Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000058875
Ethics application status
Approved
Date submitted
22/08/2020
Date registered
25/01/2021
Date last updated
25/01/2021
Date data sharing statement initially provided
25/01/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The D-Frail Study 1: Association between vascular endothelial dysfunction and physical frail in patients with cardiovascular comorbidities: A prospective crossectional cohort study
Scientific title
The D-Frail Study 1: Association between vascular endothelial dysfunction and physical frail in patients with cardiovascular comorbidities: A prospective crossectional cohort study – Interplay between vitamin D deficiency, chronic inflammation and sarcopenia
Secondary ID [1] 301646 0
Nil Known
Universal Trial Number (UTN)
U1111-1254-3879
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical frailty 318057 0
Sarcopenia 318058 0
Cognitive frailty 318059 0
Vascular endothelial dysfunction 318060 0
Condition category
Condition code
Cardiovascular 316090 316090 0 0
Other cardiovascular diseases
Musculoskeletal 316091 316091 0 0
Other muscular and skeletal disorders
Mental Health 316092 316092 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A single-centred, prospective cross-sectional analytical study will be carried out. Patients with diagnosed Cardiovascular disease conditions will be recruited from outpatient clinics of acute care hospital. Written informed consent will be taken from all patients who are willing to participate the study at screening stage. At the time of enrolment to the study, the participants will be given a unique study identification number, which will be used to identify the participants throughout the study, until study completion. No identifiable information will be used in the records. Study master list with identifiers will be securely kept separately from the list of unique IDs given to the participants and study data records. The participants will be screened for their frailty states (30 min clinical assessment involving muscle strength assessment by hand grip strength measurement, physical and cognitive function assessments, dietary intake of vitamin D and sun exposure levels assessments by questionnaires) and blood tests to assess vascular function and inflammatory markers and plasma vitamin D levels.
Intervention code [1] 319075 0
Not applicable
Comparator / control treatment
Singled armed
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324873 0
Sarcopenia assessed by hand grip strength measured by hand-held Dynamometer
Timepoint [1] 324873 0
At single assessment point
Primary outcome [2] 324874 0
Vascular endothelial dysfunction measured by blood plasma markers (Asymmetric dimethylarginine [ADMA] and Thrombospondin 1 [TSP 1]) level measured by Enzyme linked immunosorbent assay (ELISA)
Timepoint [2] 324874 0
At single assessment point
Primary outcome [3] 326078 0
Inflammation assessed by plasma inflammatory markers (IL-6, hs-CRP) measured by ELISA
Timepoint [3] 326078 0
At single assessment point
Secondary outcome [1] 386054 0
Cognitive frailty assessed by MiniCog assessment method at single assessment point
Timepoint [1] 386054 0
At single assessment point
Secondary outcome [2] 386055 0
Plasma vitamin D level measured by ELISA
Timepoint [2] 386055 0
At single assessment point

Eligibility
Key inclusion criteria
Age greater than or equal to 45 years,
Diagnosed with cardiovascular condition
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosed renal/liver diseases
Pregnant or breastfeeding
Severe cognitive impairment (i.e. dementia/alzheimer's disease)
Diagnosed musculoskeletal disorders
Unable to communicate without an interpreter

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
Descriptive analysis will be carried-out to assess the demographic and situational data.
Study participants will be stratified to sarcopenic and non-sarcopenic based on accepted cut-off points.
Data from sarcopenic and non-sarcopenic sub groups will be evaluated by t-tests (un-paired)/Mann–Whitney U test, linear regression analysis and multivariate logistic regression to evaluate the independent effects.
Study 1: Data will be stratified based on vitamin D status and frailty/sarcopenic status.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/01/2021
Actual
Date of last participant enrolment
Anticipated
1/05/2021
Actual
Date of last data collection
Anticipated
1/05/2021
Actual
Sample size
Target
183
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 17306 0
Blacktown Hospital - Blacktown
Recruitment postcode(s) [1] 31032 0
2148 - Blacktown

Funding & Sponsors
Funding source category [1] 306080 0
Other Collaborative groups
Name [1] 306080 0
The Sydney Partnership for Health, Education, Research and Enterprise (SPHERE), Cardiac and Vascular Health Clinical Academic Group - Early/Mid research career Seed Grant fund (2019-2021)
Country [1] 306080 0
Australia
Funding source category [2] 306525 0
Other
Name [2] 306525 0
Blackmores Institute
Country [2] 306525 0
Australia
Primary sponsor type
Government body
Name
Western Sydney Local Health District
Address
Blacktown Hospital, Western Sydney Local Health District,
Marcel Crescent, Blacktown, NSW, 2148, Australia
Country
Australia
Secondary sponsor category [1] 306542 0
University
Name [1] 306542 0
Western Sydney University
Address [1] 306542 0
Western Sydney University, Research Services, Ground Floor, Building BA, Penrith Campus (Werrington South), Great Western Highway Werrington NSW
2747
NSW, Australia
Country [1] 306542 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306301 0
Western Sydney Local Health District HREC
Ethics committee address [1] 306301 0
WESTERN SYDNEY LOCAL HEALTH DISTRICT, Research Office, Level 2, REN Building Westmead Hospital, Hawkesbury & Darcy Roads, Westmead NSW 2145
Ethics committee country [1] 306301 0
Australia
Date submitted for ethics approval [1] 306301 0
14/05/2020
Approval date [1] 306301 0
18/08/2020
Ethics approval number [1] 306301 0
2020/ETH01551

Summary
Brief summary
The WSLHD HREC has approved project, certifying that the study proposal meets the requirements of the National Statement. The ethical approval for this research project is granted to be conducted at Blacktown Mount Druitt Hospital.
The WSLHD HREC has been accredited by the NSW Department of Health as a lead HREC to provide the single ethical and scientific review of proposals to conduct research within the NSW public health system. This lead HREC is constituted and operates in accordance with the National Health and Medical Research Council’s National Statement on Ethical Conduct in Human Research and the CPMP/ICH Note for Guidance on Good Clinical Practice.
The request to undertake the above protocol was reviewed by a subcommittee of members of the Scientific Advisory Committee (SAC) and the Human Research Ethics Committee (HREC) (Western Sydney Local Health District).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103422 0
Dr Anjalee Amarasekera
Address 103422 0
Blacktown Clinical and Research School, Western Sydney University, Marcel Crescent, Blacktown Hospital, NSW, 2148, Australia
Country 103422 0
Australia
Phone 103422 0
+61 400225593
Fax 103422 0
Email 103422 0
[email protected]
Contact person for public queries
Name 103423 0
Anjalee Amarasekera
Address 103423 0
Blacktown Clinical and Research School, Western Sydney University, Marcel Crescent, Blacktown Hospital, NSW, 2148, Australia
Country 103423 0
Australia
Phone 103423 0
+61 400225593
Fax 103423 0
Email 103423 0
[email protected]
Contact person for scientific queries
Name 103424 0
Anjalee Amarasekera
Address 103424 0
Blacktown Clinical and Research School, Western Sydney University, Marcel Crescent, Blacktown Hospital, NSW, 2148, Australia
Country 103424 0
Australia
Phone 103424 0
+61 400225593
Fax 103424 0
Email 103424 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.