Improving Follow up Care for People After Minor Stroke

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke, Acute
• Intervention / Treatment: Behavioral: Personalised, holistic follow-up appointments underpinned by self determination theory

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Crow; Phone Number: 07795826663; Email: jcrow@ic.ac.uk
• Study Contact Backup: Name: Paresh Malhotra; Phone Number: 02033135525; Email: p.malhotra@imperial.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom
    • Recruiting
    • Imperial College Healthcare NHS Trust
    • Contact: Imperial CHN Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative interviews	Semi-structured	13 weeks

Collaborators and Investigators

• Sponsor: Imperial College Healthcare NHS Trust
• Investigators: Principal Investigator: Jennifer Crow, Imperial College Healthcare NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2023
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: May 22, 2023
• First Submitted That Met QC Criteria: June 1, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Fatigue; Cognition; Secondary prevention; Mood; Adjustment to life after stroke; Hidden impairments
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 23CX8211

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No