Frail Elderly SyndromeNCT04056871
Different Frailty Scores to Incidence of Post-operative Delirium and Cognitive Dysfunction
An observational study of Frail Elderly Syndrome and Postoperative Delirium, run by University of Malaya at 1 site in Malaysia.
Trial summary
Patients who are frail will have higher rate for post-operative morbidities, mortality, prolonged hospital stays, loss of independence, increase in institutionalization, post-operative cognitive dysfunction (POCD) and delirium (POD). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frail Elderly Syndrome, Postoperative Delirium, Postoperative Cognitive Dysfunction
- What is being tested?
- Frailty Screening Tools
- How many people
- 400 participants
- Where
- 1 siteMalaysia
- Study dates
- 20 Aug 2019to 20 Feb 2020
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: All patients above 65 years of age undergoing elective surgery under anesthetic care for both general and regional anesthesia with or without sedation.
Who may be able to join
- Age 65 years old and above
- ASA 1 - 3
- Full GCS
- Elective surgery
- Able to communicate well
- Consented
- Extubated at the end of surgery
Who cannot join
- Cardiac and neurosurgery
- On drugs affecting the central nervous system
- Admission to ICU intubated to continue ventilation.
- Refusal of consent
- Severe hearing loss
- Unable to use telephone/ mobile phone for communication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Association of Different Frailty Scores to the Incidence of Post-operative Delirium and Cognitive Dysfunction
Patients who are frail will have higher rate for post-operative morbidities, mortality, prolonged hospital stays, loss of independence, increase in institutionalization, post-operative cognitive dysfunction (POCD) and delirium (POD).
So, it is crucial to find a suitable frailty assessment tool that can be incorporated into a guideline and reference for our local setting in geriatric peri-operative management. In the mean time, create awareness regarding the frailty elderly population with POD, POCD and other associated poor outcomes among our clinicians.
Read the detailed description
Increasing life expectancy has led to increase in elderly populations, thus the elderly patients amounting for greater proportion of surgical cases. But, most of them are frail with multiple co-morbidities and are exposed to adverse outcome post-operatively. The commonest adverse outcomes is post-operative delirium (POD) in which clinicians often miss and often take lightly. If it is not treated, it will progress to post-operative cognitive dysfunction (POCD).
So, it is crucial to identify the risk factors pre-operatively to minimize the risk of POD and POCD. The frail patients are more likely to have pre-existing cognitive impairment with reduced cognitive reserve, hence, they are the most vulnerable to POCD and POD. One of the most commonly used frailty screening tools is Fried Frailty criteria which is an easily accessible tool that mainly screens and scores the patients physically. However, the investigators propose to use the Groningen Frailty scale as it can assess the patients in a more holistic approach, not only in physical, but also vision, heating, nutritional, co-morbidities, cognition, psychosocial and mobility of the patients.
Method:
Elderly patients >65 years old undergoing elective surgery under general or local anaesthesia in University Malaya Medical Centre will be recruited for this study, over a 6 months period from August 2019 to January 2020. Patients will be assessed with baseline cognitive assessment, nutritional status, psychological status, and frailty scores prior to the surgery. After the operation, patients will be assessed using 4AT and CAM for at least 5 days or until patients discharged. Cognitive functions will be assessed on post-operative 7th day, 1 month and 3 months with T-MOCA via phone.
All data will be analyzed using SPSS.
Impact of research:
A suitable frailty assessment tool will be identified to be used pre-operatively for elderly patients undergoing elective surgery. This tool will then be incorporated into a guideline and reference in our local setting for geriatric peri-operative management protocol.
Moreover, with the results, investigators hope to create awareness within our multidisciplinary care of elderly surgical population on frailty assessment and its correlation to post-operative delirium, cognitive dysfunction and associated poor outcomes.
- Being tested
- Frailty Screening Tools
- Keywords
- post-operative delirium, post-operative cognitive dysfunction, frailty, nutritional status, depression
- Medical subject headings
- Emergence Delirium, Postoperative Cognitive Complications, Frailty, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frailty Screening ToolsDiagnostic test
This is an observational and prospective study of patients who are going for elective surgery, thus no intervention will be given.
| Study group | Role | What they receive |
|---|---|---|
| Fried Frailty Phenotype | This group of patients will be assess by using 5 characteristics of Frailty which are weight loss, weakness, exhaustion, low activity and physical fitness of the patients. Patients classify as frail will have more than 3 criteria, intermediate or pre-frail will be 1 or 2 criteria present and robust will not have criteria. Receives: Diagnostic Test: Frailty Screening Tools | |
| Groningen Frailty Index | GFI is a simple questionnaire consisting of 15 items which are classified into 8 groups, consistent of 4 domains of functioning. A score of 4 or more indicates a higher risk for frailty and possible delirium. Receives: Diagnostic Test: Frailty Screening Tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of confusion using Confusion Assessment Method (CAM) scores
Delirium is present if the following are present:
Feature 1-Acute Change or/and Fluctuation (any symptom) AND Feature 2-Inattention AND EITHER Feature 3-Disorganized Thinking OR Feature 4-Altered Level of Consciousness
Measured: Within 5 days after surgery
Change in cognitive function using Telephone-Montreal Cognitive Assessment (T-MOCA)
Cognitive function of the patients will be assessed after discharged and must achieved post-operative day 7 with T-MOCA via phone, subsequently assessed at 1 month and 3 month later.
