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.
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
- Conditions the study is for
- GERIATRIC SYNDROMES, Hip Fractures, GERIATRIC ASSESSMENT
- 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
Spain1 site, 1 recruiting
- 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
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.
- Conditions
- GERIATRIC SYNDROMES, Hip Fractures, GERIATRIC ASSESSMENT, Delirium, Depression, Malnutrition
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Comprehensive Geriatric Assessment. Both groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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"
Hospital length of stay (days)
Measured in days
Measured: "4 weeks"
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"
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.
- First posted27 Aug 2018
- Study start1 Aug 2018
- Primary completion31 Aug 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GERIATRIC SYNDROMESStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hospital de la Ribera
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Jose Tarazona-Santabalbina, Hospital de la Ribera
- Investigators
- Francisco J Tarazona-Santabalbina, MD, PhD, Principal investigator, Hospital Universitario de la Ribera
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 23636988Radinovic 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study on the Incidence of Geriatric Syndromes Overlap in Patients With Hospital Admission Due to Hip Fracture
- ClinicalTrials.gov ID
- NCT03647436
- Acronym / sponsor ID
- HULRCP31072018
- Conditions
- GERIATRIC SYNDROMES, Hip Fractures, GERIATRIC ASSESSMENT, Delirium, Depression, Malnutrition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 506 participants (estimated)
- Lead sponsor
- Hospital de la RiberaUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 27 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed group | – | Other: Comprehensive Geriatric Assessment. Both groups.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. |
| Control group | – | Other: Comprehensive Geriatric Assessment. Both groups.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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Age groups
- 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. **).
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Life expectancy less than 3 months Dementia GDS 7 that prevents collaboration in the completion of the scale of Global Depression of Yesavage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive Geriatric Assessment. Both groups.Evaluation of the incidence of geriatric syndromes: depression, delirium, cognitive disorders, falls, gait disturbances, urinary and fecal incontinence | Other | Control group, Exposed group |
Primary outcome
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.
4 secondary outcomes
Hospital complications
Time frame: "4 weeks"
Hospital length of stay (days)
Time frame: "4 weeks"
Functional recovery.
Time frame: "4 weeks"
Survival
Time frame: "1 year"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Background: PubMed 23636988Downing 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.
- Background: PubMed 25243678Radinovic 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.
- Individual participant dataSharing planned: Undecided
Related trials for GERIATRIC SYNDROMES
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Recruiting
Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults
Frailty Syndrome, Prefrail Elderly
Enrolling by invitation
Promoting Aging and Thriving With HIV
HIV (Human Immunodeficiency Virus), Geriatric
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco J Tarazona-Santabalbina, MD,PhD contact
Francisco J Tarazona-Santabalbina, MD, PhD principal investigator
Hospital Universitario de la Ribera
1 site in 1 country: see every site and its status.
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.