FrailtyFRAILCOG-GENCT06700291
Preoperative Frailty and Postoperative Neurocognitive Disorders in Geriatric Patients in Georgia
An observational study of Frailty, run by New Hospitals Georgia at 1 site in Georgia.
Trial summary
The number of elderly people in the global population is growing, presenting an increasing challenge. Technological advances in medicine have made it possible to perform complex surgeries on geriatric patients, improving the viability of this age group. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty
- What is being tested?
- Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 230 participants
- Where
- 1 siteGeorgia
- Study dates
- 26 Apr 2023to 9 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Male or female patients aged 65y or more, scheduled for elective orthopedic surgery with knee or hip endoprosthesis.
Who may be able to join
- Male or female patients aged 65 years or older
- Scheduled for elective orthopedic surgery (hip or knee arthroplasty with endoprosthesis)
- Able to provide informed consent
Who cannot join
- Diagnosis of dementia (any type)
- Major psychiatric disorder (e.g., schizophrenia, bipolar disorder, severe depression)
- Surgery performed within the past 6 months
- Inability to complete neuropsychological assessment due to sensory or communication impairment (e.g., severe vision loss, hearing impairment, language barrier, aphasia)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Georgia1 site, 1 recruiting
- Recruiting
New Hospitals
Tbilisi, 0162
Tamar Macharadze, Dr, 004917665798734, tamar.macharadze@dtmu.edu.ge
About this study
The number of elderly people in the global population is growing, presenting an increasing challenge. Technological advances in medicine have made it possible to perform complex surgeries on geriatric patients, improving the viability of this age group. However, postoperative neurocognitive disorders represent the most common postoperative complications in this demographic, leading to increased morbidity and mortality, a reduced quality of life, and a heightened risk of dementia.
In high-income countries, studies have shown that preoperative frailty is associated with a cascade of postoperative disorders, including cognitive decline, delirium, dementia, and mortality. These complications negatively impact the community as a whole, healthcare staff and services, and the daily lives of those affected and their families. Perioperative neurocognitive disorders are linked to longer hospital stays, increased economic costs, reduced ability to work, and adverse consequences for family members and caregivers.
Read more
Frailty is a syndrome characterized by decreased reserve and resistance to stressors, resulting from cumulative declines in multiple physiological systems over time. This leaves individuals less capable of mounting a satisfactory response to stressful events. Frailty is most prevalent in the aging population, with its prevalence increasing exponentially with age.
This study will be the first to investigate preoperative frailty and its association with postoperative cognitive disorders in Georgia. Currently, there is limited information regarding the geriatric population in Georgia. The study will explore the prevalence of preoperative frailty and its impact on postoperative outcomes, including depression, dementia, cognitive dysfunction, delirium, and mortality at 30 days, three months, and one year following anesthesia and surgery.
This pioneering research will provide valuable insights into these disorders in low- and middle-income countries. It will fill a significant gap in the international literature by contributing essential knowledge that is currently lacking in this field.
Read the detailed description
Investigators will conduct a prospective, observational cohort study to determine the prevalence of frailty in the geriatric population of Georgia, focusing on men and women aged 65 years and older undergoing elective orthopedic surgery. All participants will provide written, informed consent to participate in the study.
Frailty will be assessed using the frail scale test preoperatively, at discharge, three months, and one year postoperatively. Baseline cognitive function will be evaluated using the Montreal Cognitive Assessment (MoCA) and modified Telephone Interview for Cognitive Status (TICSm) test and will enable cognitive screening and the detection of pre-existing cognitive disorders. Postoperative neurocognitive disorders (NCDs) will also be assessed with TICSm at one months, three months, and one year postoperatively through telephone follow-ups.
Delirium will be evaluated preoperatively and twice daily during the patient's hospital stay using the Three-Minute Diagnostic Interview for Confusion Assessment (3D-CAM). If patients require intensive care postoperatively, the Confusion Assessment Method for the ICU (ICU CAM) will also be administered twice daily.
