NCT01069497

Brief Summary

STUDY HYPOTHESIS : An infection prevention program adapted for the nursing home context can reduce by 5% the number of infections (urinary, upper and lower respiratory and gastrointestinal) in elderly residents in nursing homes. STUDY DESIGN : The proposal is for an interventional cluster (nursing home) study comprising 2 randomized groups: group 1 (interventional), comprising 25 nursing homes implementing a specific infection prevention program; and group 2 (control), 25 nursing homes continuing to implement their routine prevention measures.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2009

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 17, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

February 17, 2010

Status Verified

September 1, 2009

Enrollment Period

5 months

First QC Date

February 16, 2010

Last Update Submit

February 16, 2010

Conditions

Keywords

Infection controlUrinary Tract InfectionsRespiratory Tract Infections

Outcome Measures

Primary Outcomes (1)

  • Number of infections (urinary, upper and lower respiratory and gastrointestinal) in elderly residents in nursing homes

    every month

Secondary Outcomes (3)

  • Number of death

    every month

  • Number of hospitalizations

    every month

  • Number of of prescriptions for antimicrobials

    every month

Study Arms (2)

Intervention Nursing Homes

EXPERIMENTAL

Comprising 24 nursing homes implementing a specific infection prevention program

Other: Prevention of infections program

Usual care Nursing Homes

NO INTERVENTION

Interventions

The intervention mainly involves implementing urinary, respiratory and gastrointestinal infection prevention measures. Study nursing home medical coordinators will be in charge of training their own teams. For this, they will be provided with: * a slide-show of recommendations (commented by an expert), * recommendations guides (on paper and on computer) to be shown to their teams. Means will be provided to the intervention nursing homes : Hydro-alcoholic solutions, disinfectant detergent-impregnated tissues, mouth care kits, tec.

Intervention Nursing Homes

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Nursing homes which contain a medical coordinator and at least one nurse and/or nursing auxiliary.
  • Nursing Homes located in France (North-West)
  • All the residents present or entering the facility during the study period

You may not qualify if:

  • Nursing homes where a prevention program has already been implemented

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Chami K, Gavazzi G, Bar-Hen A, Carrat F, de Wazieres B, Lejeune B, Armand N, Rainfray M, Hajjar J, Piette F, Rothan Tondeur M. A short-term, multicomponent infection control program in nursing homes: a cluster randomized controlled trial. J Am Med Dir Assoc. 2012 Jul;13(6):569.e9-17. doi: 10.1016/j.jamda.2012.04.008. Epub 2012 Jun 7.

MeSH Terms

Conditions

Urinary Tract InfectionsRespiratory Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRespiratory Tract Diseases

Study Officials

  • Monique Rothan Tondeur, PhD

    ORIG, EHESP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 16, 2010

First Posted

February 17, 2010

Study Start

November 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

February 17, 2010

Record last verified: 2009-09