Stroke Circulatory System
Conditions
Interventions
This feasibility will be conducted in the West Midlands and recruit 60 participants, 30 will be randomised to the intervention (nurse/ therapist follow-up appointment) and 30 will be randomised to the
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults (aged >=18 years) 2. Resident in the West Midlands (county) 3. Ability to converse in everyday English and read in English 4. Capacity to provide fully informed consent for participation in the trial 5. Diagnosis of confirmed TIA or minor stroke by a stroke consultant. TIA will be defined as a transient episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction. Minor stroke will be defined as a modified Rankin scale score <=1 or no change in modified Rankin scale score from pre-event (to account for people who were disabled prior to their TIA/ minor stroke) 6. Attending the TIA clinic/ stroke ward for a new diagnosis of TIA/ minor stroke, rather than for a follow-up appointment
Exclusion criteria
Exclusion criteria: 1. History of full stroke 2. History of dementia 3. People who lack capacity to participate, such as if they have severe memory problems that mean they would not remember giving consent or if they have severe communication problems not precluding patients who use electronic devices to communicate 4. Patients receiving early supported discharge or cardiac rehabilitation 5. Patients receiving any palliative care
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility outcomes: 1. Number of eligible/ineligible patients and reasons for ineligibility measured using a recruitment log at baseline 2. Proportion of participants who consent face-to-face or postal measured using recorded method of consent at baseline 3. Willingness of clinical staff to randomise patients measured using qualitative interviews at 26 weeks 4. Recruitment and attrition rates measured using the recruitment log and questionnaire response rate at baseline, 1, 12 and 24 weeks 5. Response rates and frequencies of missing data: participant completed questionnaires and case report forms measured at 1, 12 and 24 weeks 6. End of study clinic appointment attendance rates measured using the clinic appointment CRF at 24 weeks 7. Acceptability of the trial design (patients and clinical staff) measured using qualitative interviews at 26 weeks 8. Standard deviations of continuous PROMs (HADS, FAS, EQ-5D, PROMIS-10, PAM-13, MARS 5) at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Process evaluation outcomes: 1. Participants’ and clinical staff’s opinion on acceptability of the intervention measured using qualitative interviews at 26 weeks 2. Intervention providers’ understanding of the intervention components measured using qualitative interviews at 26 weeks 3. Participants’ satisfaction with identification and management of needs measured using qualitative interviews at 26 weeks 4. Participants acting on agreed action plans and/or accessing support services measured using qualitative interviews at 26 weeks 5. Intervention providers’ understanding of the intervention components measured using qualitative interviews at 26 weeks 6. Intervention providers’ adherence to and deviations from the intervention manual measured using structured observations at 4 weeks 7. Control group contamination measured using qualitative interviews at 26 weeks 8. Intervention follow-up appointment: attendance, length of appointment and number of appointments measured using the intervention log at 4 weeks 9. Participants’ perception of the intervention measured using qualitative interviews at 26 weeks 10. Participants acting on agreed action plans and/or accessing support services measured using qualitative interviews at 26 weeks | — |
Countries
England, United Kingdom
Outcome results
None listed