Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12622001238763
Ethics application status
Approved
Date submitted
29/08/2022
Date registered
14/09/2022
Date last updated
14/09/2022
Date data sharing statement initially provided
14/09/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
A UK Biobank analysis to assess the outcomes of frailty in people with severe mental illness
Query!
Scientific title
Towards a better understanding of frailty in people with severe mental illness: a longitudinal analysis of the UK Biobank
Query!
Secondary ID [1]
307354
0
81605
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
frailty
326651
0
Query!
schizophrenia
326652
0
Query!
bipolar disorder
326653
0
Query!
major depressive disorder
326654
0
Query!
anxiety disorders
326655
0
Query!
multimorbidity
326665
0
Query!
mortality
326666
0
Query!
Condition category
Condition code
Public Health
323892
323892
0
0
Query!
Epidemiology
Query!
Mental Health
323894
323894
0
0
Query!
Schizophrenia
Query!
Mental Health
323895
323895
0
0
Query!
Other mental health disorders
Query!
Mental Health
323896
323896
0
0
Query!
Depression
Query!
Mental Health
323904
323904
0
0
Query!
Anxiety
Query!
Metabolic and Endocrine
323905
323905
0
0
Query!
Diabetes
Query!
Cardiovascular
323906
323906
0
0
Query!
Coronary heart disease
Query!
Respiratory
323907
323907
0
0
Query!
Other respiratory disorders / diseases
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
False
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
Description of intervention(s) / exposure
Participants include all 502,412 subjects assessed at the baseline phase of the UK Biobank study. Baseline assessment occurred from 13 March 2006 to 1 October 2010.
For time-to-event analyses, we will obtain data on all-cause mortality from Data-Field 40000 of the UK Biobank study: https://biobank.ctsu.ox.ac.uk/crystal/field.cgi?id=40000. Data on the deaths of UK Biobank participants comes from NHS Digital for participants in England & Wales and from the NHS Central Register, part of the National Records of Scotland, for participants in Scotland (see https://biobank.ctsu.ox.ac.uk/crystal/ukb/docs/DeathLinkage.pdf).
In the time-to-event analysis of all-cause mortality, we will left-censor three subjects who have a date of death before study entry. We will right censor at 12 November 2021, which is the last date of death in the dataset.
We will derive information on mental and behavioural disorders, subjects' Hospital Frailty Risk Score, and subjects' Charlson Comorbidity Index Score, from record-level inpatient data on ICD-10 Diagnosis codes (ICD-9 or ICD-10) relating to the inpatient episode of
care for England, Wales and Scotland.
Data on diagnoses occurring during hospital inpatient admissions in England come from the Data Access Request Service, managed by NHS Digital. The dataset is called Hospital Episode Statistics Admitted Patient Care (see page 3 of https://biobank.ctsu.ox.ac.uk/crystal/ukb/docs/DeathLinkage.pdf).
Data on diagnoses occurring during hospital inpatient admissions in Wales comes from the Secure Anonymised Information Linkage Databank at the University of Swansea, managed by
NHS Wales Informatics Service's Information Services Division. The dataset is called
Patient Episode Database for Wales Admitted Patient Care (see https://biobank.ctsu.ox.ac.uk/crystal/refer.cgi?id=138483).
Data on diagnoses occurring during hospital inpatient stays in Scotland come from the electronic Data Research and Innovation Service, managed by Information Services Division Scotland part of NHS National Services Scotland. This dataset is called General Acute Inpatient and Day Case - Scottish Morbidity Record (see https://biobank.ctsu.ox.ac.uk/crystal/refer.cgi?id=138483).
We will not left-censor any of these conditions, but will right-censor them at 1 October 2010, the last date of assessment for any UK Biobank participant in the baseline assessment period.
The UK Biobank study has a protocol available for viewing online at https://www.ukbiobank.ac.uk/learn-more-about-uk-biobank/about-us
We will observe in participants mental and behavioural disorders, frailty (using three measures) and comorbidity (using one measure) and mortality.
This study involves no active participation for participants, as all data comes from previous UK Biobank assessments or hospital episode or death register records linked to UK Biobank.
After baseline observation from 13 March 2006 to 1 October 2010, there will only be follow-up data on all-cause mortality as deaths occur.
Query!
Intervention code [1]
323785
0
Diagnosis / Prognosis
Query!
Comparator / control treatment
Comparison groups will include:
Participants who did enrol into the UK Biobank study but who do not have an ICD-10 diagnosis of a severe mental illness (schizophrenia, bipolar or moderate to severe single or recurrent depressive episodes).
Participants who did enrol into the UK Biobank study but who do not have an ICD-10 diagnosis of a mental or behavioural disorder.
The data on hospital episode statistics recording mental and behavioural disorders come from these data sources:
Those occurring during hospital inpatient admissions in England come from the Data Access Request Service, managed by NHS Digital. The dataset is called Hospital Episode Statistics Admitted Patient Care (see page 3 of https://biobank.ctsu.ox.ac.uk/crystal/ukb/docs/DeathLinkage.pdf). The time period starts on 1 January 1997 and ends on 1 October 2010.
Data on diagnoses occurring during hospital inpatient admissions in Wales comes from the Secure Anonymised Information Linkage Databank at the University of Swansea, managed by NHS Wales Informatics Service's Information Services Division. The dataset is called
Patient Episode Database for Wales Admitted Patient Care (see https://biobank.ctsu.ox.ac.uk/crystal/refer.cgi?id=138483). The time period starts on 1 January 1998 and ends on 1 October 2010.
The Scottish Morbidity Record does not yet have mental health hospital admissions.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
331709
0
Frailty, assessed with:
The 49-item Frailty Index, as derived in Williams, D. M., Jylhävä, J., Pedersen, N. L., & Hägg, S. (2019). A frailty index for UK Biobank participants. The Journals of Gerontology: Series A, 74(4), 582-587.
Query!
Assessment method [1]
331709
0
Query!
Timepoint [1]
331709
0
Baseline: Initial assessment visit (2006-2010) at which participants were recruited and consent given. This is the cross-sectional component of this project, which will right-censor the Hospital Frailty Risk Score at 1 October 2010.
Query!
Primary outcome [2]
331710
0
Frailty, assessed with the 109-item Hospital Frailty Risk Score, as derived in Mak, J. K., Kuja-Halkola, R., Wang, Y., Hägg, S., & Jylhävä, J. (2021). Frailty and comorbidity in predicting community COVID-19 mortality in the UK Biobank: The effect of sampling. Journal of the American Geriatrics Society, 69(5), 1128-1139.
Query!
Assessment method [2]
331710
0
Query!
Timepoint [2]
331710
0
Baseline: Initial assessment visit (2006-2010) at which participants were recruited and consent given. This is the cross-sectional component of this project, which will right-censor the Hospital Frailty Risk Score at 1 October 2010.
Query!
Primary outcome [3]
332534
0
Frailty, assessed with:
The 5-item Physical Frailty Phenotype, as derived in Mak, J. K., Kuja-Halkola, R., Wang, Y., Hägg, S., & Jylhävä, J. (2021). Frailty and comorbidity in predicting community COVID-19 mortality in the UK Biobank: The effect of sampling. Journal of the American Geriatrics Society, 69(5), 1128-1139
Query!
Assessment method [3]
332534
0
Query!
Timepoint [3]
332534
0
Initial assessment visit (2006-2010) at which participants were recruited and consent given. This is the cross-sectional component of this project, which will right-censor the Hospital Frailty Risk Score at 1 October 2010.
Query!
Secondary outcome [1]
410835
0
An ICD-10 diagnosis of diabetes, as derived from hospital episode statistics on ICD-10 diagnoses assigned in the primary or secondary position during hospital admissions.
Query!
Assessment method [1]
410835
0
Query!
Timepoint [1]
410835
0
As diabetes diagnoses occurred, using linked hospital admissions data. UK Biobank receives hospital inpatient data from each data provider approximately annually (https://biobank.ctsu.ox.ac.uk/crystal/ukb/docs/HospitalEpisodeStatistics.pdf). The data linkage means that our investigatory team will assess these once, when UK Biobank data is extracted, and include diagnoses occurring up to and including the 30 September 2021.
Query!
Secondary outcome [2]
410836
0
An ICD-10 diagnosis of cardiovascular disease, as derived from hospital episode statistics on ICD-10 diagnoses assigned in the primary or secondary position during hospital admissions.
Query!
Assessment method [2]
410836
0
Query!
Timepoint [2]
410836
0
As cardiovascular disease diagnoses occurred, using linked hospital admissions data. UK Biobank receives hospital inpatient data from each data provider approximately annually (https://biobank.ctsu.ox.ac.uk/crystal/ukb/docs/HospitalEpisodeStatistics.pdf). The data linkage means that our investigatory team will assess these once, when UK Biobank data is extracted, and include diagnoses occurring up to and including the 30 September 2021.
Query!
Secondary outcome [3]
410837
0
An ICD-10 diagnosis of chronic lung disease, as derived from hospital episode statistics on ICD-10 diagnoses assigned in the primary or secondary position during hospital admissions.
Query!
Assessment method [3]
410837
0
Query!
Timepoint [3]
410837
0
As chronic lung disease diagnoses occurred, using linked hospital admissions data. UK Biobank receives hospital inpatient data from each data provider approximately annually (https://biobank.ctsu.ox.ac.uk/crystal/ukb/docs/HospitalEpisodeStatistics.pdf). The data linkage means that our investigatory team will assess these once, when UK Biobank data is extracted, and include diagnoses occurring up to and including the 30 September 2021.
Query!
Secondary outcome [4]
413838
0
All-cause mortality
Query!
Assessment method [4]
413838
0
Query!
Timepoint [4]
413838
0
As death occurred, using linked data from National Death Registries in England, Scotland and Wales. UK Biobank currently receives new data on mortality from NHS Digital and the NHS Central Register every month (https://biobank.ctsu.ox.ac.uk/crystal/ukb/docs/DeathLinkage.pdf). The last date of death in the dataset is the outcome endpoint. The data linkage means that our investigatory team will assess these once, when UK Biobank data is extracted, and include deaths occurring up to and including the 12 November 2021: https://biobank.ctsu.ox.ac.uk/crystal/field.cgi?id=40000
Query!
Eligibility
Key inclusion criteria
Participants in the UK Biobank study, as this is a secondary data analysis of that dataset. The UK Biobank Study Protocol is available at https://www.ukbiobank.ac.uk/learn-more-about-uk-biobank/about-us
Query!
Minimum age
37
Years
Query!
Query!
Maximum age
73
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
None.
Query!
Study design
Purpose
Natural history
Query!
Duration
Longitudinal
Query!
Selection
Defined population
Query!
Timing
Both
Query!
Statistical methods / analysis
The prevalence of frailty will be reported using descriptive statistics as means and standard deviations or numbers and percentages as appropriate. Sociodemographic characteristics and long-term conditions will be examined across frail, pre-frail, and non-frail participants using chi-square (or Fisher’s exact) test for categorical variables and Kruskal-Wallis test for continuous variables. Subsequently, all significant variables from the descriptive analysis will be entered into multinomial logistic regression to assess the probability of a specific outcome. Odds ratios for pre-frail and frail group will be compared separately with that of the non-frail participants. This analysis will be conducted for participants with severe mental illness and for each group of mental disorders separately. Association of frailty status with the risk time of to developing any of the long-term conditions and of or all-cause mortality will be measured using Kaplan–Meier survival curves and Cox regression to calculate adjusted hazard ratios. was assessed using Cox proportional hazards regression models . The models will be adjusted for relevant variables, including sex, age, ethnicity, employment, income, smoking status, body mass index (BMI), and being born overseas, which are known to impact either the prevalence of mental disorder or frailty.
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
30/09/2022
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
30/09/2022
Query!
Actual
Query!
Date of last data collection
Anticipated
30/09/2022
Query!
Actual
Query!
Sample size
Target
500000
Query!
Accrual to date
Query!
Final
Query!
Recruitment outside Australia
Country [1]
24838
0
United Kingdom
Query!
State/province [1]
24838
0
Query!
Funding & Sponsors
Funding source category [1]
311640
0
University
Query!
Name [1]
311640
0
The University of Queensland (UQ) Academy of Psychiatry top-up research funds
Query!
Address [1]
311640
0
K Floor, Mental Health Centre
Royal Brisbane & Women’s Hospital
Cnr Butterfield St and Bowen Bridge Road
Herston, Queensland, 4029 Australia
Query!
Country [1]
311640
0
Australia
Query!
Primary sponsor type
University
Query!
Name
The University of Queensland
Query!
Address
Sir Fred Schonell Dr., Brisbane, Queensland 4072
Query!
Country
Australia
Query!
Secondary sponsor category [1]
313083
0
None
Query!
Name [1]
313083
0
Query!
Address [1]
313083
0
Query!
Country [1]
313083
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
311096
0
Metro South Human Research Ethics Committee
Query!
Ethics committee address [1]
311096
0
Translational Research Institute, Princess Alexandra Hospital Campus, Metro South Health
Level 7, TRI, 37 Kent Street, Woolloongabba Qld 4102
Query!
Ethics committee country [1]
311096
0
Australia
Query!
Date submitted for ethics approval [1]
311096
0
Query!
Approval date [1]
311096
0
01/01/2022
Query!
Ethics approval number [1]
311096
0
Query!
Summary
Brief summary
Provision of mental health services to people with mental illness is associated with high health care costs and characterised by a complex presentation of people with severe mental illness such as schizophrenia, bipolar disorder and severe major depression. To improve health and services for this population, a more holistic approach, one that considers a patient’s physical and nutritional status, mental health and cognition, is needed. Indeed, recent evidence suggests that people with severe mental illness are at higher risk for frailty, a condition caused by the decline in reserve and function across multiple physiologic systems. To date, programs targeting directly frailty directly have demonstrated improvement in outcomes such as increased physical and cognitive functioning, decreased hospitalisation rates and improved quality of life (1). In people with mental illness, frailty has mostly been explored in those with late-life depression and anxiety, which has led to the development of multimodal interventions targeting lifestyle factors and multidisciplinary care. To date, frailty has been minimally investigated in those with severe mental illness.
Through cross-disciplinary collaborations, our team of skilled early career and clinical researchers, with track record investigating frailty and health outcomes in people with severe mental illness, will enable a rapid translation of the study outcomes into health care policy and clinical practice. By accessing longitudinal data of the UK Biobank, a large-scale biomedical database and research resource, containing in-depth health information from half a million participants, the proposed research is uniquely placed to expand our understanding of frailty in people with severe mental illness. This novel information will inform the development of interventions tailored to the unique needs of this cohort.
The UK Biobank protocol is available online: https://www.ukbiobank.ac.uk/learn-more-about-uk-biobank/about-us
(1) Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001;56(3):146-56.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
119930
0
Prof Dan Siskind
Query!
Address
119930
0
Woolloongabba Community Health Centre
Level 2 Mental Health, 228 Logan Rd
Woolloongabba, QLD, 4102 AUSTRALIA
Query!
Country
119930
0
Australia
Query!
Phone
119930
0
+61733171040
Query!
Fax
119930
0
+61733171298
Query!
Email
119930
0
[email protected]
Query!
Contact person for public queries
Name
119931
0
Prof Dan Siskind
Query!
Address
119931
0
Woolloongabba Community Health Centre
Level 2 Mental Health, 228 Logan Rd
Woolloongabba, QLD, 4102 AUSTRALIA
Query!
Country
119931
0
Australia
Query!
Phone
119931
0
+61733171040
Query!
Fax
119931
0
+61733171298
Query!
Email
119931
0
[email protected]
Query!
Contact person for scientific queries
Name
119932
0
Prof Dan Siskind
Query!
Address
119932
0
Woolloongabba Community Health Centre
Level 2 Mental Health, 228 Logan Rd
Woolloongabba, QLD, 4102 AUSTRALIA
Query!
Country
119932
0
Australia
Query!
Phone
119932
0
+61733171040
Query!
Fax
119932
0
+61733171298
Query!
Email
119932
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF