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GERIATRIC SYNDROMESNCT03647436

Incidence of Geriatric Syndromes Overlap

An observational study of GERIATRIC SYNDROMES and Hip Fractures, run by Hospital de la Ribera at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 70 years and older
What is being tested?
Comprehensive Geriatric Assessment. Both groups.
How many people
506 participants
Where
1 siteSpain
Study dates
1 Aug 2018to 31 Dec 2019
Phase
Observational
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 70 years and older
  • All sexes
  • Older adult

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. **).

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Francisco J Tarazona-Santabalbina, MD,PhD contact

0034962458100 ext. 8387

fjtarazona@hospital-ribera.com

Spain1 site, 1 recruiting
  • Hospital Universitario de la Ribera

    Alzira, Kingdom of Valéncia, 46660

    Francisco J Tarazona-Santabalbina, MD,PhD, 0034962458100 ext. 8387, fjtarazona@hospital-ribera.com

    maria cuenca, PhD, 962458100 ext. 7462, macuenca@hospital-ribera.com

    Recruiting

Other trials in Spain

About this study

Official title: Prospective Cohort Study on the Incidence of Geriatric Syndromes Overlap in Patients With Hospital Admission Due to Hip Fracture

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.

Read the detailed description

The hypothesis of this work is that in patients with malnutrition, the incidence of overlap between delirium and depression is higher and causes worse health outcomes during hospital admission due to hip fracture. In addition, an increase in the incidence of other geriatricBoth groups. syndromes could be observed, increasing the severity of the known overlap.

Methods:

Objectives:

Main outcome: To evaluate the increase in the incidence of overlap between delirium and depression in patients with malnutrition with respect to patients without malnutrition and to check their influence on quality of care management indicators in patients admitted for hip fracture.

Secondary outcomes:

To estimate the difference in in-hospital mortality and at 12 months between both groups.

To estimate the influence of the joint incidence of the three geriatric syndromes on:

  • Number of hospital complications.
  • Hospital stay
  • Functional recovery.

Type of study:

A cohort study has been designed. Study period: August 2018- December 2019. Scope: Patients aged ≥70 years admitted to the University Hospital of La Ribera (HULR) with the main diagnosis of hip fracture (ICD 9 820.**).

Eligibility 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.**) undergoing surgery.

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.

Sample size:

Considering a hospital mortality of 11% in patients with delirium, compared to 4% obtained in the total of patients hospitalized for hip fracture in the period 2012-2016 in the HULR with an alpha error of 5% and a beta error of 15 % the sample size is 253 patients per group. The power of the study is 98.5%.

Study variables:

Age Gender Birthdate Date of admission Date of intervention Charlson Index Barthel scale for basic activities of daily life (Prior to admission, admission and discharge) Yesavage Depression Scale (15 items) Short-MiniNutritional Assessment (MNA) Scale Confusion Assessment Method (CAM) delirium Delirium Rating Scale-Revised-98 (DRS-R-98) scale of delirium intensity. Functional Ambulation Categories (FAC) walking scale Hospital mortality 365-day mortality Analytical parameters: Total cholesterol mg / dl Total protein g / dl Albumin g / dl Lymphocytes 109mm3 Calcidiol ng / ml Parathormone (PTH) μg / ml

Follow-up Survival and ambulatory capacity will be monitored 365 days after hospital discharge through access to the electronic medical record.

Statistic analysis The data will be analyzed with the statistical software program Statistical Package for the Social Sciences (SPSS) version 22 (SPSS Inc., Chicago, IL).

A description of the qualitative variables (including dichotomous) will be made by using absolute and relative frequencies. For the quantitative variables, measures of central tendency (mean and median), measures of position (median and quartiles next to box and whisker diagram), dispersion measures (range, interquartile range, variance and standard deviation) and measures of kurtosis will be used. and asymmetry.

The baseline differences between the groups will be analyzed by pruebas2 tests for categorical variables, using Fisher's exact test when any of the expected frequencies does not reach 5 units.

For the variables of quantitative type, with normality verified by the Kolmogorov-Smirnov test, to compare means between the different groups, we will use the T test for independent samples, in the dichotomous variables, and by means of ANOVA of a factor, in the variables with three or more categories. Non-parametric tests will be used: Mann-Whitney U, for dichotomous variables and Kruskal-Wallis for variables with three or more categories otherwise. Multiple comparisons between groups were analyzed using the Bonferroni test in the case of homoscedasticity and by the Games-Howell test in the case of heteroskedasticity, analyzed by the Levene's test.

For the analysis of the main objective, a survival analysis will be carried out using the Kaplan-Meier technique. Likewise, the Hazard Ratio of the mortality risk will be calculated by means of a Cox regression, using as confusing variables those considered as such in the analysis of the functioning of the randomization and those that, in the opinion of the investigators, present relevant clinical importance.

Finally, the calculation of the relative risks (RR) will be carried out together with its confidence interval at 95% of the incidence of hospitalizations and the ability to wander. A survival analysis will be performed using the Kaplan-Meier technique for each variable related to the secondary objectives. A Cox regression will be performed for each variable of the secondary objectives, using as confusing variables those considered as such in the analysis of the functioning of the randomization and those that, in the opinion of the researchers, present relevant clinical importance.

Limitations Those derived from a non-randomized study. To avoid interobserver variability, a trainer will be made with the personnel in charge of administering the scales together with a brief pilot study in which the agreement will be analyzed using the Kappa statistical test.

Being tested
Comprehensive Geriatric Assessment. Both groups.
Medical subject headings
Hip Fractures, Delirium, Depression, Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Comprehensive Geriatric Assessment. Both groups.Other

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

Study groups in NCT03647436
Study groupRoleWhat they receive
Exposed groupElderly 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.
Receives: Other: Comprehensive Geriatric Assessment. Both groups.
Control groupElderly 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.
Receives: Other: Comprehensive Geriatric Assessment. Both groups.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: "4 weeks"

Secondary outcomes (4)
  1. Hospital complications

    To estimate :

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

    Measured: "4 weeks"

  2. Hospital length of stay (days)

    Measured in days

    Measured: "4 weeks"

  3. Functional recovery.

    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

    Measured: "4 weeks"

  4. Survival

    To estimate the difference in in-hospital mortality and at 12 months between both groups.

    Measured: "1 year"

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2018
  2. Study start1 Aug 2018
  3. Primary completion31 Aug 2019 (estimated)
  4. Study completion31 Dec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
506 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03647436
Sponsor's protocol ID
HULRCP31072018
Status last verified
Aug 2018
First submitted
21 Aug 2018
Last updated
28 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 23636988
  • 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.

    PubMed 25243678

Questions about this trial

What is this clinical trial studying?

An observational study of GERIATRIC SYNDROMES and Hip Fractures, run by Hospital de la Ribera 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Aug 2018. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Francisco J Tarazona-Santabalbina, MD,PhD (0034962458100 ext. 8387, fjtarazona@hospital-ribera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depression and delirium overlap (time frame: "4 weeks"). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03647436, which also lists 2 linked publications.

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 28 Aug 2018.

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