Hyponatremia in the Prevention of Hospitalized Patients Falls (PRECAHI)
Primary Purpose
Hyponatremia, Accidental Falls
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Early detection and treatment of hyponatremia
No Intervention (SOC)
Sponsored by
About this trial
This is an interventional prevention trial for Hyponatremia focused on measuring Accidental Falls, Hyponatremia, Elderly, Risk factors, Nurse
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
Sites / Locations
- Hospital General Universitario Gregorio Marañón
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Early hyponatremia diagnosis and treatment
No intervention
Arm Description
The early diagnosis of hiponatremia is not a stándar procedure. In the experimental arm, hyponatremia will be diagnosed and treated early.
Usual pattern of work will be performed in all patients who enter in Hospital. Duration: 6 months.
Outcomes
Primary Outcome Measures
To evaluate the effectiveness of treatment of hyponatremia in reducing the incidence of falls.
The effectiveness will be measured in terms of less incidence of falls
Secondary Outcome Measures
To evaluate the cost-effectiveness of the 2 strategies proposed: conventional treatment vs early intervention.
The cost-effectiveness will be indirectly measured using Average cost per inpatient day
Full Information
NCT ID
NCT03265691
First Posted
May 10, 2016
Last Updated
August 28, 2017
Sponsor
Mª del Carmen Lobo Rodríguez
Collaborators
Fundación Mutua Madrileña
1. Study Identification
Unique Protocol Identification Number
NCT03265691
Brief Title
Hyponatremia in the Prevention of Hospitalized Patients Falls
Acronym
PRECAHI
Official Title
Effectiveness of Early Intervention in the Diagnosis and Treatment of Hyponatremia in the Prevention of Hospitalized Patients Falls
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mª del Carmen Lobo Rodríguez
Collaborators
Fundación Mutua Madrileña
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyponatremia, Accidental Falls
Keywords
Accidental Falls, Hyponatremia, Elderly, Risk factors, Nurse
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early hyponatremia diagnosis and treatment
Arm Type
Experimental
Arm Description
The early diagnosis of hiponatremia is not a stándar procedure. In the experimental arm, hyponatremia will be diagnosed and treated early.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Usual pattern of work will be performed in all patients who enter in Hospital. Duration: 6 months.
Intervention Type
Other
Intervention Name(s)
Early detection and treatment of hyponatremia
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No Intervention (SOC)
Intervention Description
Usual pattern of work will be performed in all patients who enter in Hospital.
Primary Outcome Measure Information:
Title
To evaluate the effectiveness of treatment of hyponatremia in reducing the incidence of falls.
Description
The effectiveness will be measured in terms of less incidence of falls
Time Frame
1 year
Secondary Outcome Measure Information:
Title
To evaluate the cost-effectiveness of the 2 strategies proposed: conventional treatment vs early intervention.
Description
The cost-effectiveness will be indirectly measured using Average cost per inpatient day
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Lobo-Rodriguez, pHd
Organizational Affiliation
carmen.lobo@salud.madrid.org
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
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Hyponatremia in the Prevention of Hospitalized Patients Falls
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