HyponatremiaPRECAHINCT03265691
Hyponatremia in the Prevention of Hospitalized Patients Falls
A study testing Early detection and treatment of hyponatremia in people with Hyponatremia and Accidental Falls, run by Mª del Carmen Lobo Rodríguez at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hyponatremia, Accidental Falls
- What is being tested?
- Early detection and treatment of hyponatremia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age >65 years
- Admitted to a participating study unit
- Wish to participate in the study and signature of informed consent.
Who cannot join
- Transfer of the patient to a unit not included in the study
- Deterioration of the patient's condition to severe or extremely painful
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Early Intervention in the Diagnosis and Treatment of 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.
Read the 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.
- Conditions
- Hyponatremia, Accidental Falls
- Being tested
- Early detection and treatment of hyponatremia, No Intervention (SOC)
- Keywords
- Accidental Falls, Hyponatremia, Elderly, Risk factors, Nurse
- Medical subject headings
- Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early detection and treatment of hyponatremiaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Early hyponatremia diagnosis and treatment | Experimental | The early diagnosis of hiponatremia is not a stándar procedure. In the experimental arm, hyponatremia will be diagnosed and treated early. Receives: Other: Early detection and treatment of hyponatremia; Other: No Intervention (SOC) |
| No intervention | No intervention | Usual pattern of work will be performed in all patients who enter in Hospital. Duration: 6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (1)
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study startDec 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyponatremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mª del Carmen Lobo Rodríguez
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Mutua Madrileña
- Responsible party
- Sponsor-investigator, Mª del Carmen Lobo Rodríguez, Hospital General Universitario Gregorio Marañon
- Investigators
- Carmen Lobo-Rodriguez, pHd, Principal investigator, carmen.lobo@salud.madrid.org
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265691
- Sponsor's protocol ID
- V01_Enf
- Acronym
- PRECAHI
- Status last verified
- Aug 2017
- First submitted
- 10 May 2016
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Early Intervention in the Diagnosis and Treatment of Hyponatremia in the Prevention of Hospitalized Patients Falls
- ClinicalTrials.gov ID
- NCT03265691
- Acronym / sponsor ID
- PRECAHI / V01_Enf
- Conditions
- Hyponatremia, Accidental Falls
- Keywords
- Accidental Falls, Hyponatremia, Elderly, Risk factors, Nurse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Mª del Carmen Lobo RodríguezUniversity, hospital or other
- Collaborators
- Fundación Mutua Madrileña
- Study start
- Dec 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 29 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early hyponatremia diagnosis and treatment | Experimental | Other: Early detection and treatment of hyponatremia, Other: No Intervention (SOC)The early diagnosis of hiponatremia is not a stándar procedure. In the experimental arm, hyponatremia will be diagnosed and treated early. |
| No intervention | No intervention | –Usual pattern of work will be performed in all patients who enter in Hospital. Duration: 6 months. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age >65 years
- Admitted to a participating study unit
- Wish to participate in the study and signature of informed consent.
Key exclusion criteria (2 listed)
- Transfer of the patient to a unit not included in the study
- Deterioration of the patient's condition to severe or extremely painful
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early detection and treatment of hyponatremiaIn 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. | Other | Early hyponatremia diagnosis and treatment |
| No Intervention (SOC)Usual pattern of work will be performed in all patients who enter in Hospital. | Other | Early hyponatremia diagnosis and treatment |
Primary outcome
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
1 secondary outcome
To evaluate the cost-effectiveness of the 2 strategies proposed: conventional treatment vs early intervention.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen Lobo-Rodriguez, pHd principal investigator
carmen.lobo@salud.madrid.org
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early detection and treatment of hyponatremia in people with Hyponatremia and Accidental Falls, run by Mª del Carmen Lobo Rodríguez at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effectiveness of treatment of hyponatremia in reducing the incidence of falls. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2017.