Improving Follow up Care for People After Minor Stroke

NCT ID: NCT05897905

Last Updated: 2023-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-24
• Study Completion Date: 2024-08-31

Brief Summary

The goal of this feasibility study is to ascertain if this follow-up programme of care can feasibly be implemented within a healthcare system with people after minor stroke.

The main feasibility questions are:

i) To establish recruitment uptake ii) To establish treatment adherence iii) To determine participant retention. Participants will be randomly allocated to the intervention and control group. Those in the intervention group will receive a follow-up telephone call at two weeks after discharge and a second follow-up appointment at six weeks after discharge. Outcome measures will be taken at twelve weeks after discharge.

Conditions

Stroke, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Standard care

All participants will receive a brief routine stroke medical follow-up appointment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Personalised, holistic based follow-up appointments underpinned by self determination theory.

Participants will receive two follow-up appointments at two and six weeks after discharge.

Group Type: EXPERIMENTAL

Personalised, holistic follow-up appointments underpinned by self determination theory

Intervention Type: BEHAVIORAL

Appointment 1 (two weeks after discharge):

• Address participants knowledge gaps as regards their stroke, medication and secondary prevention.
• Detailed biopsychosocial review.
• Understand participant priorities and jointly set goals.
• Agreeing onward referrals if needed.
• Written summary sent to GP with copy to participant.

Appointment 2 (six weeks):

• Review priorities identified in post stroke review checklist.
• Review goals and plans from first appointment.
• Address any new or persistent information gaps.
• Review hidden impairments that may be impacting on return to work, activities of daily living, relationships or general well-being.
• Agreeing onward referrals and action plan.
• Written summary and plan sent to GP.

Interventions

Personalised, holistic follow-up appointments underpinned by self determination theory

Appointment 1 (two weeks after discharge):

• Address participants knowledge gaps as regards their stroke, medication and secondary prevention.
• Detailed biopsychosocial review.
• Understand participant priorities and jointly set goals.
• Agreeing onward referrals if needed.
• Written summary sent to GP with copy to participant.

Appointment 2 (six weeks):

• Review priorities identified in post stroke review checklist.
• Review goals and plans from first appointment.
• Address any new or persistent information gaps.
• Review hidden impairments that may be impacting on return to work, activities of daily living, relationships or general well-being.
• Agreeing onward referrals and action plan.
• Written summary and plan sent to GP.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Adult ≥18
• Clinical or radiological diagnosis of minor stroke from a stroke consultant.
• Admitted to HASU or seen in rapid assessment/TIA clinic.
• Pre-admission mRS of 0-3 with no formal package of care prior to stroke.
• Discharge mRS of 0-3.
• No onward referral to community therapy team or for package of care.
• Has capacity to consent.

Exclusion Criteria

• Any serious co-morbidities that would impact a person's ability to participate in the follow-up appointments and outcome measurement.
• Insufficient English to engage in intervention and outcome measures and no family or friends to support with this.
• Not resident in England.
• Pregnant women.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imperial College Healthcare NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Crow

Role: PRINCIPAL_INVESTIGATOR

Imperial College Healthcare NHS Trust

Locations

Imperial College Healthcare NHS Trust

London, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Jennifer Crow

Role: CONTACT

jcrow@ic.ac.uk

07795826663

Paresh Malhotra

Role: CONTACT

p.malhotra@imperial.ac.uk

02033135525

Facility Contacts

Imperial CHN Trust

Role: primary

Other Identifiers

23CX8211

Identifier Type: -

Identifier Source: org_study_id