hospital under 3 months after discharge.|
|- Primary outcome||1. 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 outcome||Changes in body weigth, body composition.|
|- Trial web site||N/A|
|- 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|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Objective(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.
Randomised Clinical Trial
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).
Standardised Oral Nutritional Support (600 kcal/day) from admission untill three months after discharge versus usual care
- 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.
- Changes in body-weight and composition between admission and at 3 months after discharge.
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.
Cost-effectiveness ratios and cost-utility ratios will be calculated with bootstrapping according to the bias corrected percentile method.
malnutrition, transmural, elderly, nutritional support
|- Main changes (audit trail)|
|- RECORD||15-sep-2005 - 7-mrt-2006|