Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000962932
Ethics application status
Approved
Date submitted
20/07/2020
Date registered
25/09/2020
Date last updated
7/09/2021
Date data sharing statement initially provided
25/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Clot Retrieval Outcomes: Quality of life, emotions and thinking in people with stroke.
Scientific title
Evaluating post-stroke patient experiences following a clot retrieval procedure: Identifying unmet needs and ongoing concerns.
Secondary ID [1] 301826 0
none
Universal Trial Number (UTN)
Trial acronym
CROQUET
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 318306 0
clot retrieval 318307 0
Condition category
Condition code
Stroke 316318 316318 0 0
Ischaemic

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Up to 160 adults who receive clot retrieval for stroke will be contacted via letter and phone call at 2 months post-stroke and invited to participate. Patients must live in the Auckland metropolitan area (Auckland, Waitemata and Counties Manukau DHB catchments). Participants will complete a single session of assessments at 3 months post stroke. This session will take place in person at a location the patient chooses (their home, Auckland City Hospital, or another place of their choosing).

Participants will be asked to complete a study-specific questionnaire about their clot retrieval experience and any ongoing concerns about cognition, mood, or fatigue.

A subset of 40 participants will also be interviewed for more detailed responses. 20 participants who discharged directly home from the acute stroke service will be interviewed, and 20 who completed inpatient rehabilitation prior to discharge. Purposive sampling of patients who identify as Maori, Pasifika or Asian will be used. The interview will be audio recorded and transcribed for thematic analysis. Patients can choose to have a family member present and participating in the interview. Family members who choose to participate will provide written informed consent and are considered participants in the study. The interview is anticipated to take between 20 and 30 minutes.

After completing the questionnaire and interview (if appropriate), participants will complete clinical assessments of cognition (Addenbrookes Cognitive Evaluation III NZ version), fatigue (Fatigue Impact Scale), mood (Hospital Anxiety and Depression Scale), disability (modified Ranking Scale) and quality of life (Stroke Impact Scale).

The questionnaire, interview and clinical assessments will be completed by an experienced clinical assessor (occupational therapist or physiotherapist). This single session is anticipated to take 1.5 hours for most participants, and 2 hours for the subset who also complete the interview.
Intervention code [1] 318124 0
Not applicable
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324488 0
Themes emerging from patient experience questionnaires and interviews
Patient experiences will be assessed with a questionnaire and semi-structured interview. Themes assessed include: perception of issues with cognition, mood, and fatigue post-stroke; Whether these issues are affecting ability to return to work or usual activities; formal and informal support received post-stroke; perceptions and feelings related to the clot retrieval procedure; understanding of the clot-retrieval procedure.
Themes will be analysed from all participants with the questionnaire, and in more detail in a subset of 40 participants who complete the semi-structured interview.
Timepoint [1] 324488 0
3 months post-stroke
Primary outcome [2] 324910 0
Determining any unmet need including mood, cognition, fatigue or support for return to work/usual activities.
Participants will identify unmet need in response to specific questions in the questionnaire and semi-structured interview.
Unmet need data will be collected for all participants, with a subset of 40 participants providing more detailed responses through the semi-structured interview.
Timepoint [2] 324910 0
3 months post-stroke
Secondary outcome [1] 384792 0
Disability
Assessed with the modified Rankin Scale
Timepoint [1] 384792 0
3 months post-stroke
Secondary outcome [2] 386295 0
Quality of life and participation
Assessed with the Stroke Impact Scale. This scale is a composite measure of both quality of life and participation.
Timepoint [2] 386295 0
3 months post-stroke
Secondary outcome [3] 386296 0
Anxiety and Depression
Assessed with the Hospital Anxiety and Depression Scale. This scale is a composite measure of both anxiety and depression.
Timepoint [3] 386296 0
3 months post-stroke
Secondary outcome [4] 386297 0
Cognition
Assessed with the Addenbrookes Cognitive Examination III NZ version
Timepoint [4] 386297 0
3 months post-stroke
Secondary outcome [5] 386298 0
Fatigue
Assessed with the Fatigue Severity Scale
Timepoint [5] 386298 0
3 months post-stroke

Eligibility
Key inclusion criteria
Adults who had clot retrieval for stroke at Auckland City Hospital within last 2 months.
Live within the Auckland Metro area (Auckland, Waitemata and Counties Manukau District Health Boards)
Pre-stroke mRS (modified Rankin Scale) less than 3
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Discharged from the acute service directly to residential care facility
Severe communication or cognitive deficits preclude ability to provide informed consent
Life expectancy less than 6 months

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The estimated clot retrieval procedure numbers for Auckland metro region in 15 months is 200. Allowing for approximately 20% of eligible participants declining participation or being unavailable at 3 months post-stroke, the expected sample size is up to 160 patients.
No power calculation was conducted as this study is hypothesis generating.

