Improving Follow up Care for People After Minor Stroke

Sponsor

Imperial College Healthcare NHS Trust (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05897905

Collaborator

(none)

Enrollment

Arms

14.6

Anticipated Duration (Months)

Study Details

Study Description

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:

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke, Acute	Behavioral: Personalised, holistic follow-up appointments underpinned by self determination theory	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Jun 15, 2023

Anticipated Primary Completion Date :

May 31, 2024

Anticipated Study Completion Date :

Aug 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard care All participants will receive a brief routine stroke medical follow-up appointment.
Experimental: Personalised, holistic based follow-up appointments underpinned by self determination theory. 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 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.

Arm

Intervention/Treatment

No Intervention: Standard care

All participants will receive a brief routine stroke medical follow-up appointment.

Experimental: Personalised, holistic based follow-up appointments underpinned by self determination theory.

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

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.

Outcome Measures

Primary Outcome Measures

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

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

Other Outcome Measures

Qualitative interviews [13 weeks]
Semi-structured

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.