Improving Follow up Care for People After Minor Stroke

NCT05897905 | Unknown

• 1 other identifier: 23CX8211
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Acute

Keywords

Secondary prevention; Adjustment to life after stroke; Hidden impairments; Cognition; Mood; Fatigue

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• PROMIS10

  2 weeks and 12 weeks

• Health Care Climate Questionnaire Short Form

  Baseline and 12 weeks

• MOCA

  Baseline and 12 weeks

• PHQ9

  12 weeks

• GAD7

  12 weeks

Other Outcomes (1)

• Qualitative interviews

  13 weeks

Study Arms (2)

Standard care

NO INTERVENTION

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

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

EXPERIMENTAL

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

Interventions

Personalised, holistic follow-up appointments underpinned by self determination theory BEHAVIORAL

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead

Study Sites (1)

Imperial College Healthcare NHS Trust

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Stroke; Fatigue

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer Crow

  Imperial College Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Crow

CONTACT

07795826663; jcrow@ic.ac.uk

Paresh Malhotra

CONTACT

02033135525; p.malhotra@imperial.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: June 9, 2023
• Study Start: July 24, 2023
• Primary Completion: May 31, 2024
• Study Completion: August 31, 2024
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)