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Incidence of Geriatric Syndromes Overlap

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ClinicalTrials.gov Identifier: NCT03647436
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Francisco Jose Tarazona-Santabalbina, Hospital de la Ribera

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.

Condition or disease Intervention/treatment
GERIATRIC SYNDROMES Hip Fractures GERIATRIC ASSESSMENT Delirium Depression Malnutrition Other: Comprehensive Geriatric Assessment. Both groups.

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 506 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Cohort Study on the Incidence of Geriatric Syndromes Overlap in Patients With Hospital Admission Due to Hip Fracture
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Evaluation of the incidence of geriatric syndromes: depression, delirium, cognitive disorders, falls, gait disturbances, urinary and fecal incontinence

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




Primary Outcome Measures :
  1. Depression and delirium overlap [ Time Frame: "4 weeks" ]

    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.



Secondary Outcome Measures :
  1. Hospital complications [ Time Frame: "4 weeks" ]

    To estimate :

    - Number of hospital complications (surgical wound infection, pneumonia, pressure sores, urinary tract infection, sepsis, Deep Venous Thrombosis, Pulmonary embolism)


  2. Hospital length of stay (days) [ Time Frame: "4 weeks" ]
    Measured in days

  3. Functional recovery. [ Time Frame: "4 weeks" ]

    Functional Ambulation Categories scale (FAC). Range 0 to 5. Positive functional recovery 2 or more points.

    Barthel Index for Activities of Daily Living. Range 0 to 100. <20 points: total dependence. 20-35 points: severe dependence. 40-55 points: moderate dependence.

    ≥ 60 points: mild dependence. 100 points: independence. The Lawton Instrumental Activities of Daily Living Scale. Range 0 to 8 Instrumental dependency 4 points or lower score


  4. Survival [ Time Frame: "1 year" ]
    To estimate the difference in in-hospital mortality and at 12 months between both groups.



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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-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. **).
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647436


Contacts
Contact: Francisco J Tarazona-Santabalbina, MD,PhD 0034962458100 ext 8387 fjtarazona@hospital-ribera.com
Contact: Maria Cuenca, PhD 0034962458100 ext 7462 macuenca@hospital-ribera.com

Locations
Spain
Hospital Universitario de la Ribera Recruiting
Alzira,, Kingdom Of Valéncia, Spain, 46660
Contact: Francisco J Tarazona-Santabalbina, MD,PhD    0034962458100 ext 8387    fjtarazona@hospital-ribera.com   
Contact: maria cuenca, PhD    962458100 ext 7462    macuenca@hospital-ribera.com   
Sponsors and Collaborators
Hospital de la Ribera
Investigators
Principal Investigator: Francisco J Tarazona-Santabalbina, MD, PhD Hospital Universitario de la Ribera

Publications:
Responsible Party: Francisco Jose Tarazona-Santabalbina, Principal Investigator, Hospital de la Ribera
ClinicalTrials.gov Identifier: NCT03647436     History of Changes
Other Study ID Numbers: HULRCP31072018
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Syndrome
Delirium
Malnutrition
Hip Fractures
Disease
Pathologic Processes
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Nutrition Disorders
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries