Clinical trial NCT03265691: Hyponatremia in the Prevention of Hospitalized Patients Falls
Official title: Effectiveness of Early Intervention in the Diagnosis and Treatment of Hyponatremia in the Prevention of Hospitalized Patients Falls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyponatremia
Accidental Falls
Keywords: Accidental Falls
Hyponatremia
Elderly
Risk factors
Nurse
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
Collaborators: name: Fundación Mutua Madrileña
First posted: 2017-08-29
Enrollment: 124
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: To evaluate the effectiveness of treatment of hyponatremia in reducing the incidence of falls.
timeFrame: 1 year
Secondary outcomes:
measure: To evaluate the cost-effectiveness of the 2 strategies proposed: conventional treatment vs early intervention.
timeFrame: 1 year
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
Study officials:
affiliation: carmen.lobo@salud.madrid.org
name: Carmen Lobo-Rodriguez, pHd
role: PRINCIPAL_INVESTIGATOR
References: