Hyponatremia in the Prevention of Hospitalized Patients Falls

Status Completed

Clinical Trial Summary

Cross ecological quasi-experimental study to assess effectiveness of early intervention in the diagnosis and treatment of hyponatremia in the prevention of hospitalized patients´ falls.

Clinical Trial Description

Effectiveness of early intervention in the diagnosis and treatment of hyponatremia in the prevention of hospitalized patients´ falls.

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03265691
Study type	Interventional
Source	Hospital General Universitario Gregorio Marañon
Contact
Status	Completed
Phase	N/A
Start date	December 2014
Completion date	December 2016

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Hyponatremia in the Prevention of Hospitalized Patients Falls — PRECAHI

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms