Improving Follow up Care for People After Minor Stroke

Stroke, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05897905
• Other study ID #: 23CX8211
• Status: Recruiting
• Phase: N/A
• Start date: July 24, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: September 2023
• Source: Imperial College Healthcare NHS Trust
• Contact: Jennifer Crow
• Phone: 07795826663
• Email: jcrow[@]ic.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Qualitative interviews	Semi-structured	13 weeks
Primary	Recruitment rate	Proportion of participants randomised relative to the total number meeting the inclusion criteria.	Baseline
Primary	Treatment completion rate	Proportion of participants who attend both follow-up appointments	6 weeks post randomisation
Primary	Retention rate	Proportion of participants that complete the follow-up questionnaires	12 weeks post randomisation
Secondary	PROMIS10	Patient reported outcome measures information system	2 weeks and 12 weeks
Secondary	Health Care Climate Questionnaire Short Form	Patient reported outcome measure	Baseline and 12 weeks
Secondary	MOCA	Cognitive assessment	Baseline and 12 weeks
Secondary	PHQ9	Mood score	12 weeks
Secondary	GAD7	Anxiety score	12 weeks