Measured: Within 1 month
Occurence of delirium using 4AT scores
A score of 4 or more suggests delirium but is not diagnostic: more detailed assessment of mental status may be required to reach a diagnosis. A score of 1-3 suggests cognitive impairment and more detailed cognitive testing and informant history-taking are required. A score of 0 does not definitively exclude delirium or cognitive impairment: more detailed testing may be required depending on the clinical context.
Measured: Within 5 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start20 Aug 2019
- Primary completion30 Jan 2020
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (53)Papers the sponsor has linked to this study.
- Other trials for Frail Elderly SyndromeStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- 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
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Loh Pui San, University of Malaya
- Investigators
- Pui San Loh, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056871
- Sponsor's protocol ID
- U1111-1237-9788
- Status last verified
- Apr 2020
- First submitted
- 8 Aug 2019
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.
PubMed 23395245Xue QL. The frailty syndrome: definition and natural history. Clin Geriatr Med. 2011 Feb;27(1):1-15. doi: 10.1016/j.cger.2010.08.009.
PubMed 21093718Peri-operative Care for Older Patients Undergoing Surgery. British Geriatrics Society. http://www.bgs.org.uk/index.php/topresources/publicationfind/goodpractice/2402-bpg-pops (cited November 2015
Makary MA, Segev DL, Pronovost PJ, Syin D, Bandeen-Roche K, Patel P, Takenaga R, Devgan L, Holzmueller CG, Tian J, Fried LP. Frailty as a predictor of surgical outcomes in older patients. J Am Coll Surg. 2010 Jun;210(6):901-8. doi: 10.1016/j.jamcollsurg.2010.01.028. Epub 2010 Apr 28.
PubMed 20510798Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
PubMed 11253156Collard RM, Boter H, Schoevers RA, Oude Voshaar RC. Prevalence of frailty in community-dwelling older persons: a systematic review. J Am Geriatr Soc. 2012 Aug;60(8):1487-92. doi: 10.1111/j.1532-5415.2012.04054.x. Epub 2012 Aug 6.
PubMed 22881367Fried LP, Xue QL, Cappola AR, Ferrucci L, Chaves P, Varadhan R, Guralnik JM, Leng SX, Semba RD, Walston JD, Blaum CS, Bandeen-Roche K. Nonlinear multisystem physiological dysregulation associated with frailty in older women: implications for etiology and treatment. J Gerontol A Biol Sci Med Sci. 2009 Oct;64(10):1049-57. doi: 10.1093/gerona/glp076. Epub 2009 Jun 30.
PubMed 19567825Sepehri A, Beggs T, Hassan A, Rigatto C, Shaw-Daigle C, Tangri N, Arora RC. The impact of frailty on outcomes after cardiac surgery: a systematic review. J Thorac Cardiovasc Surg. 2014 Dec;148(6):3110-7. doi: 10.1016/j.jtcvs.2014.07.087. Epub 2014 Aug 7.
PubMed 25199821Beggs T, Sepehri A, Szwajcer A, Tangri N, Arora RC. Frailty and perioperative outcomes: a narrative review. Can J Anaesth. 2015 Feb;62(2):143-57. doi: 10.1007/s12630-014-0273-z. Epub 2014 Nov 25.
PubMed 25420470Desserud KF, Veen T, Soreide K. Emergency general surgery in the geriatric patient. Br J Surg. 2016 Jan;103(2):e52-61. doi: 10.1002/bjs.10044. Epub 2015 Dec 1.
PubMed 26620724Lin HS, McBride RL, Hubbard RE. Frailty and anesthesia - risks during and post-surgery. Local Reg Anesth. 2018 Oct 5;11:61-73. doi: 10.2147/LRA.S142996. eCollection 2018.
PubMed 30323657Dasgupta M, Dumbrell AC. Preoperative risk assessment for delirium after noncardiac surgery: a systematic review. J Am Geriatr Soc. 2006 Oct;54(10):1578-89. doi: 10.1111/j.1532-5415.2006.00893.x.
PubMed 17038078Peters LL, Boter H, Buskens E, Slaets JP. Measurement properties of the Groningen Frailty Indicator in home-dwelling and institutionalized elderly people. J Am Med Dir Assoc. 2012 Jul;13(6):546-51. doi: 10.1016/j.jamda.2012.04.007. Epub 2012 May 12.
