NCT03647436

Brief Summary

The overlap of depression and delirium as geriatric syndromes present in elderly patients with hospital admission due to hip fracture has been previously studied. Nevertheless, the relationships between these two clinical processes and other geriatric syndromes, especially malnutrition, have not been studied. For this reason, a prospective cohort study has been designed to know the differences in the incidence of geriatric syndromes during hospital admission due to hip fracture in patients with and without risk of malnutrition.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
506

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 21, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 27, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

August 28, 2018

Status Verified

August 1, 2018

Enrollment Period

1.1 years

First QC Date

August 21, 2018

Last Update Submit

August 24, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Depression and delirium overlap

    To evaluate the incidence of overlap between delirium and depression in patients with malnutrition compared to patients without malnutrition Measures: Prevalence of depression in admitted patients using Geriatric Depression Scale (GDS) of Yesavage. 15-items version. Range 0 to 15 points. Depression is considered with 7 or more points. Incidence of depression in admitted patients using Confusion Assessment Method (CAM). Range 0 to 4 points. CAM is considered positive for delirium with 3 points.

    "4 weeks"

Secondary Outcomes (4)

  • Hospital complications

    "4 weeks"

  • Hospital length of stay (days)

    "4 weeks"

  • Functional recovery.

    "4 weeks"

  • Survival

    "1 year"

Study Arms (2)

Exposed group

Elderly patients with hospital admission due to hip fracture and score less than 12 points in the short-MNA at the moment of hospital admission. Intervention: Comprehensive Geriatric Assesment (CGA). Both groups. CGA includes measuring of: Previous functional assessment of daily life activities (Barthel and Lawton index), a cognitive screening (MiniMental State Examination), the turn-based assessment of the presence of delirium (Confusion Assessment Method) and in case of presence of delirium will be measured the duration and intensity of the symptoms (Delirium Rating Scale-Revised-98). Likewise, the presence of frailty (Clinical Frailty Scale) and walking ability (Functional Ambulation Categories) will be evaluated.

Other: Comprehensive Geriatric Assessment. Both groups.

Control group

Elderly patients with hospital admission due to hip fracture and score equal or higher than 12 points in the short MNA at the moment of hospital admission Intervention: Comprehensive Geriatric Assesment (CGA). Both groups. CGA includes measuring of: Previous functional assessment of daily life activities (Barthel and Lawton index), a cognitive screening (MiniMental State Examination), the turn-based assessment of the presence of delirium (Confusion Assessment Method) and in case of presence of delirium will be measured the duration and intensity of the symptoms (Delirium Rating Scale-Revised-98). Likewise, the presence of frailty (Clinical Frailty Scale) and walking ability (Functional Ambulation Categories) will be evaluated.

Other: Comprehensive Geriatric Assessment. Both groups.

Interventions

Evaluation of the incidence of geriatric syndromes: depression, delirium, cognitive disorders, falls, gait disturbances, urinary and fecal incontinence

Control groupExposed group

Eligibility Criteria

Age70 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged ≥70 years admitted to the University Hospital of La Ribera (HULR) with the main diagnosis of hip fracture (ICD 9 820. \*\*).

You may qualify if:

  • Patients ≥70 years admitted to the University Hospital of La Ribera (HULR) with the main diagnosis of hip fracture (ICD 9 820. \*\*) that are going to be operated on.

You may not qualify if:

  • Life expectancy less than 3 months Dementia GDS 7 that prevents collaboration in the completion of the scale of Global Depression of Yesavage.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario de la Ribera

Alzira, Kingdom of Valéncia, 46660, Spain

RECRUITING

Related Publications (2)

  • Downing LJ, Caprio TV, Lyness JM. Geriatric psychiatry review: differential diagnosis and treatment of the 3 D's - delirium, dementia, and depression. Curr Psychiatry Rep. 2013 Jun;15(6):365. doi: 10.1007/s11920-013-0365-4.

    PMID: 23636988BACKGROUND
  • Radinovic KS, Markovic-Denic L, Dubljanin-Raspopovic E, Marinkovic J, Jovanovic LB, Bumbasirevic V. Effect of the overlap syndrome of depressive symptoms and delirium on outcomes in elderly adults with hip fracture: a prospective cohort study. J Am Geriatr Soc. 2014 Sep;62(9):1640-8. doi: 10.1111/jgs.12992.

    PMID: 25243678BACKGROUND

MeSH Terms

Conditions

Hip FracturesDeliriumDepressionMalnutrition

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersBehavioral SymptomsBehaviorNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Francisco J Tarazona-Santabalbina, MD, PhD

    Hospital Universitario de la Ribera

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Francisco J Tarazona-Santabalbina, MD,PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 21, 2018

First Posted

August 27, 2018

Study Start

August 1, 2018

Primary Completion

August 31, 2019

Study Completion

December 31, 2019

Last Updated

August 28, 2018

Record last verified: 2018-08

Locations