Depression will be measured with the Geriatric Depression Scale (GDS) preoperatively and postoperatively at discharge, and again at one month, three months, and one year. Anxiety will be assessed using a visual analogue scale at baseline, discharge, one month, three months, and one year. The Trail Making Test A and B will be administered preoperatively and at discharge. Pain levels will be measured during each assessment using the Numerical Rating Scale (NRS).
Disability and the ability to perform daily living activities will be evaluated at baseline, three months, and one year postoperatively using the WHO Disability Assessment Schedule (WHODAS.2.0) and Activities of Daily Living -Prevention Instrument test (ADL-PI).
Additionally, investigators will collect demographic and clinical information, including education level, comorbidities, alcohol use, lifestyle factors, and body mass index (BMI). Laboratory tests will also be conducted to explore potential mechanisms underlying postoperative neurocognitive disorders (PND), such as albumin, HbA1c, triglycerides, electrolytes, creatinine, Vitamin D, and interleukin-6 (IL-6).
All assessments and tests originally in English will be translated into Georgian and validated for the Georgian population before being administered to patients in the hospital.
- Conditions
- Frailty
- Being tested
- Surgery
- Keywords
- Delirium,, Perioperative neurocognitive disorder, Geriatric anaesthesia, Dementia, Frailty
- Medical subject headings
- Frailty, Delirium, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Patient undergoing Anesthesia and Surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the prevalence of preoperative frailty
Frailty will be assessed using the FRAIL scale in patients aged 65 years and older undergoing planned orthopedic surgery and will be conducted at four time points: preoperatively, on the day of discharge, and at 3 and 12 months postoperatively.
Measured: Frailty assessments will be conducted at baseline preoperatively, on the day of hospital discharge (dependes how many days the patient stay in the hospital), and during follow-up at 3 months and 12 months post-surgery.
Secondary outcomes (9)
Correlation between preoperative frailty and postoperative disorders (postoperative delirium, delayed neurocognitive recovery and postoperative neurocognitive disorder) up to one year after surgery .
Frailty will be assessed using the FRAIL scale in patients aged 65 year and older undergoing planned orthopedic surgery. Postoperative delirium,delayed neurocognitive recovery and postoperative neurocognitive disorders will be assessed by following tests: 3D CAM, ICU CAM, Trial Making test A and B, TICSm.
Measured: Frailty: preop, within 12h prior to hospital discharge, and 3 & 12 mo postop; TMT A/B: baseline, within 12h prior to discharge; TICSm: 1, 3 & 12 mo postop; 3D-CAM & ICU-CAM: twice daily from postop day 1 until within 12 hours prior to discharge.
Preoperative demographics and risk factors, including but not limited to age, level of education, and comorbidities, and their correlation with any perioperative neurocognitive disorders up to twelve months following surgery.
Preoperative demographic information and risk factors-including, but not limited to, age, education, and comorbidities-will be collected. Upon study completion, these factors will be analyzed for their correlation with postoperative outcomes
Measured: Demographic information and risk factors will be collected on baseline.Postopereative outcomes will be collected on the day of discharge from the hospital,1 months, 3 months and 1 year after the surgery.
Prevalence of preoperative cognitive impairment
Preoperative cognitive impairment will be assessed using both the Montreal Cognitive Assessment (MoCA) and the modified Telephone Interview for Cognitive Status (TICSm).
Measured: MoCA and TICSm - preoperative;
Correlation between preoperative cognitive impairment and postoperative disorders (postoperative delirium, delayed neurocognitive recovery and postoperative neurocognitive disorder) up to one year after surgery
Preoperative cognitive impairment will be assessed using both the Montreal Cognitive Assessment (MoCA) and the modified Telephone Interview for Cognitive Status (TICSm). Postoperative delirium,delayed neurocognitive recovery and postoperative neurocognitive disorders will be assessed by following tests: 3D CAM, ICU CAM, Trial Making test A and B, TICSm.
