Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001060831
Ethics application status
Approved
Date submitted
1/07/2021
Date registered
11/08/2021
Date last updated
15/07/2022
Date data sharing statement initially provided
11/08/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Self-care programme for informal carers of stroke survivors
Scientific title
Strengths-based resilience intervention for informal carers of stroke survivors - a feasibility randomized controlled trial
Secondary ID [1] 304655 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Resilience 322605 0
psychological well-being 322606 0
Condition category
Condition code
Mental Health 320218 320218 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention programme is known by the name of Strengths-Based Resilience.The Strengths-Based Resilience program is designed to help develop resilience, defined as the ability to cope with adversity. The program invites participants to reflect actively on their experiences that demonstrate various aspects of resilience. By reflecting back on these experiences, and engaging in other exercises, participants learn skills and strategies to build resilience. The programme comprises of 6 skills based sessions focusing on topics like story of resilience, cognitive accuracy and flexibility, signature strengths, grudge and gratitude, savouring and empathy and positive relationships.
The programme is being delivered by the PhD student who is an experienced psychologist with five years of clinical experience in delivering interventions. The programme is co-facilitated by the community stroke advisor stroke foundaton of New Zealand (Otago branch). Co-facilitation was considered for the sustainability and usefulness of the programme in future by the Stroke Foundation NZ.
The programme will be delivered face to face in group format. Two groups will take place in Dunedin and one in Oamaru. Groups will comprise of maximum five people per group. The intervention will be delivered for six months from June to November 2021. 6 x 2 hour sessions once / month for 6 months.
The intervention will take place at the Community House Dunedin and Oamaru - New Zealand. session attendance checklists will be used to monitor adherence to the intervention.
Intervention code [1] 321006 0
Treatment: Other
Comparator / control treatment
Comparator / control treatment includes the standard care provided to family carers of stroke survivors by the Stroke Foundation of NZ. This included carer support groups organized on quarterly basis.
Control group
Active

Outcomes
Primary outcome [1] 328088 0
The primary outcomes are feasibility outcomes, including recruitment data, attrition rate, feasibility and acceptability, adverse events and suitability of outcome measures.
Feasibility outcomes will be assessed quantitatively using study records audit and sudy specific questionnaires such as Connor and Davidson Resilience Scale and Psychological General Wellbeing Scale.
An embedde qualitative study will obtain participant's views about the experiences of the intervention including acceptability and utility of the intervention, Atleast 10 participants in the experimental group will be interviewed.
Timepoint [1] 328088 0
4 weeks post intervention
Secondary outcome [1] 397579 0
Mean Resilience Score using Connor-Davidson Resilience Scale (CD-RISC) (Connor & Davidson, 2003)
Timepoint [1] 397579 0
Baseline and one week post intervention
Secondary outcome [2] 397580 0
Mean Psychological Well-being score assessed using Psychological General Well-being Index (PGWB-S) (Grossi et al., 2006).
Timepoint [2] 397580 0
Baseline and one week post intervention

Eligibility
Key inclusion criteria
Aged 18 years or over
Informal or un-paid carer of a person with a confirmed diagnosis of stroke at least six months before the study
Capacity to provide informed consent
Willing to attend a once per month 6-month duration programme
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Formal or paid carers
Carers of people other than stroke survivors

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
Sample size estimation: To test the feasibility of delivering the programme the aim is to recruit up to 30 carers (15 in each arm of the trial). The median sample size for UK feasibility trials has been reported at 36 (Billingham et al; 2013) which is broadly consistent with the planned target.
Statistical methods: Feasibility outcomes, including recruitment data, attrition rate, feasibility and acceptability, adverse events and suitability of outcome measures will be analysed via descriptive statistics. Qualitative semi structured interviews will be conducted with participants in experimental group to obtain feedback on all aspects of the study in addition to the intervention procedures, assessments, intervention delivery, and perceived outcomes. The interviews will be audio recorded using a digital recorder, transcribed, and analysed using a thematic analysis approach (following the procedure described by Braun and Clark, 2006).
Outcome measure data will be will be analysed using the SPSS. The analysis will
use descriptive statistics and CIs for the parameters we are estimating.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
12/05/2021
Date of last participant enrolment
Anticipated
Actual
25/05/2021
Date of last data collection
Anticipated
10/12/2021
Actual
30/11/2021
Sample size
Target
30
Accrual to date
Final
27
Recruitment outside Australia
Country [1] 23930 0
New Zealand
State/province [1] 23930 0
Otago

Funding & Sponsors
Funding source category [1] 309018 0
University
Name [1] 309018 0
University Of Otago - Dunedin campus
Country [1] 309018 0
New Zealand
Primary sponsor type
Individual
Name
Ayesha Qureshi
Address
School of Physiotherapy
University of Otago
325 Great King Street
Dunedin 9016
New Zealand
Country
New Zealand
Secondary sponsor category [1] 309957 0
Individual
Name [1] 309957 0
Prof. Leigh Hale
Address [1] 309957 0
School of Physiotherapy
University of Otago
325 Great King Street
North Dunedin
Dunedin 9016
Country [1] 309957 0
New Zealand
Secondary sponsor category [2] 309976 0
Individual
Name [2] 309976 0
A/P Nicola Swain
Address [2] 309976 0
School of Physiotherapy
University of Otago
325 Great King Street
North Dunedin
Dunedin 9016
Country [2] 309976 0
New Zealand
Secondary sponsor category [3] 309977 0
Individual
Name [3] 309977 0
Dr. Daniela Aldabe
Address [3] 309977 0
School of Physiotherapy
University of Otago
325 Great KIng Street
North Dunedin
Dunedin 9016
Country [3] 309977 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308902 0
Human Ethics Comittee University of Otago Dunedin campus
Ethics committee address [1] 308902 0
Ethics committee country [1] 308902 0
New Zealand
Date submitted for ethics approval [1] 308902 0
08/03/2021
Approval date [1] 308902 0
25/03/2021
Ethics approval number [1] 308902 0
21/018

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112282 0
Ms Ayesha Qureshi
Address 112282 0
Centre for Health, Activity, and Rehabilitation Research
School of Physiotherapy
University of Otago
325 Great King Street
North Dunedin
Dunedin 9016
Country 112282 0
New Zealand
Phone 112282 0
+642102993353
Fax 112282 0
Email 112282 0
[email protected]
Contact person for public queries
Name 112283 0
Ayesha Qureshi
Address 112283 0
Centre for Health, Activity, and Rehabilitation Research
School of Physiotherapy
University of Otago
325 Great King Street
North Dunedin
Dunedin 9016
Country 112283 0
New Zealand
Phone 112283 0
+642102993353
Fax 112283 0
Email 112283 0
[email protected]
Contact person for scientific queries
Name 112284 0
Ayesha Qureshi
Address 112284 0
Centre for Health, Activity, and Rehabilitation Research
School of Physiotherapy
University of Otago
325 Great King Street
North Dunedin
Dunedin 9016
Country 112284 0
New Zealand
Phone 112284 0
+642102993353
Fax 112284 0
Email 112284 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.