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Organising Support for Carers of Stroke Survivors (OSCARSS): A Cluster Randomised Controlled Trial with embedded Process Evaluation

OSCARSS: a pragmatic cluster randomised controlled trial with embedded process evaluation exploring the clinical and cost effectiveness of an approach to needs assessment and support for carers of stroke survivors

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN58414120
Enrollment
400
Registered
2017-01-17
Start date
2017-01-16
Completion date
Unknown
Last updated
2023-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke Circulatory System Stroke

Interventions

Participating Stroke Association services across England, Wales and Northern Ireland form independent clusters (N=36) to be randomised to either intervention or control in a 1:1 allocation ratio. Rand
it is a carer-led, practitioner-facilitated framework for how individualised support should be provided. CSNAT-Stroke training and intervention covers: initial contact with carers
the use of a needs assessment tool
an assessment conversation
a shared action and review plan. Carers will receive support from Stroke Association as per cluster allocation and will be invited to enrol in OSCARSS after the first face-to-face sup

Sponsors

University of Manchester
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Clusters/Staff: OSCARSS involves Stroke Association services and staff within those services whom: 1. Offer at least one face to face contact with carers as part of their service; 2. Have capacity to participate in the research; 3. For whom it would be meaningful and useful to perform a holistic carer needs assessment (some services only deliver a specific type of support) 4. Are likely to have at least five new client referrals per month. 'Clients' include both stroke survivors (who are likely to have associated carers ) and carers directly; 5. Are considered ‘independent’ of other clusters. Some Stroke Association staff across several services work closely in terms of geography and shared client caseload. To reduce between-group contamination, these services will be aggregated to form one ‘cluster’ for OSCARSS. Carers of stroke survivors: 1. Referred to participating Stroke Association clusters (either research intervention or control, as per randomisation); 2. Able to communicate in English; 3. ‘Active’ in their caring role at the time of study entry i.e. the stroke survivor being cared-for is alive 4. Aged 18 years and over

Exclusion criteria

Exclusion criteria: Not meeting inclusion criteria

Design outcomes

Primary

MeasureTime frame
Caregiver Strain is measured by the Caregiver Strain subscale of the Family Appraisal of Caregiving Questionnaire (FACQ) at 3 months.

Secondary

MeasureTime frame
All of the following relate to the cluster randomised controlled trial component of OSCARSS and are completed by carer self-report collected through postal questionnaires: 1. Caregiver Strain is measured by the Caregiver Strain subscale of the FACQ 6 months 2. Carergiver burden is measured using the Caregiver distress subscale of FACQ at 3 and 6 months 3. Positive impact of caring is measured using the Positive caregiving appraisals subscale of FACQ at 3 and 6 months 4. Satisfaction with stroke services provided is measured using the Pound Carer Satisfaction with Stroke Services Scale at 3 and 6 months 5. Mood is measured by the Hospital Anxiety and Depression Scale (HADS) at 3 and 6 months 6. Health is measured by the EQ-5D 5L questionnaire at 3 and 6 months 7. Economic burden of caring (for Health Economics evaluation), is measured using an adapted Service Receipt Inventory completed by carers to record healthcare services used and time spent caring at 3 and 6 months

Countries

England, United Kingdom

Contacts

Public ContactEmma Patchwood (née Patchick)
emma.patchwood@manchester.ac.uk+44 161 275 3401

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 4, 2026