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Effectiviteit en kosteneffectiviteit van de behandeling van ondervoeding na screening in de eerstelijns- en thuiszorg.


- candidate number5733
- NTR NumberNTR1808
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-mei-2009
- Secondary IDs312843 Ministry of VWS
- Public TitleEffectiviteit en kosteneffectiviteit van de behandeling van ondervoeding na screening in de eerstelijns- en thuiszorg.
- Scientific TitleEffectiveness and efficiency of treatment for undernutrition after screening in primary care.
- ACRONYMViE-study (Voeding in Eerstelijn)
- hypothesisThe following research questions will be determined:
1. What is the effect of an nutritional intervention compared to usual care in undernourished patients of 65 years in general practice or using home care?
2. What is the cost effectiveness of an nutritional intervention compared to usual care in undernourished patients of 65 years in general practice or using home care?
- Healt Condition(s) or Problem(s) studiedMalnutrition
- Inclusion criteria1. Undernourished;
2. 65 years or older.
- Exclusion criteria1. Living in a nursing or residential home;
2. Cognitive impairment;
3. Treatment of a dietitian at baseline;
4. Cannot stand;
5. Having anorexia or boulimia nervosa;
6. Terminal patients;
7. BMI < 28 at baseline;
8. Cannot speak Dutch;
9. <75% follow-up.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2009
- planned closingdate1-jul-2010
- Target number of participants200
- InterventionsThe intervention group will have a treatment for undernutrition by a dietitian. The control group only receive a calcium and vitamin D supplement (1000 mg calcium and 800 EI vitamin D3).
- Primary outcomePrimary outcomes are weight (kg) and utility (measured with EQ-5D).
- Secondary outcome1. Mid-upper arm circumference;
2. Fat free mass;
3. Hand grip strength;
4. Quality of life;
5. Fysical functioning;
6. Fysical activity;
7. Protein/energy intake;
8. Suppletion vitamin D and calcium.
- TimepointsMeasurments will take place at baseline, after 3 months and after 6 months follow-up.
- Trial web sitewww.stuurgroepondervoeding.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIES J. Schilp
- CONTACT for SCIENTIFIC QUERIES M. Visser
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Ministry of Health, Welfare and Sports (VWS)
- PublicationsN/A
- Brief summaryMalnutrition is an extensive problem in Dutch health care; it lead to high costs of care and higher mortality. Often, malnutrition is not early recognized and treated. In primary care and home care is less attention for screening and treatment of malnutrition. The primary objective of this study is to determine the effectiveness and efficiency of treatment for malnutrition in people aged 60 years and older after screening in primary care. The study is a Randomized Controlled Trial and the study population are community living malnourished older people. The interventiongroup will have a nutritional intervention and will be compared to the controlgroep. Both groups will prescribed a vitamin D and calcium supplement. Primary study parameters are weight and utility.
- Main changes (audit trail)
- RECORD11-mei-2009 - 30-sep-2009


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