Hyponatremia in the Prevention of Hospitalized Patients Falls
NCT ID: NCT03265691
Last Updated: 2017-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
124 participants
INTERVENTIONAL
2014-12-31
2016-12-31
Brief Summary
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Detailed Description
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Aims:
1. To assess the effectiveness of corrective activity of hyponatremia in falls reducing incidence.
2. To assess the cost-effectiveness ratio of the two proposed strategies: conventional treatment versus early intervention.
Cross ecological quasi-experimental study. The project will take place in Gregorio Marañón Hospital (Madrid, Spain) in the following inpatient adult Units: Neurology, Rehabilitation 1, Geriatrics, Internal Medicine (Group A), Cardiology, Rehabilitation 2, Gastroenterology, Neurosurgery and Oncology (Group B).
The estimated sample size for a confidence level of 95% (α = 0.05) and power of 90% (β = 0.010), taking into account a decrease in the incidence of falls of 20% restocking losses, is 124 patients per group (ie, the 124 patients receiving regular performance \*\* and 124 patients receiving the experimental intervention \*, if necessary, by participant Unit).
Data collection: In each of the study participants Units both interventions will be held. First the participants Units have been randomized in two groups (Group A: Neurology, Rehabilitation 1, Geriatrics, Internal Medicine; Group B: Cardiology, Rehabilitation 2, Gastroenterology, Neurosurgery and Oncology). All patients hospitalized in these Units will be potentially included. First of all, collaborators will give them an informed consent to ask for their participation.
The interventions are:
* Experimental intervention: early diagnosis, treatment of hyponatremia until resolution and valuation according to the Dynamic Gait Index test. Duration: 6 months
* Habitual action: the usual pattern of work will be performed in all patients who enter. Duration: 6 months.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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Early hyponatremia diagnosis and treatment
The early diagnosis of hiponatremia is not a stándar procedure. In the experimental arm, hyponatremia will be diagnosed and treated early.
Early detection and treatment of hyponatremia
In the experimental group, hyponatremia will be diagnosed and treated early. Therefore, the researchers will review the patients' sodium levels at admission and throughout their stay.
No Intervention (SOC)
Usual pattern of work will be performed in all patients who enter in Hospital.
No intervention
Usual pattern of work will be performed in all patients who enter in Hospital. Duration: 6 months.
No interventions assigned to this group
Interventions
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Early detection and treatment of hyponatremia
In the experimental group, hyponatremia will be diagnosed and treated early. Therefore, the researchers will review the patients' sodium levels at admission and throughout their stay.
No Intervention (SOC)
Usual pattern of work will be performed in all patients who enter in Hospital.
Eligibility Criteria
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Inclusion Criteria
* Admitted to a participating study unit
* Wish to participate in the study and signature of informed consent.
Exclusion Criteria
* Deterioration of the patient's condition to severe or extremely painful
65 Years
ALL
No
Sponsors
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Fundación Mutua Madrileña
OTHER
Mª del Carmen Lobo Rodríguez
OTHER
Responsible Party
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Mª del Carmen Lobo Rodríguez
Msc Nurse Research
Principal Investigators
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Locations
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Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Countries
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Other Identifiers
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V01_Enf
Identifier Type: -
Identifier Source: org_study_id
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