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The effects and costs of cranberry use to prevent symptomatic urinary tract intections in nursing home residents.


- candidate number3161
- NTR NumberNTR1266
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-apr-2008
- Secondary IDs80-82310-98-08503 ZonMw doelmatigheid
- Public TitleThe effects and costs of cranberry use to prevent symptomatic urinary tract intections in nursing home residents.
- Scientific TitleThe effects and costs of cranberry use to prevent symptomatic urinary tract infections (UTI) in nursing home residents.
- ACRONYMCRANBERRY
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedUrinary tract infections, Prevention, Cranberry
- Inclusion criteria1. Age >= 65 jaar
2. Life expectancy > 1 month
- Exclusion criteria1. Coumarine users
2. Acute illness
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2008
- planned closingdate1-feb-2011
- Target number of participants1000
- Interventions- Intervention (n=500): 2x dd Cranberry during 1 year.
- Controles (n=500): 2x dd Placebo during 1 year.
- Primary outcome1. Time to first symtomatic UTI
2. number of symptomatic UITs per included resident
3. Quality of life (EQ-5D)
4. Care dependency (Care dependency scale)
5. Resistence patterns of microbial agents
6. Compliance
7. Side effects
8. Economic evaluation: cost effectivity analysis (cost per prevented UTI) and cost-utility analysis (costs per QUALY)
- Secondary outcomeN/A
- TimepointsAt start study, after 6 and 12 months.
During UTI 3 times a week for 3 weeks.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. M.A.A. Caljouw
- CONTACT for SCIENTIFIC QUERIESDr. M.A.A. Caljouw
- Sponsor/Initiator Leiden University Medical Center (LUMC), Department of Public Health and Primary Care
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, Springfield Nutraceuticals BV
- PublicationsN/A
- Brief summaryObjectives/research questions.
To assess the effects and costs of cranberry use to prevent symptomatic UTIs in nursing home residents.

Study design.
Double-blinded randomised placebo-controlled multi-centre intervention trial.
Study population and sample size.
All nursing home residents ≥ 65 years, except coumarin users, stratified by risk of symptomatic UTI (high versus low). The group with high risk of UTI includes nursing home residents with long-term catheterisation (> 1 month) and/or diabetes mellitus and/or a history of at least one treated symptomatic UTI in the preceding year.
To detect a 50% reduction in cumulative incidence of symptomatic UTIs, 1000 residents will be enrolled within a period of three months.

Eligibility Criteria.
All nursing home residents ≥ 65 years and a life expectancy > 1 month are eligible, except those using coumarin.
Study procedures.
Intervention: Cranberry capsule/sachet or placebo (both administered twice daily) during one year. The Cranberry capusule/sachet contains 1.8% proanthocyanidins (PACS)
The study does not interfere with standard care. Diagnostics and treatment will occur in accordance with current clinical guidelines.
Outcome measures.
Effects: time to first symptomatic UTI, number of symptomatic UTIs per included resident, quality of life, care dependency, compliance, side effects, medical consumption, resistance patterns of etiologic microbial agents, and costs.
The economic evaluation will include a cost-effectiveness analysis (costs per prevented UTI) and a cost-utility analysis (costs per QALY).

Analysis.
All data-analysis will be done on the basis of intention-to-treat analysis. Descriptive statistics, multivariate Cox-analyses and multivariate linear mixed models will be used.

Time schedule.
M 1-7 preparation, M 8-10 inclusion of residents, M 8-22 intervention period, M 23-36 analyses and publication.

- Main changes (audit trail)
- RECORD1-apr-2008 - 16-jun-2008


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