PubMed 22579590Bielderman A, van der Schans CP, van Lieshout MR, de Greef MH, Boersma F, Krijnen WP, Steverink N. Multidimensional structure of the Groningen Frailty Indicator in community-dwelling older people. BMC Geriatr. 2013 Aug 22;13:86. doi: 10.1186/1471-2318-13-86.
PubMed 23968433Steverink N, Slaets J, Schuurmans H, van Lis M. Measuring frailty: developing and testing of the Groningen frailty indicator (GFI). Gerontologist. 2001;41:236-237
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Association of Different Frailty Scores to the Incidence of Post-operative Delirium and Cognitive Dysfunction
- ClinicalTrials.gov ID
- NCT04056871
- Acronym / sponsor ID
- U1111-1237-9788
- Keywords
- post-operative delirium, post-operative cognitive dysfunction, frailty, nutritional status, depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 14 Aug 2019 (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.
Patients who are frail will have higher rate for post-operative morbidities, mortality, prolonged hospital stays, loss of independence, increase in institutionalization, post-operative cognitive dysfunction (POCD) and delirium (POD).
So, it is crucial to find a suitable frailty assessment tool that can be incorporated into a guideline and reference for our local setting in geriatric peri-operative management. In the mean time, create awareness regarding the frailty elderly population with POD, POCD and other associated poor outcomes among our clinicians.
Detailed description
Increasing life expectancy has led to increase in elderly populations, thus the elderly patients amounting for greater proportion of surgical cases. But, most of them are frail with multiple co-morbidities and are exposed to adverse outcome post-operatively. The commonest adverse outcomes is post-operative delirium (POD) in which clinicians often miss and often take lightly. If it is not treated, it will progress to post-operative cognitive dysfunction (POCD).
So, it is crucial to identify the risk factors pre-operatively to minimize the risk of POD and POCD. The frail patients are more likely to have pre-existing cognitive impairment with reduced cognitive reserve, hence, they are the most vulnerable to POCD and POD. One of the most commonly used frailty screening tools is Fried Frailty criteria which is an easily accessible tool that mainly screens and scores the patients physically. However, the investigators propose to use the Groningen Frailty scale as it can assess the patients in a more holistic approach, not only in physical, but also vision, heating, nutritional, co-morbidities, cognition, psychosocial and mobility of the patients.
Method:
Elderly patients >65 years old undergoing elective surgery under general or local anaesthesia in University Malaya Medical Centre will be recruited for this study, over a 6 months period from August 2019 to January 2020. Patients will be assessed with baseline cognitive assessment, nutritional status, psychological status, and frailty scores prior to the surgery. After the operation, patients will be assessed using 4AT and CAM for at least 5 days or until patients discharged. Cognitive functions will be assessed on post-operative 7th day, 1 month and 3 months with T-MOCA via phone.
All data will be analyzed using SPSS.
Impact of research:
A suitable frailty assessment tool will be identified to be used pre-operatively for elderly patients undergoing elective surgery. This tool will then be incorporated into a guideline and reference in our local setting for geriatric peri-operative management protocol.
Moreover, with the results, investigators hope to create awareness within our multidisciplinary care of elderly surgical population on frailty assessment and its correlation to post-operative delirium, cognitive dysfunction and associated poor outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fried Frailty Phenotype | – | Diagnostic Test: Frailty Screening ToolsThis group of patients will be assess by using 5 characteristics of Frailty which are weight loss, weakness, exhaustion, low activity and physical fitness of the patients. Patients classify as frail will have more than 3 criteria, intermediate or pre-frail will be 1 or 2 criteria present and robust will not have criteria. |
| Groningen Frailty Index | – | Diagnostic Test: Frailty Screening ToolsGFI is a simple questionnaire consisting of 15 items which are classified into 8 groups, consistent of 4 domains of functioning. A score of 4 or more indicates a higher risk for frailty and possible delirium. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All patients above 65 years of age undergoing elective surgery under anesthetic care for both general and regional anesthesia with or without sedation.
Key inclusion criteria (7 listed)
- Age 65 years old and above
- ASA 1 - 3
- Full GCS
- Elective surgery
- Able to communicate well
Key exclusion criteria (6 listed)
- Cardiac and neurosurgery
- On drugs affecting the central nervous system
- Admission to ICU intubated to continue ventilation.