Measured: MoCA and TICSm - preop; TICSm-1,3 and 12 mo postop. 3D-CAM: twice daily from postop day 1 until within 12h prior to hospital discharge; ICU-CAM: twice daily while in ICU; TMT A/B: preop baseline and within 12h prior to discharge regardless of stay length
Determine the prevalence of depression in older adults presenting for anesthesia and surgery.
Depression will be assessed using the Geriatric Depression Scale (GDS) preoperatively.
Measured: Assessment time points: preoperative baseline
Preoperative depression in older adults in Georgia presenting for anesthesia and surgery correlation with postoperative depression during different time points
Depression will be essessed with geriatric depression scale teset preoperatively, on the day of discharge , one months and three months postop and one year after surgery.
Measured: Baseline, on the day of discharge, one months and three months postop,one year after the surgery
To determine the mortality rate up to one year after anesthesia and surgery
Mortality will be recorded through hospital records and follow-up telephone contact with the a family member at one months, three months and twelve months after surgery.
Measured: In hospital,1 months, 3 months and 12 months postoperatively.
Patient disability change among older adults in Georgia from the preoperative to postoperative period using WHO Disability Assessment Schedule 2.0
Disability will be assessed using the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) questionaries. They will be administered peroperatively, 3 months and 12 months postoperatively. Acording the scores these assessments will help to evaluate changes in functional status over time.Allowing anylysis of the impact of surgery and anesthesia on patients disability .
Measured: WHODAS 2. questionary will be used Preoperatively, 3 months and 12 months postoperatively.
Patient quality of life change among older adults in Georgia from the preoperative to postoperative period using Daily Living prevention instrument questionary.
Patient quality of life will be assessed using the Daily Living prevention instrument questionaries. They will be administered peroperatively, 3 months and 12 months postoperatively. According the scores these assessments will help to evaluate changes in daily living over time.Allowing anylysis of the impact of surgery and anesthesia on patients functional ability .
Measured: Daily Living prevention instrument questionaries will be used Preoperatively, 3 months and 12 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start26 Apr 2023
- Primary completion9 Apr 2026 (estimated)
- Study completion9 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies 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
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New Hospitals Georgia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamar Macharadze, New Hospitals Georgia
- Investigators
- Tamar Macharadze, Dr, Principal investigator, David Tvildiani Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700291
- Sponsor's protocol ID
- 01/01
- Acronym
- FRAILCOG-GE
- Status last verified
- Nov 2024
- First submitted
- 1 Nov 2024
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Darsalia T, Evered L, Macharadze T. Preoperative frailty and postoperative neurocognitive disorders in older adults in Georgia: study protocol for a prospective, observational cohort study. BMJ Open. 2025 Oct 20;15(10):e101245. doi: 10.1136/bmjopen-2025-101245.
PubMed 41120173
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Frailty and Postoperative Neurocognitive Disorders in Geriatric Patients in Georgia
- ClinicalTrials.gov ID
- NCT06700291
- Acronym / sponsor ID
- FRAILCOG-GE / 01/01
- Conditions
- Frailty
- Keywords
- Delirium,, Perioperative neurocognitive disorder, Geriatric anaesthesia, Dementia, Frailty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- New Hospitals GeorgiaUniversity, hospital or other
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 9 Apr 2026 (estimated)
- Study completion
- 9 Apr 2026 (estimated)
- First posted
- 21 Nov 2024 (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 number of elderly people in the global population is growing, presenting an increasing challenge. Technological advances in medicine have made it possible to perform complex surgeries on geriatric patients, improving the viability of this age group. However, postoperative neurocognitive disorders represent the most common postoperative complications in this demographic, leading to increased morbidity and mortality, a reduced quality of life, and a heightened risk of dementia.
