Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001475730
Ethics application status
Approved
Date submitted
10/11/2022
Date registered
23/11/2022
Date last updated
23/11/2022
Date data sharing statement initially provided
23/11/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Do fatigue and stress levels affect the quality of life among stroke survivors.
Scientific title
The role of stress in moderating the effects of fatigue on quality of life in stroke survivors: an observational study.
Secondary ID [1] 308389 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 328186 0
Fatigue 328187 0
Stress 328188 0
Condition category
Condition code
Stroke 325240 325240 0 0
Ischaemic
Stroke 325279 325279 0 0
Haemorrhagic
Neurological 325303 325303 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observation of self-reported measures of stress, fatigue, resilience and quality of life and cognitive function assessment (CANTAB) in first time ischemic or hemorrhagic stroke survivors over a period of three months. Participants will take part in a total of four interviews. The first (baseline) and final measures will occur three months apart and consist of a 1 - 1.5 hour face-to-face interview at the participants rehab facility at Baillie Henderson Hospital. These will include use of the perceived stress scale questionnaire, fatigue assessment scale questionnaire, quality of life short form-36 questionnaire, brief resiliency scale and CANTAB. Two additional interviews will be conducted over the phone one month apart between the initial and final interview. These will consist of the fatigue assessment scale questionnaire and perceived stress scale questionnaire only and are estimated to take between 10 to 20 minutes.

In addition to the data collected at interview, de-identified clinical details relevant to the participants stroke event and treatment will be collected from the patient records held by the Health Service. This will include anthropometrics, stroke related clinical details, blood investigations and cardiovascular comorbidities. These clinical details will be specific to the acute stroke care and include clinical details of the stroke event including patient history collected at this point, in addition to clinical details pertaining to acute stroke care which occurs in the three months following stroke event.
Intervention code [1] 324839 0
Diagnosis / Prognosis
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333090 0
Post-stroke fatigue measured using Fatigue Assessment Scale Questionnaire
Timepoint [1] 333090 0
Baseline, 1-month, 2-month, 3-month follow-up.
Primary outcome [2] 333091 0
Stress measured using Perceived Stress Scale Quesionnaire
Timepoint [2] 333091 0
Baseline, 1-month, 2-month, 3-month follow-up.
Primary outcome [3] 333092 0
Quality of Life measured using the Short-form-36 Quality of Life Questionnaire
Timepoint [3] 333092 0
Baseline, 3-month follow-up
Secondary outcome [1] 415758 0
Cognitive function assessment using Cambridge Neuropsychological Test Automated Battery (CANTAB)
Timepoint [1] 415758 0
Baseline and 3-month follow-up
Secondary outcome [2] 415759 0
microRNA expression - extracted from serum sample and assessed using next generation sequencing and real-time polymerase chain reaction.
Timepoint [2] 415759 0
Baseline measure only.

Eligibility
Key inclusion criteria
First time ischemic or haemorrhagic stroke survivors, over three months post-stroke and under three years post-stroke with sufficient grasp of the English language to complete questionnaires.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Stroke survivors who are highly dependent such that they would not be able to participate in interview, or with patient history of multiple stroke events, or for whom stroke event occurred less than 3 months or more than 3 years ago or stroke survivors with insufficient grasp of the English language or aphasia to the extent that questionnaire could not be completed will be excluded.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
4/04/2022
Date of last participant enrolment
Anticipated
30/11/2023
Actual
Date of last data collection
Anticipated
29/02/2024
Actual
Sample size
Target
65
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 23543 0
Baillie Henderson Hospital - Toowoomba
Recruitment postcode(s) [1] 38962 0
4350 - Toowoomba

Funding & Sponsors
Funding source category [1] 312634 0
University
Name [1] 312634 0
University of Southern Queensland
Country [1] 312634 0
Australia
Funding source category [2] 312635 0
Hospital
Name [2] 312635 0
Toowoomba Hospital Foundation
Country [2] 312635 0
Australia
Primary sponsor type
University
Name
University of Southern Queensland
Address
West Street, Toowoomba QLD 4350
Country
Australia
Secondary sponsor category [1] 314248 0
None
Name [1] 314248 0
Address [1] 314248 0
Country [1] 314248 0
Other collaborator category [1] 282484 0
Hospital
Name [1] 282484 0
Darling Downs Health Service
Address [1] 282484 0
Hogg St and, Tor St, Toowoomba City QLD 4350
Country [1] 282484 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311951 0
Darling Downs Health Ethics Committee
Ethics committee address [1] 311951 0
Level 2 Cossart House
Toowoomba Hospital
Toowoomba Qld 4350
Ethics committee country [1] 311951 0
Australia
Date submitted for ethics approval [1] 311951 0
01/06/2021
Approval date [1] 311951 0
05/08/2021
Ethics approval number [1] 311951 0
HREC/2021/QTDD/76118

Summary
Brief summary
The primary aims of this project are to investigate the effects of changes in the levels of perceived stress on the relationship between post-stroke fatigue and quality of life and to explore the relationship between perceived stress and post-stroke fatigue.

The secondary aims of the project are to explore the relationship between post-stroke fatigue and cognitive function and profile the expression of circulating microRNAs in post-stroke fatigue.

The objectives of the study are to measure the baseline and follow-up perceived stress, fatigue, cognitive function and quality of life among 65 recruited stroke survivors over a period of three months and investigate the effects of the change in the level of perceived stress on the relationship between post-stroke fatigue and quality of life. We will also explore the correlation of post-stroke fatigue and perceived stress and the correlation of post-stroke fatigue and cognitive function. From collected blood samples we will profile and identify circulating microRNAs in post-stroke fatigue.

The hypothesis of this project is that:
1. The increase in the level of perceived stress significantly increases the detrimental effect of post-stroke fatigue on quality of life in stroke survivors;
2. The increase in the level of perceived stress significantly increases the level of fatigue over a period of three months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122946 0
Dr Prajwal Gyawali
Address 122946 0
University of Southern Queensland
487-535 West Street
Toowoomba Qld 4350
Country 122946 0
Australia
Phone 122946 0
+61 7 4631 2845
Fax 122946 0
Email 122946 0
prajwal.gyawali@usq.edu.au
Contact person for public queries
Name 122947 0
Dr Prajwal Gyawali
Address 122947 0
University of Southern Queensland
487-535 West Street
Toowoomba Qld 4350
Country 122947 0
Australia
Phone 122947 0
+61 7 4631 2845
Fax 122947 0
Email 122947 0
prajwal.gyawali@usq.edu.au
Contact person for scientific queries
Name 122948 0
Dr Prajwal Gyawali
Address 122948 0
University of Southern Queensland
487-535 West Street
Toowoomba Qld 4350
Country 122948 0
Australia
Phone 122948 0
+61 7 4631 2845
Fax 122948 0
Email 122948 0
prajwal.gyawali@usq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data underlying published results.
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 the primary sponsor.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
How or where can data be obtained?
Subject to approvals by Principal Investigator (tarynn.potter@usq.edu.au) or Principal Investigators Supervisor (prajwal.gyawali@usq.edu.au)


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.