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Improving Follow up Care for People After Minor Stroke

A Feasibility Study Investigating an Early, Personalised, Follow-up Programme for People After Minor Stroke

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05897905
Enrollment
60
Registered
2023-06-09
Start date
2023-07-24
Completion date
2024-08-31
Last updated
2023-09-29

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

Conditions

Stroke, Acute

Keywords

Secondary prevention, Adjustment to life after stroke, Hidden impairments, Cognition, Mood, Fatigue

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.

Interventions

BEHAVIORALPersonalised, 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.

Sponsors

Imperial College Healthcare NHS Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Retention rate12 weeks post randomisationProportion of participants that complete the follow-up questionnaires
Recruitment rateBaselineProportion of participants randomised relative to the total number meeting the inclusion criteria.
Treatment completion rate6 weeks post randomisationProportion of participants who attend both follow-up appointments

Secondary

MeasureTime frameDescription
MOCABaseline and 12 weeksCognitive assessment
GAD712 weeksAnxiety score
PHQ912 weeksMood score
PROMIS102 weeks and 12 weeksPatient reported outcome measures information system
Health Care Climate Questionnaire Short FormBaseline and 12 weeksPatient reported outcome measure

Other

MeasureTime frameDescription
Qualitative interviews13 weeksSemi-structured

Countries

United Kingdom

Contacts

Primary ContactJennifer Crow
jcrow@ic.ac.uk07795826663
Backup ContactParesh Malhotra
p.malhotra@imperial.ac.uk02033135525

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026