StrokeIPCASNCT03353519
Improving Primary Care After Stroke (IPCAS)
A study testing Primary care model in people with Stroke, run by University of Cambridge at 2 sites in United Kingdom.
Trial summary
No formal primary care based model of care exists to support stroke survivors living in the community. A large variation in the range, quality and access to health services offered to stroke survivors between and within local clinical commissioning groups suggests that many of the stroke survivors' needs are not being… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Primary care model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,041 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 30 Apr 2018to 30 Sep 2020
- 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
- On practice register with a history of stroke.
- Able to provide written informed consent (with or without the help of a carer).
- Age 18 years or older.
Who cannot join
- Patients on the palliative care register.
- Patients living in a nursing home.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Improving Primary Care After Stroke (IPCAS): A Randomised Controlled Trial to Evaluate a New Model of Care for Stroke Survivors Living in the Community
No formal primary care based model of care exists to support stroke survivors living in the community. A large variation in the range, quality and access to health services offered to stroke survivors between and within local clinical commissioning groups suggests that many of the stroke survivors' needs are not being met systematically. Therefore, to address the longer term needs we have developed a multi-factorial primary care model that seeks to enable greater engagement with stroke care and community services, to link effectively to specialist services, and to improve the lives of stroke survivors.
This will be a two-arm cluster randomised controlled trial. Participating general practices will be randomised to deliver either the new model of stroke care or current usual care. The aim of this trial will be to assess the clinical and long-term cost effectiveness of the new model of primary care for stroke survivors living in the community. The primary outcome for the trial will be measured using two sub-scales (emotion and handicap) of the Stroke Impact Scale questionnaire at 12 months.
Read the detailed description
The IPCAS trial is a two-arm cluster randomised controlled trial with general practices as the unit of randomisation. The aim of this trial is to evaluate the clinical and long-term cost effectiveness of a novel model of primary care for stroke survivors living in the community.
People with a history of stroke on the registers of GP practices in the East of England and the East Midlands will be invited to take part. We will aim to recruit approximately 920 people registered with 46 general practices. We will target Practices with a stroke register comprising a minimum of 100 patients, to ensure that we reach our cluster target of 16 - 24 participants.
Potentially eligible participants will be sent an invitation to take part in the study by their GP surgery. Once all invitation letters and reminders have been sent out to patients in a practice, the GP practice will be randomised. GP practices will be randomised in a ratio of 1:1 to intervention or control. Intervention practices will deliver the new model of primary care. The control arm will consist of current usual care.
Data collection will occur at baseline and at 6 and 12 months. This will comprise a combination of postal and telephone administered questionnaires and a review of general practice notes. The primary endpoint for the trial will be two sub-scales (emotion and handicap) of the Stroke Impact Scale (SIS v3.0) as co-primary outcomes at 12 months (adjusted for baseline). Economic evaluation as well as quantitative and qualitative assessments of intervention fidelity will also be performed.
- Conditions
- Stroke
- Being tested
- Primary care model
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary care modelOther
Specifically, the intervention will comprise the following components:
- Structured review of patient needs;
- A self-management programme (MLAS) for stroke survivors and their carers;
- A direct point of contact for stroke survivors and carers at the GP surgery;
- Optimised communication between General Practice staff and specialist services;
- Service mapping for stroke related needs;
- Training for General Practice staff.
| Study group | Role | What they receive |
|---|---|---|
| Primary care model | Experimental | The new model of care incorporates a multi-factorial package of service aimed at providing a review of patient needs, facilitated self-management of longer-term stroke care needs for survivors and their carers, optimised communication between patients and health and social care services, optimised communication between the different care services, and increased awareness of and access to national and local community and charity provided services. Receives: Other: Primary care model |
| Usual care | No intervention | The control arm will consist of the usual care currently provided for stroke survivors registered with each general practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke Impact Scale (SIS v3.0)
The primary endpoint for the trial will be two sub-scales (emotion and handicap) of the Stroke Impact Scale as co-primary outcomes. The SIS is a 59-item mail administered stroke-specific health-related quality of life (HRQoL) measure. Each item is rated on a 5 point Likert scale with answers based on the level of difficulty.
Measured: 12 months after attendance at a review
Secondary outcomes (5)
Stroke Impact Scale Short Form (SIS-SF)
The SIS Short Form consists of 8 items comprising one question from each of the SIS domains (strength, hand function, mobility, activities of daily living, memory, communication, emotion and handicap). Each item is rated on a 5 point Likert scale with answers based on the level of difficulty.
Measured: 6 and 12 months after attendance at a review
EQ-5D-5L
The EQ-5D-5L is a standardised measure of health status suitable for health and economic appraisal. The responses to 5 dimensions can be combined to provide a 5 digit profile. The profile can be converted using a link function to a single index value which facilitates the calculation of quality-adjusted life years (QALYs). The questionnaire will be used to allow for economic evaluation.
