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Clinical Trials/NCT05897905
NCT05897905
Recruiting
Not Applicable

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

Imperial College Healthcare NHS Trust1 site in 1 country60 target enrollmentJuly 24, 2023
ConditionsStroke, Acute

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke, Acute
Sponsor
Imperial College Healthcare NHS Trust
Enrollment
60
Locations
1
Primary Endpoint
Recruitment rate
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 24, 2023
End Date
August 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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-
  • 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.

Outcomes

Primary Outcomes

Recruitment rate

Time Frame: Baseline

Proportion of participants randomised relative to the total number meeting the inclusion criteria.

Treatment completion rate

Time Frame: 6 weeks post randomisation

Proportion of participants who attend both follow-up appointments

Retention rate

Time Frame: 12 weeks post randomisation

Proportion of participants that complete the follow-up questionnaires

Secondary Outcomes

  • Health Care Climate Questionnaire Short Form(Baseline and 12 weeks)
  • PROMIS10(2 weeks and 12 weeks)
  • MOCA(Baseline and 12 weeks)
  • PHQ9(12 weeks)
  • GAD7(12 weeks)

Study Sites (1)

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