Stroke, AcuteNCT05897905
Improving Follow up Care for People After Minor Stroke
A study testing Personalised, holistic follow-up appointments underpinned by self determination theory in people with Stroke, Acute, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- Personalised, holistic follow-up appointments underpinned by self determination theory
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Jul 2023to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College Healthcare NHS Trust
London
Imperial CHN Trust
About this study
Official title: 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:
- 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
- Being tested
- Personalised, holistic follow-up appointments underpinned by self determination theory
- Keywords
- Secondary prevention, Adjustment to life after stroke, Hidden impairments, Cognition, Mood, Fatigue
- Medical subject headings
- Stroke, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalised, holistic follow-up appointments underpinned by self determination theoryBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Personalised, holistic follow-up appointments underpinned by self determination theory |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Proportion of participants randomised relative to the total number meeting the inclusion criteria.
Measured: Baseline
Treatment completion rate
Proportion of participants who attend both follow-up appointments
Measured: 6 weeks post randomisation
Retention rate
Proportion of participants that complete the follow-up questionnaires
Measured: 12 weeks post randomisation
Secondary outcomes (5)
PROMIS10
Patient reported outcome measures information system
Measured: 2 weeks and 12 weeks
Health Care Climate Questionnaire Short Form
Patient reported outcome measure
Measured: Baseline and 12 weeks
MOCA
Cognitive assessment
Measured: Baseline and 12 weeks
PHQ9
Mood score
Measured: 12 weeks
GAD7
Anxiety score
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start24 Jul 2023
- Primary completion31 May 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Crow, Principal investigator, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897905
- Sponsor's protocol ID
- 23CX8211
- Status last verified
- Sep 2023
- First submitted
- 22 May 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study Investigating an Early, Personalised, Follow-up Programme for People After Minor Stroke
- ClinicalTrials.gov ID
- NCT05897905
- Acronym / sponsor ID
- 23CX8211
- Conditions
- Stroke, Acute
- Keywords
- Secondary prevention, Adjustment to life after stroke, Hidden impairments, Cognition, Mood, Fatigue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Personalised, holistic follow-up appointments underpinned by self determination theoryParticipants will receive two follow-up appointments at two and six weeks after discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalised, holistic follow-up appointments underpinned by self determination theoryAppointment 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. | Behavioural | Personalised, holistic based follow-up appointments underpinned by self determination theory. |
Primary outcome
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
5 secondary outcomes
PROMIS10
Time frame: 2 weeks and 12 weeks
Health Care Climate Questionnaire Short Form
Time frame: Baseline and 12 weeks
MOCA
Time frame: Baseline and 12 weeks
PHQ9
Time frame: 12 weeks
GAD7
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Crow principal investigator
Imperial College Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalised, holistic follow-up appointments underpinned by self determination theory in people with Stroke, Acute, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Crow (07795826663, jcrow@ic.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.