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.
ID
Bron
Verkorte titel
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Changes in ADL, functional limitations, muscle strength, quality of life;<br>
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; <br>
3. Economic evaluation.
Achtergrond van het onderzoek
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.
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
Doel van het onderzoek
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.
Onderzoeksproduct en/of interventie
Usual nutritional care vs. oral nutritional supplements from admission to hospital under 3 months after discharge.
Publiek
P.O. Box 7057
M.A.E. Bokhorst - de van der Schueren, van
De Boelelaan 1117
Amsterdam 1007 MB
The Netherlands
m.vanbokhorst@vumc.nl
Wetenschappelijk
P.O. Box 7057
M.A.E. Bokhorst - de van der Schueren, van
De Boelelaan 1117
Amsterdam 1007 MB
The Netherlands
m.vanbokhorst@vumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Malnourished older patients (>60y);
2. Admitted to the departments of internal medicine;
3. Gastroenterology;
4. Nephrology;
5. Rheumatology;
6. Dermatology.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Well-nourished;
2. Descreased consciousness;
3. Inability to speak the Dutch language;
4. Expected Length of Hospital Stay <2 days.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL436 |
| NTR-old | NTR476 |
| Ander register | : N/A |
| ISRCTN | ISRCTN29617677 |