Patient experience analyses:
Responses to questionnaire will be recorded on paper and coded for analysis. Responses to interviews will be audio recorded and then transcribed. Transcripts will be analysed by 2 investigatores using NVivo data analysis to identify themes. Thematic analysis will be completed with subgroups for ethnicity, age and whether the participant received inpatient rehabilitation or was discharged directly home from the acute service.

Participants will be asked if they have unmet needs in any of the following: fatigue, memory, concentration, problem solving, or mood. The percentage of patients reporting unmet need in each domain, and in more than 1 domain, will be calculated.

Clinical data analysis:
Standardised cut-off scores for clinical measures of cognition, mood, fatigue, quality of life and participation will be used to identify patients with deficits in these areas. The percentage of patients with deficits in each domain, and in more than 1 domain, will be calculated and reported. This data will be compared with the percentage of patients reporting unmet need.

Separate binary logistic regression analyses will be completed to identify potential clinical (stroke type, stroke severity) or demographic (age, sex, ethnicity) factors related to impairments in each domain (cognition, mood, fatigue, quality of life).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2020
Actual
15/10/2020
Date of last participant enrolment
Anticipated
29/10/2021
Actual
Date of last data collection
Anticipated
29/10/2021
Actual
Sample size
Target
160
Accrual to date
36
Final
Recruitment outside Australia
Country [1] 22774 0
New Zealand
State/province [1] 22774 0
Auckland

Funding & Sponsors
Funding source category [1] 306253 0
Charities/Societies/Foundations
Name [1] 306253 0
Auckland District Health Board Charitable Trust (A+ Trust)
Country [1] 306253 0
New Zealand
Primary sponsor type
Hospital
Name
Auckland District Health Board
Address
A+ Trust, Auckland District Health Board
Research Office
PO Box 92024
Grafton
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 306738 0
None
Name [1] 306738 0
Address [1] 306738 0
Country [1] 306738 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306462 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 306462 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 306462 0
New Zealand
Date submitted for ethics approval [1] 306462 0
Approval date [1] 306462 0
07/07/2020
Ethics approval number [1] 306462 0

Summary
Brief summary
A new treatment for patients with acute stroke has recently been established at Auckland District Health Board and is increasingly being used nationwide. Clot retrieval involves removing the clot using either suction aspiration or a stent. Successful clot retrieval allows the return of blood flow to the stroke-affected areas of the brain and results in significantly better outcomes for just over half of people treated.

While the benefits of clot retrieval for physical outcomes after stroke have been established, it is not clear whether patients continue to experience difficulties with their memory and thinking, fatigue or mood. Even mild issues in these areas present barriers to the person with stroke returning to work and their usual activities.

The purpose of this study is to identify any unmet cognitive or psychological needs in patients after clot retrieval and to find out whether these issues are affecting their return to work or their usual activities.

Up to 160 patients who live in the Auckland metro region and have clot retrieval at Auckland City Hospital will be invited to take part. At 3 months after stroke, patients will complete questionnaires and undergo clinical assessments to help us understand their experience of clot retrieval and identify any ongoing issues with cognition, mood and fatigue. Up to 40 people will also be invited to take part in a more detailed interview about their experiences. Establishing the level of need in this unique patient group will help District Health Boards nationwide tailor community rehabilitation services to support patients who have this new and important stroke treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103970 0
Dr Marie-Claire Smith
Address 103970 0
Department of Medicine
University of Auckland
Building 507
Level 2
28 Park Ave
Grafton
Auckland 1023
Country 103970 0
New Zealand
Phone 103970 0
+642102323351
Fax 103970 0
Email 103970 0
[email protected]
Contact person for public queries
Name 103971 0
Dr Marie-Claire Smith
Address 103971 0
Department of Medicine
University of Auckland
Building 507
Level 2
28 Park Ave
Grafton
Auckland 1023
Country 103971 0
New Zealand
Phone 103971 0
+642102323351
Fax 103971 0
Email 103971 0
[email protected]
Contact person for scientific queries
Name 103972 0
Dr Marie-Claire Smith
Address 103972 0
Department of Medicine
University of Auckland
Building 507
Level 2
28 Park Ave
Grafton
Auckland 1023
Country 103972 0
New Zealand
Phone 103972 0
+642102323351
Fax 103972 0
Email 103972 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.