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Improving Follow up Care for People After Minor Stroke

Primary Purpose

Stroke, Acute

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Personalised, holistic follow-up appointments underpinned by self determination theory
Sponsored by
Imperial College Healthcare NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stroke, Acute focused on measuring Secondary prevention, Adjustment to life after stroke, Hidden impairments, Cognition, Mood, Fatigue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Imperial College Healthcare NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard care

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

Arm Description

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

Participants will receive two follow-up appointments at two and six weeks after discharge.

Outcomes

Primary Outcome Measures

Recruitment rate
Proportion of participants randomised relative to the total number meeting the inclusion criteria.
Treatment completion rate
Proportion of participants who attend both follow-up appointments
Retention rate
Proportion of participants that complete the follow-up questionnaires

Secondary Outcome Measures

PROMIS10
Patient reported outcome measures information system
Health Care Climate Questionnaire Short Form
Patient reported outcome measure
MOCA
Cognitive assessment
PHQ9
Mood score
GAD7
Anxiety score

Full Information

First Posted
May 22, 2023
Last Updated
September 27, 2023
Sponsor
Imperial College Healthcare NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05897905
Brief Title
Improving Follow up Care for People After Minor Stroke
Official Title
A Feasibility Study Investigating an Early, Personalised, Follow-up Programme for People After Minor Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 24, 2023 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College Healthcare NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute
Keywords
Secondary prevention, Adjustment to life after stroke, Hidden impairments, Cognition, Mood, Fatigue

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard care
Arm Type
No Intervention
Arm Description
All participants will receive a brief routine stroke medical follow-up appointment.
Arm Title
Personalised, holistic based follow-up appointments underpinned by self determination theory.
Arm Type
Experimental
Arm Description
Participants will receive two follow-up appointments at two and six weeks after discharge.
Intervention Type
Behavioral
Intervention Name(s)
Personalised, holistic follow-up appointments underpinned by self determination theory
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment rate
Description
Proportion of participants randomised relative to the total number meeting the inclusion criteria.
Time Frame
Baseline
Title
Treatment completion rate
Description
Proportion of participants who attend both follow-up appointments
Time Frame
6 weeks post randomisation
Title
Retention rate
Description
Proportion of participants that complete the follow-up questionnaires
Time Frame
12 weeks post randomisation
Secondary Outcome Measure Information:
Title
PROMIS10
Description
Patient reported outcome measures information system
Time Frame
2 weeks and 12 weeks
Title
Health Care Climate Questionnaire Short Form
Description
Patient reported outcome measure
Time Frame
Baseline and 12 weeks
Title
MOCA
Description
Cognitive assessment
Time Frame
Baseline and 12 weeks
Title
PHQ9
Description
Mood score
Time Frame
12 weeks
Title
GAD7
Description
Anxiety score
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Qualitative interviews
Description
Semi-structured
Time Frame
13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 0-3. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Crow
Phone
07795826663
Email
jcrow@ic.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Paresh Malhotra
Phone
02033135525
Email
p.malhotra@imperial.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Crow
Organizational Affiliation
Imperial College Healthcare NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imperial College Healthcare NHS Trust
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Imperial CHN Trust

12. IPD Sharing Statement

Plan to Share IPD
No

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Improving Follow up Care for People After Minor Stroke

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