NCT03265691

Hyponatremia in the Prevention of Hospitalized Patients Falls

Effectiveness of Early Intervention in the Diagnosis and Treatment of Hyponatremia in the Prevention of Hospitalized Patients Falls

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Mª del Carmen Lobo Rodríguez · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hyponatremia
• Accidental Falls

Interventions

Type	Name	Description
OTHER	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.
OTHER	No Intervention (SOC)	Usual pattern of work will be performed in all patients who enter in Hospital.

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2017-08-29
• Last updated: 2017-08-29

Locations

1 site across 1 country: Spain