Measured: 6 and 12 months after attendance at a review
ICEpop CAPability measure for Adults (ICECAP-A)
ICECAP-A is also used in economic evaluation. The ICECAP-A focuses on wellbeing defined in a broader sense rather than health. It comprises of 5 attributes: Attachment, Stability, Achievement, Enjoyment and Autonomy. Each attribute is judged on a 4-point Likert scale ranging from full capability to no capability.
Measured: 6 and 12 months after attendance at a review
Southampton Stroke Self-management Questionnaire (SSSQ)
SSSQ is a 28 item scale covering aspects of managing health and communication with health care professionals.
Measured: 12 months after attendance at a review
Health Literacy Questionnaire (HLQ)
The HLQ is a self-report measure of patients' strengths and limitations in their ability to access, understand and effectively use health information and services. It has 44 items covering the following 9 domains: (1) feeling understood and supported by healthcare providers; (2) having sufficient information to manage health; (3) actively managing health; (4) social support for health; (5) appraisal of health information; (6) ability to actively engage with healthcare providers; (7) navigating the healthcare system; (8) ability to find good health information; (9) understand health information.
Measured: 12 months after attendance at a review
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start30 Apr 2018
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The IPCAS Trial is a two-arm cluster randomised controlled trial with general practices as the unit of randomisation.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,041 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals, Leicester
- Responsible party
- Principal investigator, Professor Jonathan Mant, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353519
- Sponsor's protocol ID
- RG71908
- Acronym
- IPCAS
- Status last verified
- Apr 2021
- First submitted
- 10 Nov 2017
- Last updated
- 7 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aquino MRJ, Turner G, Kreit E, Blatchford EG, Grant J, Johnson V, Mullis R, Mant J. Implementing a new model of primary care for stroke survivors living in the community: a mixed-methods process evaluation. Trials. 2025 Jul 19;26(1):249. doi: 10.1186/s13063-025-08957-w.
PubMed 40684242Blatchford EG, Aquino MRJ, Grant J, Johnson V, Mullis R, Lim L, Mant J. Patients' experience of and participation in a stroke self-management programme, My Life After Stroke (MLAS): a multimethod study. BMJ Open. 2022 Nov 15;12(11):e062700. doi: 10.1136/bmjopen-2022-062700.
PubMed 36379661Aquino MRJR, Mullis R, Kreit E, Johnson V, Grant J, Lim L, Sutton S, Mant J. Improving Primary Care After Stroke (IPCAS) randomised controlled trial: protocol for a multidimensional process evaluation. BMJ Open. 2020 Jul 8;10(7):e036879. doi: 10.1136/bmjopen-2020-036879.
PubMed 32641334Mullis R, Aquino MRJR, Dawson SN, Johnson V, Jowett S, Kreit E, Mant J; IPCAS investigator team. Improving Primary Care After Stroke (IPCAS) trial: protocol of a randomised controlled trial to evaluate a novel model of care for stroke survivors living in the community. BMJ Open. 2019 Aug 18;9(8):e030285. doi: 10.1136/bmjopen-2019-030285.
PubMed 31427339
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Primary Care After Stroke (IPCAS): A Randomised Controlled Trial to Evaluate a New Model of Care for Stroke Survivors Living in the Community
- ClinicalTrials.gov ID
- NCT03353519
- Acronym / sponsor ID
- IPCAS / RG71908
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,041 participants (actual)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- University Hospitals, Leicester
- Study start
- 30 Apr 2018 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 27 Nov 2017 (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.
No formal primary care based model of care exists to support stroke survivors living in the community. A large variation in the range, quality and access to health services offered to stroke survivors between and within local clinical commissioning groups suggests that many of the stroke survivors' needs are not being met systematically. Therefore, to address the longer term needs we have developed a multi-factorial primary care model that seeks to enable greater engagement with stroke care and community services, to link effectively to specialist services, and to improve the lives of stroke survivors.
This will be a two-arm cluster randomised controlled trial. Participating general practices will be randomised to deliver either the new model of stroke care or current usual care. The aim of this trial will be to assess the clinical and long-term cost effectiveness of the new model of primary care for stroke survivors living in the community. The primary outcome for the trial will be measured using two sub-scales (emotion and handicap) of the Stroke Impact Scale questionnaire at 12 months.
Detailed description
The IPCAS trial is a two-arm cluster randomised controlled trial with general practices as the unit of randomisation. The aim of this trial is to evaluate the clinical and long-term cost effectiveness of a novel model of primary care for stroke survivors living in the community.
People with a history of stroke on the registers of GP practices in the East of England and the East Midlands will be invited to take part. We will aim to recruit approximately 920 people registered with 46 general practices. We will target Practices with a stroke register comprising a minimum of 100 patients, to ensure that we reach our cluster target of 16 - 24 participants.
