Improving Follow up Care for People After Minor Stroke

Not Applicable

Recruiting

• Conditions: Stroke, Acute
• Interventions: Behavioral: Personalised, holistic follow-up appointments underpinned by self determination theory

• Registration Number: NCT05897905
• Lead Sponsor: Imperial College Healthcare NHS Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-22
• Study First Submitted QC: 2023-06-01
• Study First Posted: 2023-06-09
• Study Start: 2023-07-24
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-27
• Last Update Posted: 2023-09-29
• Primary Completion: 2024-05-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Personalised, holistic based follow-up appointments underpinned by self determination theory.	Personalised, holistic follow-up appointments underpinned by self determination theory	Participants will receive two follow-up appointments at two and six weeks after discharge.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Health Care Climate Questionnaire Short Form	Baseline and 12 weeks	Patient reported outcome measure
PROMIS10	2 weeks and 12 weeks	Patient reported outcome measures information system
MOCA	Baseline and 12 weeks	Cognitive assessment
PHQ9	12 weeks	Mood score
GAD7	12 weeks	Anxiety score

Trial Locations

Locations (1)

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom