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Completed

NCT Number: NCT03265691

Hyponatremia in the Prevention of Hospitalized Patients Falls

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.

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Key information

Conditions

Hyponatremia Accidental Falls Metabolic Diseases Nutritional and Metabolic Diseases Water-Electrolyte Imbalance

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

About this study

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

Aims:

  • To assess the effectiveness of corrective activity of hyponatremia in falls reducing incidence.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early detection and treatment of hyponatremia

Other

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)

Other

Usual pattern of work will be performed in all patients who enter in Hospital.

Primary outcomes

  1. 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

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

    Time frame: 1 year

    The cost-effectiveness will be indirectly measured using Average cost per inpatient day

Sponsors and collaborators

Lead sponsor

Mª del Carmen Lobo Rodríguez

Other

Collaborators

  • Fundación Mutua Madrileña

Registry information

Official study title

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

Acronym: PRECAHI

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 29, 2017
Registry last updated
Aug 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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