- Refusal of consent
- Severe hearing loss
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 |
|---|---|---|
| Frailty Screening ToolsThis is an observational and prospective study of patients who are going for elective surgery, thus no intervention will be given. | Diagnostic test | Fried Frailty Phenotype, Groningen Frailty Index |
Primary outcome
Occurence of confusion using Confusion Assessment Method (CAM) scores
Time frame: Within 5 days after surgery
Delirium is present if the following are present: Feature 1-Acute Change or/and Fluctuation (any symptom) AND Feature 2-Inattention AND EITHER Feature 3-Disorganized Thinking OR Feature 4-Altered Level of Consciousness
Change in cognitive function using Telephone-Montreal Cognitive Assessment (T-MOCA)
Time frame: Within 1 month
Cognitive function of the patients will be assessed after discharged and must achieved post-operative day 7 with T-MOCA via phone, subsequently assessed at 1 month and 3 month later.
Occurence of delirium using 4AT scores
Time frame: Within 5 days after surgery
A score of 4 or more suggests delirium but is not diagnostic: more detailed assessment of mental status may be required to reach a diagnosis. A score of 1-3 suggests cognitive impairment and more detailed cognitive testing and informant history-taking are required. A score of 0 does not definitively exclude delirium or cognitive impairment: more detailed testing may be required depending on the clinical context.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
- Background: PubMed 23395245Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.
- Background: PubMed 21093718Xue QL. The frailty syndrome: definition and natural history. Clin Geriatr Med. 2011 Feb;27(1):1-15. doi: 10.1016/j.cger.2010.08.009.
- BackgroundPeri-operative Care for Older Patients Undergoing Surgery. British Geriatrics Society. http://www.bgs.org.uk/index.php/topresources/publicationfind/goodpractice/2402-bpg-pops (cited November 2015
- Background: PubMed 20510798Makary MA, Segev DL, Pronovost PJ, Syin D, Bandeen-Roche K, Patel P, Takenaga R, Devgan L, Holzmueller CG, Tian J, Fried LP. Frailty as a predictor of surgical outcomes in older patients. J Am Coll Surg. 2010 Jun;210(6):901-8. doi: 10.1016/j.jamcollsurg.2010.01.028. Epub 2010 Apr 28.
- Background: PubMed 11253156Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
- Background: PubMed 22881367Collard RM, Boter H, Schoevers RA, Oude Voshaar RC. Prevalence of frailty in community-dwelling older persons: a systematic review. J Am Geriatr Soc. 2012 Aug;60(8):1487-92. doi: 10.1111/j.1532-5415.2012.04054.x. Epub 2012 Aug 6.
- Background: PubMed 19567825Fried LP, Xue QL, Cappola AR, Ferrucci L, Chaves P, Varadhan R, Guralnik JM, Leng SX, Semba RD, Walston JD, Blaum CS, Bandeen-Roche K. Nonlinear multisystem physiological dysregulation associated with frailty in older women: implications for etiology and treatment. J Gerontol A Biol Sci Med Sci. 2009 Oct;64(10):1049-57. doi: 10.1093/gerona/glp076. Epub 2009 Jun 30.
- Background: PubMed 25199821Sepehri A, Beggs T, Hassan A, Rigatto C, Shaw-Daigle C, Tangri N, Arora RC. The impact of frailty on outcomes after cardiac surgery: a systematic review. J Thorac Cardiovasc Surg. 2014 Dec;148(6):3110-7. doi: 10.1016/j.jtcvs.2014.07.087. Epub 2014 Aug 7.
- Background: PubMed 25420470Beggs T, Sepehri A, Szwajcer A, Tangri N, Arora RC. Frailty and perioperative outcomes: a narrative review. Can J Anaesth. 2015 Feb;62(2):143-57. doi: 10.1007/s12630-014-0273-z. Epub 2014 Nov 25.
- Background: PubMed 26620724Desserud KF, Veen T, Soreide K. Emergency general surgery in the geriatric patient. Br J Surg. 2016 Jan;103(2):e52-61. doi: 10.1002/bjs.10044. Epub 2015 Dec 1.
- Background: PubMed 30323657Lin HS, McBride RL, Hubbard RE. Frailty and anesthesia - risks during and post-surgery. Local Reg Anesth. 2018 Oct 5;11:61-73. doi: 10.2147/LRA.S142996. eCollection 2018.
- Background: PubMed 17038078Dasgupta M, Dumbrell AC. Preoperative risk assessment for delirium after noncardiac surgery: a systematic review. J Am Geriatr Soc. 2006 Oct;54(10):1578-89. doi: 10.1111/j.1532-5415.2006.00893.x.
- 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. This study is not recruiting at the moment.
Pui San Loh principal investigator
University of Malaya
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 Frail Elderly Syndrome and Postoperative Delirium, run by University of Malaya at 1 site in Malaysia.
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 7 inclusion and 6 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: finished, as of the sponsor's last update on 30 Apr 2020. 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 Malaysia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurence of confusion using Confusion Assessment Method (CAM) scores (time frame: Within 5 days after surgery). The study lists 3 primary outcomes in all. 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 NCT04056871, which also lists 53 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 30 Apr 2020.