Potentially eligible participants will be sent an invitation to take part in the study by their GP surgery. Once all invitation letters and reminders have been sent out to patients in a practice, the GP practice will be randomised. GP practices will be randomised in a ratio of 1:1 to intervention or control. Intervention practices will deliver the new model of primary care. The control arm will consist of current usual care.
Data collection will occur at baseline and at 6 and 12 months. This will comprise a combination of postal and telephone administered questionnaires and a review of general practice notes. The primary endpoint for the trial will be two sub-scales (emotion and handicap) of the Stroke Impact Scale (SIS v3.0) as co-primary outcomes at 12 months (adjusted for baseline). Economic evaluation as well as quantitative and qualitative assessments of intervention fidelity will also be performed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The IPCAS Trial is a two-arm cluster randomised controlled trial with general practices as the unit of randomisation.
| Arm | Type | Receives |
|---|---|---|
| Primary care model | Experimental | Other: Primary care modelThe new model of care incorporates a multi-factorial package of service aimed at providing a review of patient needs, facilitated self-management of longer-term stroke care needs for survivors and their carers, optimised communication between patients and health and social care services, optimised communication between the different care services, and increased awareness of and access to national and local community and charity provided services. |
| Usual care | No intervention | –The control arm will consist of the usual care currently provided for stroke survivors registered with each general practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- On practice register with a history of stroke.
- Able to provide written informed consent (with or without the help of a carer).
- Age 18 years or older.
Key exclusion criteria (2 listed)
- Patients on the palliative care register.
- Patients living in a nursing home.
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 |
|---|---|---|
| Primary care modelSpecifically, the intervention will comprise the following components: 1. Structured review of patient needs; 2. A self-management programme (MLAS) for stroke survivors and their carers; 3. A direct point of contact for stroke survivors and carers at the GP surgery; 4. Optimised communication between General Practice staff and specialist services; 5. Service mapping for stroke related needs; 6. Training for General Practice staff. | Other | Primary care model |
Primary outcome
Stroke Impact Scale (SIS v3.0)
Time frame: 12 months after attendance at a review
The primary endpoint for the trial will be two sub-scales (emotion and handicap) of the Stroke Impact Scale as co-primary outcomes. The SIS is a 59-item mail administered stroke-specific health-related quality of life (HRQoL) measure. Each item is rated on a 5 point Likert scale with answers based on the level of difficulty.
5 secondary outcomes
Stroke Impact Scale Short Form (SIS-SF)
Time frame: 6 and 12 months after attendance at a review
EQ-5D-5L
Time frame: 6 and 12 months after attendance at a review
ICEpop CAPability measure for Adults (ICECAP-A)
Time frame: 6 and 12 months after attendance at a review
Southampton Stroke Self-management Questionnaire (SSSQ)
Time frame: 12 months after attendance at a review
Health Literacy Questionnaire (HLQ)
Time frame: 12 months after attendance at a review
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2021.
- Derived from this study: PubMed 40684242Aquino MRJ, Turner G, Kreit E, Blatchford EG, Grant J, Johnson V, Mullis R, Mant J. Implementing a new model of primary care for stroke survivors living in the community: a mixed-methods process evaluation. Trials. 2025 Jul 19;26(1):249. doi: 10.1186/s13063-025-08957-w.
- Derived from this study: PubMed 36379661Blatchford EG, Aquino MRJ, Grant J, Johnson V, Mullis R, Lim L, Mant J. Patients' experience of and participation in a stroke self-management programme, My Life After Stroke (MLAS): a multimethod study. BMJ Open. 2022 Nov 15;12(11):e062700. doi: 10.1136/bmjopen-2022-062700.
- Derived from this study: PubMed 32641334Aquino MRJR, Mullis R, Kreit E, Johnson V, Grant J, Lim L, Sutton S, Mant J. Improving Primary Care After Stroke (IPCAS) randomised controlled trial: protocol for a multidimensional process evaluation. BMJ Open. 2020 Jul 8;10(7):e036879. doi: 10.1136/bmjopen-2020-036879.
- Derived from this study: PubMed 31427339Mullis R, Aquino MRJR, Dawson SN, Johnson V, Jowett S, Kreit E, Mant J; IPCAS investigator team. Improving Primary Care After Stroke (IPCAS) trial: protocol of a randomised controlled trial to evaluate a novel model of care for stroke survivors living in the community. BMJ Open. 2019 Aug 18;9(8):e030285. doi: 10.1136/bmjopen-2019-030285.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary care model in people with Stroke, run by University of Cambridge at 2 sites 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke Impact Scale (SIS v3.0) (time frame: 12 months after attendance at a review). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03353519, which also lists 4 linked publications.
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 7 Oct 2021.