Hyponatremia in the Prevention of Hospitalized Patients Falls
PRECAHI
Effectiveness of Early Intervention in the Diagnosis and Treatment of Hyponatremia in the Prevention of Hospitalized Patients Falls
1 other identifier
interventional
124
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedFirst Posted
Study publicly available on registry
August 29, 2017
CompletedAugust 29, 2017
August 1, 2017
2 years
May 10, 2016
August 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
1 year
Secondary Outcomes (1)
To evaluate the cost-effectiveness of the 2 strategies proposed: conventional treatment vs early intervention.
1 year
Study Arms (2)
Early hyponatremia diagnosis and treatment
EXPERIMENTALThe early diagnosis of hiponatremia is not a stándar procedure. In the experimental arm, hyponatremia will be diagnosed and treated early.
No intervention
NO INTERVENTIONUsual pattern of work will be performed in all patients who enter in Hospital. Duration: 6 months.
Interventions
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.
Usual pattern of work will be performed in all patients who enter in Hospital.
Eligibility Criteria
You may qualify if:
- Age \>65 years
- Admitted to a participating study unit
- Wish to participate in the study and signature of informed consent.
You may not qualify if:
- Transfer of the patient to a unit not included in the study
- Deterioration of the patient's condition to severe or extremely painful
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mª del Carmen Lobo Rodríguezlead
- Fundación Mutua Madrileñacollaborator
Study Sites (1)
Hospital General Universitario Gregorio Marañón
Madrid, 28007, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carmen Lobo-Rodriguez, pHd
carmen.lobo@salud.madrid.org
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Msc Nurse Research
Study Record Dates
First Submitted
May 10, 2016
First Posted
August 29, 2017
Study Start
December 1, 2014
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
August 29, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share