Projects per year
Abstract
Introduction: People who experience transient ischaemic attack (TIA) and minor stroke have limited follow-up despite rapid specialist review in hospital. This means they often have unmet needs and feel abandoned following discharge. Care needs after TIA/minor stroke include information provision (diagnosis and stroke risk), stroke prevention (medication and lifestyle change) and holistic care (residual problems and return to work or usual activities). This protocol describes a feasibility study and process evaluation of an intervention to support people after TIA/minor stroke. The study aims to assess the feasibility and acceptability of (1) the intervention and (2) the trial procedures for a future randomised controlled trial of this intervention.
Methods and analysis: This is a multicentre, randomised (1:1) feasibility study with a mixed-methods process evaluation. Sixty participants will be recruited from TIA clinics or stroke wards at three hospital sites (England). Intervention arm participants will be offered a nurse or allied health professional-led follow-up appointment 4 weeks after TIA/minor stroke. The multifaceted intervention includes: a needs checklist, action plan, resources to support management of needs, a general practitioner letter and training to deliver the intervention. Control arm participants will receive usual care. Follow-up will be self-completed questionnaires (12 weeks and 24 weeks) and a clinic appointment (24 weeks). Follow-up questionnaires will measure anxiety, depression, fatigue, health related quality of life, self-efficacy and medication adherence. The clinic appointment will collect body mass index, blood pressure, cholesterol and medication. Assessment of feasibility and acceptability will include quantitative process variables (such as recruitment and questionnaire response rates), structured observations of study processes, and interviews with a subsample of participants and clinical staff.
Ethics and dissemination: Favourable ethical opinion was gained from the Wales Research Ethics Committee (REC) 1 (23 February 2021, REC reference: 21/WA/0036). Study results will be published in peer-reviewed journals and presented at conferences. A lay summary and dissemination strategy will be codesigned with consumers. The lay summary and journal publication will be distributed on social media.
Trial registration number: ISRCTN39864003.
Methods and analysis: This is a multicentre, randomised (1:1) feasibility study with a mixed-methods process evaluation. Sixty participants will be recruited from TIA clinics or stroke wards at three hospital sites (England). Intervention arm participants will be offered a nurse or allied health professional-led follow-up appointment 4 weeks after TIA/minor stroke. The multifaceted intervention includes: a needs checklist, action plan, resources to support management of needs, a general practitioner letter and training to deliver the intervention. Control arm participants will receive usual care. Follow-up will be self-completed questionnaires (12 weeks and 24 weeks) and a clinic appointment (24 weeks). Follow-up questionnaires will measure anxiety, depression, fatigue, health related quality of life, self-efficacy and medication adherence. The clinic appointment will collect body mass index, blood pressure, cholesterol and medication. Assessment of feasibility and acceptability will include quantitative process variables (such as recruitment and questionnaire response rates), structured observations of study processes, and interviews with a subsample of participants and clinical staff.
Ethics and dissemination: Favourable ethical opinion was gained from the Wales Research Ethics Committee (REC) 1 (23 February 2021, REC reference: 21/WA/0036). Study results will be published in peer-reviewed journals and presented at conferences. A lay summary and dissemination strategy will be codesigned with consumers. The lay summary and journal publication will be distributed on social media.
Trial registration number: ISRCTN39864003.
Original language | English |
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Article number | e060280 |
Number of pages | 10 |
Journal | BMJ open |
Volume | 12 |
Issue number | 6 |
DOIs | |
Publication status | Published - 16 Jun 2022 |
Bibliographical note
Funding Information:Competing interests MC and JM are National Institute for Health Research (NIHR) Senior Investigators. MC also receives funding from the National Institute for Health Research (NIHR), UK Research and Innovation (UKRI), the NIHR Birmingham Biomedical Research Centre, NIHR Surgical Reconstruction and Microbiology Research Centre and NIHR ARC West Midlands at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, UK SPINR (UKRI) Health Data Research UK, Innovate UK (part of UKRI), Macmillan Cancer Support, UCB Pharma, GSK, Gilead and Janssen. MC has received personal fees from Astellas, Aparito, CIA Oncology, Takeda, Merck, Daiichi Sankyo, Glaukos, GSK and the Patient-Centered Outcomes Research Institute (PCORI) outside the submitted work. JM has done consultancy work for BMS/Pfizer, Omron and Doctorlink Innovations.
Publisher Copyright:
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.
Keywords
- depression & mood disorders
- organisation of health services
- protocols & guidelines
- qualitative research
- rehabilitation medicine
- stroke medicine
ASJC Scopus subject areas
- General Medicine
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SUPPORT TIA: Structured follow-up Pathway to improve management of residual impairments and patients' quality of life after transient ischaemic Attack and minor stroke: Intervention refinement and feasibility study. OPEN FOR DISSEMINATION ONLY
Turner, G. (Principal Investigator), Jones, L. (Co-Investigator), Mathers, J. (Co-Investigator), Marshall, T. (Co-Investigator) & Calvert, M. (Co-Investigator)
NIHR TRAINEES COORDINATING CENTRE
1/01/18 → 31/10/25
Project: Other Government Departments