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Randomized Controlled Trial to the effectiveness of Oral Nutrition Supplementation during Medical Rounds in the Hospital.


- candidate number8496
- NTR NumberNTR2535
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-sep-2010
- Secondary IDsNL31647.075.10 METC Deventer Ziekenhuis
- Public TitleRandomized Controlled Trial to the effectiveness of Oral Nutrition Supplementation during Medical Rounds in the Hospital.
- Scientific TitleRandomized Controlled Trial to the effectiveness of Oral Nutrition Supplementation during Medical Rounds in the Hospital.
- ACRONYM
- hypothesisONS during medical rounds improves the intake in malnourished patients.
- Healt Condition(s) or Problem(s) studiedMalnutrition, Oral nutritional support, Medical rounds
- Inclusion criteriaAdult malnourised patients in Deventer Hospital diagnosed with SNAQ screening tool or diagnosed by physician and treated by oral nutritional supplementation.
- Exclusion criteria1. Hospital wards: Peadiatrics, obstretics, ICU, ER, dialysis, chemotherapy, X-ray;
2. Patients with enteral of parenteral nutrition;
3. Patients with swallow disabilities;
4. Patients with (pre)dialysis therapy.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 20-apr-2010
- planned closingdate31-dec-2010
- Target number of participants300
- Interventions1. ONS in between meals twice a day a whole bottle of 125 ml at 10.00 and 15.00;
2. ONS during medical rounds twice a day a whole bottle of 125 ml at 12.00 and 17.00;
3. ONS during medical rounds four times a day half a dosis (e.g. 62 ml) at 8.00-12.00-17.00- 20.00.

All three groups use ONS during hospital stay or as long as ONS is indicated (max. 30 days).

Intake in ml will be assessed to evaluate proportion of patients who received their treament goal (e.g. 75% intake of prescription).
- Primary outcomeProportion patients who recieved their treatment goal.
- Secondary outcomeIntake in ml. Nurses and food assistants read the amount of ONS left in the bottles. Interrater reliability is evaluated with ICC.
- TimepointsMoments of consumption. Patients have 1 hour to finish their ONS.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES G.H. Berg, van den
- CONTACT for SCIENTIFIC QUERIES G.H. Berg, van den
- Sponsor/Initiator Deventer Ziekenhuis
- Funding
(Source(s) of Monetary or Material Support)
Deventer Ziekenhuis
- PublicationsN/A
- Brief summaryRandomised Controlled Trial to the effectiveness of Oral Nutrition Supplementation (ONS) during Medical Rounds in the Hospital. The aim of this study is to compare the effect of ONS during medical rounds on nutrient intake in patients who suffer severe disease related malnutrition and evaluate the effect of low doses/high frequency on this nutrient intake. Therefore 300 patients from six hospital wards (internal and surgical) will be allocated at random in one of three treatment groups: 1. ONS in between meals twice a day a whole bottle of 125 ml at 10.00 and 15.00, or 2. ONS during medical rounds twice a day a whole bottle of 125 ml at 12.00 and 17.00 or 3. ONS during medical rounds four times a day half a dosis of 62 ml at 8.00-12.00-17.00-20.00 hour). Follow-up is use of ONS during hospital stay or as long as ONS is indicated (max. 30 days). Primary endpoint is percentage patients who receive their treatment goal (e.g. 75% intake). Secondary endpoint is intake of ONS in ml.
- Main changes (audit trail)
- RECORD25-sep-2010 - 19-nov-2010


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