Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000736347
Ethics application status
Approved
Date submitted
12/05/2017
Date registered
19/05/2017
Date last updated
30/04/2019
Date data sharing statement initially provided
30/04/2019
Date results information initially provided
30/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Stress in people recovering from stroke
Scientific title
Development and implementation of improved monitoring of psychological stress loads in people recovering from stroke.
Secondary ID [1] 291896 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 303263 0
Condition category
Condition code
Stroke 302684 302684 0 0
Ischaemic
Stroke 302685 302685 0 0
Haemorrhagic

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The purpose of the study is to find out if stress impacts a person’s ability to recover from a stroke. The study will monitor stress levels in people who have had stroke in the last 12 months or longer to determine how their recovery is progressing, and whether they are experiencing significant stress levels.

Participants with stroke in the last 12 months will be recruited through social media advertisements, radio, stroke community groups and the Hunter Stroke Research Volunteer Register. Healthy age matched controls will be recruited from the Hunter Medical Research Institute volunteer register.

Participants will require to visit Hunter Medical Research Institute for one-off appointment with the researchers. Participants will provide a blood sample and hair sample for the analysis of stress hormones. Participants will also complete a list of surveys including clinical and anthropometrics details; Perceived stress (Perceived Stress Scale), Cognition (CANTAB, particularly subscales directed towards sustained attention and executive function); Fatigue (Fatigue Assessment Scale); Resiliency (using the CD-RISC and the BRS) and Recovery (Stroke Impact Scale for participants with stroke only),
Intervention code [1] 298053 0
Early Detection / Screening
Comparator / control treatment
Age matched control
Control group
Active

Outcomes
Primary outcome [1] 302092 0
Stress as assessed by Perceived Stress Scale (PSS), hair cortisol level and blood cortisol levels (composite outcome)
Timepoint [1] 302092 0
Assessed at single baseline timepoint only
Secondary outcome [1] 334715 0
Changes in cognition scores as assessed by CANTAB battery of tests, particularly in those people who suffer severe strokes
Timepoint [1] 334715 0
Assessed at single baseline timepoint only
Secondary outcome [2] 346683 0
Changes in resilience scores as assessed by Connor-Davidson Resilience Scale and Brief Resilience Scale, particularly in those people who suffer severe strokes
Timepoint [2] 346683 0
Assessed at single baseline timepoint only
Secondary outcome [3] 346684 0
Changes in fatigue scores as assessed by Fatigue Assessment Scale , particularly in those people who suffer severe strokes
Timepoint [3] 346684 0
Assessed at single baseline timepoint only
Secondary outcome [4] 346685 0
Changes in stroke impact scores as assessed by Stroke Impact Scale
Timepoint [4] 346685 0
Assessed at single baseline timepoint only

Eligibility
Key inclusion criteria
Participants with stroke who:
have had a stroke in the last 12 months or longer
no previous history of pituitary and adrenal gland diseases

Age-match controls are participants:
without medical history of stroke
do not have any previous medical history of adrenal and pituitary gland diseases
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants are discharged to a high dependency medical care environment, have a language other than English as their first language, have a previous history of pituitary or adrenal disease (Cushing or Addison’s).

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Analysis of the data will be undertaken with support from the HMRI Statistical Support Unit. The required N is 70 per group.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
31/07/2017
Actual
9/10/2017
Date of last participant enrolment
Anticipated
31/07/2020
Actual
24/01/2019
Date of last data collection
Anticipated
31/07/2020
Actual
Sample size
Target
140
Accrual to date
Final
140
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7998 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 15978 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 296399 0
Other
Name [1] 296399 0
Hunter Medical Research Institute
Country [1] 296399 0
Australia
Funding source category [2] 299435 0
Charities/Societies/Foundations
Name [2] 299435 0
John Hunter Hospital Charitable Trust Fund
Country [2] 299435 0
Australia
Primary sponsor type
Other
Name
Hunter Stroke Service
Address
Hunter Stroke Service
Level 1, The Lodge
Lookout Road
John Hunter Hospital
New Lambton Heights
New South Wales
2305
Country
Australia
Secondary sponsor category [1] 295389 0
None
Name [1] 295389 0
Address [1] 295389 0
Country [1] 295389 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297628 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 297628 0
John Hunter Hospital
Lookout Road
New Lambton Heights
New South Wales
2305
Ethics committee country [1] 297628 0
Australia
Date submitted for ethics approval [1] 297628 0
31/05/2017
Approval date [1] 297628 0
18/07/2017
Ethics approval number [1] 297628 0
17/06/21/4.02

Summary
Brief summary
This cross sectional study will be conducted on stroke survivors with a diagnosis of stroke in the last 12 months or longer. This study will aim to determine the stress levels in patients with stroke. This information will be compared with age matched control participants to determine the differences in stress levels between stroke survivors and the control population.

This study aims to measure subjective and biological stress loads in patients recovering from stroke, 12 months or longer post event, and to explore the relationship between chronic stress, in stroke patients compared to age matched controls.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74642 0
A/Prof Frederick Rohan Walker
Address 74642 0
Hunter Medical Research Institute
Kookaburra Circuit
New Lambton Heights
New South Wales
2305
Country 74642 0
Australia
Phone 74642 0
+612 40420000
Fax 74642 0
Email 74642 0
[email protected]
Contact person for public queries
Name 74643 0
Frederick Rohan Walker
Address 74643 0
Hunter Medical Research Institute
Kookaburra Circuit
New Lambton Heights
New South Wales
2305
Country 74643 0
Australia
Phone 74643 0
+612 40420000
Fax 74643 0
Email 74643 0
[email protected]
Contact person for scientific queries
Name 74644 0
Frederick Rohan Walker
Address 74644 0
Hunter Medical Research Institute
Kookaburra Circuit
New Lambton Heights
New South Wales
2305
Country 74644 0
Australia
Phone 74644 0
+612 40420000
Fax 74644 0
Email 74644 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date determined
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Conference abstractNo https://www.ahajournals.org/doi/abs/10.1161/str.50... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseOpposing Associations of Stress and Resilience With Functional Outcomes in Stroke Survivors in the Chronic Phase of Stroke: A Cross-Sectional Study.2020https://dx.doi.org/10.3389/fneur.2020.00230
N.B. These documents automatically identified may not have been verified by the study sponsor.