Depression Clinical Trial
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.
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.
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