In high-income countries, studies have shown that preoperative frailty is associated with a cascade of postoperative disorders, including cognitive decline, delirium, dementia, and mortality. These complications negatively impact the community as a whole, healthcare staff and services, and the daily lives of those affected and their families. Perioperative neurocognitive disorders are linked to longer hospital stays, increased economic costs, reduced ability to work, and adverse consequences for family members and caregivers.
Frailty is a syndrome characterized by decreased reserve and resistance to stressors, resulting from cumulative declines in multiple physiological systems over time. This leaves individuals less capable of mounting a satisfactory response to stressful events. Frailty is most prevalent in the aging population, with its prevalence increasing exponentially with age.
This study will be the first to investigate preoperative frailty and its association with postoperative cognitive disorders in Georgia. Currently, there is limited information regarding the geriatric population in Georgia. The study will explore the prevalence of preoperative frailty and its impact on postoperative outcomes, including depression, dementia, cognitive dysfunction, delirium, and mortality at 30 days, three months, and one year following anesthesia and surgery.
This pioneering research will provide valuable insights into these disorders in low- and middle-income countries. It will fill a significant gap in the international literature by contributing essential knowledge that is currently lacking in this field.
Detailed description
Investigators will conduct a prospective, observational cohort study to determine the prevalence of frailty in the geriatric population of Georgia, focusing on men and women aged 65 years and older undergoing elective orthopedic surgery. All participants will provide written, informed consent to participate in the study.
Frailty will be assessed using the frail scale test preoperatively, at discharge, three months, and one year postoperatively. Baseline cognitive function will be evaluated using the Montreal Cognitive Assessment (MoCA) and modified Telephone Interview for Cognitive Status (TICSm) test and will enable cognitive screening and the detection of pre-existing cognitive disorders. Postoperative neurocognitive disorders (NCDs) will also be assessed with TICSm at one months, three months, and one year postoperatively through telephone follow-ups.
Delirium will be evaluated preoperatively and twice daily during the patient's hospital stay using the Three-Minute Diagnostic Interview for Confusion Assessment (3D-CAM). If patients require intensive care postoperatively, the Confusion Assessment Method for the ICU (ICU CAM) will also be administered twice daily.
Depression will be measured with the Geriatric Depression Scale (GDS) preoperatively and postoperatively at discharge, and again at one month, three months, and one year. Anxiety will be assessed using a visual analogue scale at baseline, discharge, one month, three months, and one year. The Trail Making Test A and B will be administered preoperatively and at discharge. Pain levels will be measured during each assessment using the Numerical Rating Scale (NRS).
Disability and the ability to perform daily living activities will be evaluated at baseline, three months, and one year postoperatively using the WHO Disability Assessment Schedule (WHODAS.2.0) and Activities of Daily Living -Prevention Instrument test (ADL-PI).
Additionally, investigators will collect demographic and clinical information, including education level, comorbidities, alcohol use, lifestyle factors, and body mass index (BMI). Laboratory tests will also be conducted to explore potential mechanisms underlying postoperative neurocognitive disorders (PND), such as albumin, HbA1c, triglycerides, electrolytes, creatinine, Vitamin D, and interleukin-6 (IL-6).
All assessments and tests originally in English will be translated into Georgian and validated for the Georgian population before being administered to patients in the hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Male or female patients aged 65y or more, scheduled for elective orthopedic surgery with knee or hip endoprosthesis.
Key inclusion criteria (3 listed)
- Male or female patients aged 65 years or older
- Scheduled for elective orthopedic surgery (hip or knee arthroplasty with endoprosthesis)
- Able to provide informed consent
Key exclusion criteria (4 listed)
- Diagnosis of dementia (any type)
- Major psychiatric disorder (e.g., schizophrenia, bipolar disorder, severe depression)
- Surgery performed within the past 6 months
- Inability to complete neuropsychological assessment due to sensory or communication impairment (e.g., severe vision loss, hearing impairment, language barrier, aphasia)
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 |
|---|---|---|
| SurgeryPatient undergoing Anesthesia and Surgery | Procedure or surgery | – |
Primary outcome
Determine the prevalence of preoperative frailty
Time frame: Frailty assessments will be conducted at baseline preoperatively, on the day of hospital discharge (dependes how many days the patient stay in the hospital), and during follow-up at 3 months and 12 months post-surgery.
