Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03265691
Other study ID # V01_Enf
Secondary ID
Status Completed
Phase N/A
First received May 10, 2016
Last updated August 28, 2017
Start date December 2014
Est. completion date December 2016

Study information

Verified date August 2017
Source Hospital General Universitario Gregorio Marañon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 124
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Early detection and treatment of hyponatremia
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)
Usual pattern of work will be performed in all patients who enter in Hospital.

Locations

Country Name City State
Spain Hospital General Universitario Gregorio Marañón Madrid

Sponsors (2)

Lead Sponsor Collaborator
Mª del Carmen Lobo Rodríguez Fundación Mutua Madrileña

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT05880862 - Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls Early Phase 1
Completed NCT03963570 - The Effectiveness of a Self-managed Digital Exercise Programme to Prevent Falls in Older Community-dwelling People N/A
Recruiting NCT04053829 - Feasibility and Acceptability of HOLOBalance Compared to Standard Care in Older Adults at Risk for Falls N/A
Not yet recruiting NCT04419753 - The Role of Attention Focus Walking Training in Older Adults. N/A
Completed NCT02916849 - A Feasibility Study of a Mobile Application Intervention to Promote Strength and Balance Exercises in Older People N/A
Completed NCT02836587 - The Influence of Balance Training on Postural Control in Elderly N/A
Active, not recruiting NCT02617303 - Prevention of Falls and Its Consequences in Elderly People N/A
Completed NCT01896466 - Enhanced Gait and Balance Training N/A
Completed NCT02570178 - Effectiveness of an Intervention to Improve Balance and Decrease Falls in the Elderly (EWii) N/A
Completed NCT00636675 - CONNECT for Quality: A Study to Reduce Falls in Nursing Homes N/A
Completed NCT00365430 - SAFE or SORRY? Patient Safety Study of the Prevention of Adverse Patient Outcomes N/A
Completed NCT00226486 - Examination and Treatment of Elderly After a Fall N/A
Active, not recruiting NCT00222287 - The Effect of Feldenkrais Lessons on Walking and Balance Phase 1
Recruiting NCT03731572 - Hip Muscle Power, Lateral Balance Function, and Falls in Aging N/A
Recruiting NCT05625828 - Evaluation of the Effects of a Cognitive-Motor Fall Prevention Program on Fall Risk Factors N/A
Recruiting NCT05377801 - Chinese Version of LIVE-LiFE for Older Adults With Previous Falls N/A
Completed NCT01618786 - Flooring for Injury Prevention Trial N/A
Completed NCT02835989 - Community Paramedicine at Home N/A
Recruiting NCT02926105 - Comparison of Home-based Exercise Programmes for Falls Prevention and Quality of Life in Older Adults Phase 3
Completed NCT02569138 - Balance-Enhancing Effects of Insole Hardness and Thickness for Older Adult Footwear N/A