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Clinical Trials/NCT03265691
NCT03265691
Completed
N/A

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

Mª del Carmen Lobo Rodríguez1 site in 1 country124 target enrollmentDecember 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hyponatremia
Sponsor
Mª del Carmen Lobo Rodríguez
Enrollment
124
Locations
1
Primary Endpoint
To evaluate the effectiveness of treatment of hyponatremia in reducing the incidence of falls.
Status
Completed
Last Updated
8 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
December 2014
End Date
December 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Mª del Carmen Lobo Rodríguez
Responsible Party
Sponsor Investigator
Principal Investigator

Mª del Carmen Lobo Rodríguez

Msc Nurse Research

Hospital General Universitario Gregorio Marañon

Eligibility Criteria

Inclusion Criteria

  • Age \>65 years
  • Admitted to a participating study unit
  • Wish to participate in the study and signature of informed consent.

Exclusion Criteria

  • Transfer of the patient to a unit not included in the study
  • Deterioration of the patient's condition to severe or extremely painful

Outcomes

Primary Outcomes

To evaluate the effectiveness of treatment of hyponatremia in reducing the incidence of falls.

Time Frame: 1 year

The effectiveness will be measured in terms of less incidence of falls

Secondary Outcomes

  • To evaluate the cost-effectiveness of the 2 strategies proposed: conventional treatment vs early intervention.(1 year)

Study Sites (1)

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