Frailty will be assessed using the FRAIL scale in patients aged 65 years and older undergoing planned orthopedic surgery and will be conducted at four time points: preoperatively, on the day of discharge, and at 3 and 12 months postoperatively.
9 secondary outcomes
Correlation between preoperative frailty and postoperative disorders (postoperative delirium, delayed neurocognitive recovery and postoperative neurocognitive disorder) up to one year after surgery .
Time frame: Frailty: preop, within 12h prior to hospital discharge, and 3 & 12 mo postop; TMT A/B: baseline, within 12h prior to discharge; TICSm: 1, 3 & 12 mo postop; 3D-CAM & ICU-CAM: twice daily from postop day 1 until within 12 hours prior to discharge.
Preoperative demographics and risk factors, including but not limited to age, level of education, and comorbidities, and their correlation with any perioperative neurocognitive disorders up to twelve months following surgery.
Time frame: Demographic information and risk factors will be collected on baseline.Postopereative outcomes will be collected on the day of discharge from the hospital,1 months, 3 months and 1 year after the surgery.
Prevalence of preoperative cognitive impairment
Time frame: MoCA and TICSm - preoperative;
Correlation between preoperative cognitive impairment and postoperative disorders (postoperative delirium, delayed neurocognitive recovery and postoperative neurocognitive disorder) up to one year after surgery
Time frame: MoCA and TICSm - preop; TICSm-1,3 and 12 mo postop. 3D-CAM: twice daily from postop day 1 until within 12h prior to hospital discharge; ICU-CAM: twice daily while in ICU; TMT A/B: preop baseline and within 12h prior to discharge regardless of stay length
Determine the prevalence of depression in older adults presenting for anesthesia and surgery.
Time frame: Assessment time points: preoperative baseline
Preoperative depression in older adults in Georgia presenting for anesthesia and surgery correlation with postoperative depression during different time points
Time frame: Baseline, on the day of discharge, one months and three months postop,one year after the surgery
To determine the mortality rate up to one year after anesthesia and surgery
Time frame: In hospital,1 months, 3 months and 12 months postoperatively.
Patient disability change among older adults in Georgia from the preoperative to postoperative period using WHO Disability Assessment Schedule 2.0
Time frame: WHODAS 2. questionary will be used Preoperatively, 3 months and 12 months postoperatively.
Patient quality of life change among older adults in Georgia from the preoperative to postoperative period using Daily Living prevention instrument questionary.
Time frame: Daily Living prevention instrument questionaries will be used Preoperatively, 3 months and 12 months postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Derived from this study: PubMed 41120173Darsalia T, Evered L, Macharadze T. Preoperative frailty and postoperative neurocognitive disorders in older adults in Georgia: study protocol for a prospective, observational cohort study. BMJ Open. 2025 Oct 20;15(10):e101245. doi: 10.1136/bmjopen-2025-101245.
- Individual participant dataSharing planned: Undecided
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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.
Tamar Macharadze, Dr principal investigator
David Tvildiani Medical University
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 Frailty, run by New Hospitals Georgia at 1 site in Georgia.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 29 Aug 2025. 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 Georgia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tamar Macharadze, Dr (004917665798734, tamar.macharadze@dtmu.edu.ge), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the prevalence of preoperative frailty (time frame: Frailty assessments will be conducted at baseline preoperatively, on the day of hospital discharge (dependes how many days the patient stay in the hospital), and during follow-up at 3 months and 12 months post-surgery.). 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 NCT06700291, which also lists 1 linked publication.
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 29 Aug 2025.