Nursing Homes Study of Fall Risk Assessment Oriented to Intervention (EMERCOIR)
| Tracking Information | |||||
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| First Received Date ICMJE | April 27, 2009 | ||||
| Last Updated Date | June 12, 2013 | ||||
| Start Date ICMJE | May 2009 | ||||
| Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Number of fallers [ Time Frame: one year ] [ Designated as safety issue: No ] People who at least have one fall during the follow-up period. Fall:unexpected event in which the participants come to rest on the ground, floor, or lower level |
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| Original Primary Outcome Measures ICMJE |
Number of fallers [ Time Frame: one year ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00888953 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Nursing Homes Study of Fall Risk Assessment Oriented to Intervention | ||||
| Official Title ICMJE | Estudio de Medida Del Riesgo de Caídas Orientada a la Intervención en Residencias | ||||
| Brief Summary | The aim of the study is to establish the impact of a falls screening questionnaire in the adoption of preventive interventions and eventually in the reduction of falls and its consequences in elder people living in nursing homes. |
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| Detailed Description | Falls are the most frequent accidents in nursing homes, affecting more than a third of residents each year. Up to 10% of fallers require hospitalization or suffer a fracture. Psychological consequences affects between 20 and 80% of fallers, which suffer a lack of self-confidence that leads to reduction of activities and an increase of the dependence in activities of daily living. Not all the residents have the same risk, and each person can have more than one risk factor that can be identified (previous falls, self confidence, weakness, gait disorders, dizziness, cognitive impairment, etc). Identification of risk factors is the first step to reduce falls, but is not enough by itself. For this reason, interventions directed towards the correction of identified risk factors are required. In this setting, multifactorial interventions are the most successful to reduce falls numbers and its consequences. As individual randomization of residents presents important inconveniences (group contamination, control arm residents could felt discriminated), we will randomized nursing homes to each group. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 331 | ||||
| Completion Date | April 2012 | ||||
| Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 65 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Spain | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00888953 | ||||
| Other Study ID Numbers ICMJE | FICE09041, PI08/90162, 645H | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Fundacio Institut Catala de l'Envelliment | ||||
| Study Sponsor ICMJE | Fundacio Institut Catala de l'Envelliment | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Fundacio Institut Catala de l'Envelliment | ||||
| Verification Date | June 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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