Improving Follow up Care for People After Minor Stroke

Study Overview
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Brief Summary
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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.

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

Conditions
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Stroke, Acute

Intervention / Treatment
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* Behavioral: Personalised, holistic follow-up appointments underpinned by self determination theory


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard care<br>All participants will receive a brief routine stroke medical follow-up appointment. | |
| Experimental: Personalised, holistic based follow-up appointments underpinned by self determination theory.<br>Participants will receive two follow-up appointments at two and six weeks after discharge. | Behavioral: Personalised, holistic follow-up appointments underpinned by self determination theory<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate | Proportion of participants randomised relative to the total number meeting the inclusion criteria. | Baseline | 
| Treatment completion rate | Proportion of participants who attend both follow-up appointments | 6 weeks post randomisation | 
| Retention rate | Proportion of participants that complete the follow-up questionnaires | 12 weeks post randomisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS10 | Patient reported outcome measures information system | 2 weeks and 12 weeks | 
| Health Care Climate Questionnaire Short Form | Patient reported outcome measure | Baseline and 12 weeks | 
| MOCA | Cognitive assessment | Baseline and 12 weeks | 
| PHQ9 | Mood score | 12 weeks | 
| GAD7 | Anxiety score | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Secondary prevention, Adjustment to life after stroke, Hidden impairments, Cognition, Mood, Fatigue