AsthmaPhase 1OEDIPUSNCT00214669
Can Education for South Asians With Asthma and Their Clinicians Reduce Unscheduled Care? A Randomised Trial
A Phase 1 study testing PACE (Professional Asthma Care Education), Lay Led Expert Patient Programme and Asthma self management education by a specialist nurse in people with Asthma, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
People from ethnic minority groups suffer worse ill-health from asthma than those from majority groups. No studies have reduced emergency care for people from minority groups. We have developed an education programme to address barriers to improved care for south Asian people with asthma. Read more about this study
- Who is it for?
- Ages 3 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- PACE (Professional Asthma Care Education), Lay Led Expert Patient Programme and Asthma self management education by a specialist nurse
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2005to Apr 2009
- Phase
- Phase 1
- 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 3 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Recent hospital attendance (A\&E, admitted) with uncontrolled asthma
- or recent out of hours (GP service) walk in centre attendance with uncontrolled asthma
- South Asian ancestry (Bangladeshi, Indian, Pakistani, Sri Lankan)
- registered with a GP in Newham or Tower Hamlets
Who cannot join
- patients not of South Asian origin
- aged under 3 years
- not currently registered with a local GP
- physician diagnosis of pure COPD
- patients unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Barts and TheLondon, Queen Marys's School of Medicine and Dentistry
London, E1 4NS
About this study
Official title: Can Education for South Asians With Asthma and Their Clinicians Reduce Unscheduled Care? A Cluster Randomised Trial
People from ethnic minority groups suffer worse ill-health from asthma than those from majority groups. No studies have reduced emergency care for people from minority groups. We have developed an education programme to address barriers to improved care for south Asian people with asthma. The study is set in Tower Hamlets and Newham - the UK's most deprived and ethnically diverse boroughs. We will invite all the local GP practices to take part, and using a computer programme, randomised them (like tossing a coin) into two groups - a group receiving usual care and a group receiving our educational programme. This comprises:
- Education for specialist nurse and GPs and practice nurses, using our adaptation of an American education course, designed to improve shared-decision making, goal-setting and patient-clinician partnership.
- Lay-led 'expert-patient' education in small groups for patients, using an adaptation of another American course.
- Improved follow-up in primary care through appointment-booking by the specialist nurse.We will invite south Asians aged 3-65 years with asthma after A\&E attendance or hospital admission to take part. Those registered with practices receiving the educational programme will see the trial specialist nurse in a nurse-run clinic, where the nurse:
Read more
- provides self-management advice and a treatment plan,
- makes a follow-up appointment in primary care
- makes an appointment for lay-led 'expert-patient' sessions.Patients registered with 'usual care' practices receive usual care.
We will decide if our education programme works by comparing the number of emergency visits to GPs and hospital between the two groups.
Read the detailed description
Health inequalities between ethnic minority and majority groups exist for all chronic diseases and are a government priority for action. For asthma, poorer outcomes for people from minority groups are a universal finding. No randomised trials have reduced emergency asthma care for ethnic minority groups.
We have developed an intervention to address barriers to improved asthma care for south Asian people with asthma. This cluster randomised controlled trial tests whether education for south Asians with asthma and their clinicians can reduce unscheduled care. The trial is set in Tower Hamlets and Newham - boroughs with UK's 1st and 3rd highest ethnic minority populations.
We will invite all 94 general practices in these boroughs to take part. Practices will be randomised with stratification to intervention and control groups. The intervention comprises:
- Education for intervention specialist nurse and GPs and practice nurses from intervention practices, using our adaptation of Clarke's self-regulation education programme, designed to improve shared-decision making, goal-setting and patient-clinician partnership.
- Lay-led 'expert-patient' education in small groups for patients, using an adaptation of Lorig's chronic disease self-management programme.
- Improved follow-up in primary care through appointment-booking by the specialist nurse.
We will recruit south Asians aged 3-65 years with asthma after A\&E attendance or hospital admission. Participants registered with intervention practices will see the trial specialist nurse in a nurse-run hospital clinic, where the nurse:
- provides self-management advice and a treatment plan,
- makes a follow-up appointment for the patient in primary care
- makes an appointment for lay-led 'expert-patient' sessions.
Participants registered with control practices receive usual care. Primary outcomes are time to first unscheduled contact with acute asthma, and proportion of participants with unscheduled care, assessed from patient records 12 months after recruitment. Secondary outcomes are generic (EQ5D) and disease specific quality of life (AQ20 and North of England scales), prescribing and costs. The trial is powered to detect a 20% reduction in patients attending with unscheduled care (80% power 5% significance). Outcomes will be gathered by blinded researchers. Analysis will be carried out blind to allocation. Cost-effectiveness will be assessed using standard incremental cost-effectiveness ratios.
- Conditions
- Asthma
- Being tested
- PACE (Professional Asthma Care Education), Lay Led Expert Patient Programme, Asthma self management education by a specialist nurse
- Keywords
- ethnicity, primary care, education
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PACE (Professional Asthma Care Education)Behavioural
Education for intervention specialist nurse and GPs and practice nurses from intervention practices, using our adaptation of Clarke's self-regulation education programme, designed to improve shared-decision making, goal-setting and patient-clinician partnership.
Lay Led Expert Patient ProgrammeBehavioural
Also called Expert Patient Programme
Lay-led 'expert-patient' education in small groups for patients, using an adaptation of Stanford University's chronic disease self-management programme.
Asthma self management education by a specialist nurseBehavioural
asthma education and self management, asthma action plans
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Education for intervention specialist nurse and GPs and practice nurses from intervention practices, using our adaptation of Clarke's self-regulation education programme, designed to improve shared-decision making, goal-setting and patient-clinician partnership.
Lay-led 'expert-patient' education in small groups for patients, using an adaptation of Lorig's chronic disease self-management programme.
Improved follow-up in primary care through appointment-booking by the specialist nurse. Receives: Behavioral: PACE (Professional Asthma Care Education); Behavioral: Lay Led Expert Patient Programme; Behavioral: Asthma self management education by a specialist nurse |
| 2 | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcomes are time to first unscheduled contact with acute asthma, and proportion of participants with unscheduled care, assessed from patient records 12 months after recruitment.
Measured: 12 months following recruitment date
Secondary outcomes (1)
Secondary outcomes are generic (EQ5D) and disease specific quality of life (AQ20 and North of England scales), prescribing and costs.
Measured: 12 months following recruitment date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startNov 2005
- Primary completionApr 2008
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Asthma UK, Social Action for Health, Department of Health (Service Support - host acute/community), Noreen Clarke, Professor of Public Health, Michigan University
- Responsible party
- Sponsor
- Investigators
- Chris Griffiths, MB BS, DPhil, Principal investigator, Queen Mary's School of medicine and Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00214669
- Sponsor's protocol ID
- CG-09-05-IHS
- Other IDs
- 04/060
- Acronym
- OEDIPUS
- Status last verified
- Nov 2024
- First submitted
- 14 Sep 2005
- Last updated
- 5 Nov 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Education for South Asians With Asthma and Their Clinicians Reduce Unscheduled Care? A Cluster Randomised Trial
- ClinicalTrials.gov ID
- NCT00214669
- Acronym / sponsor ID
- OEDIPUS / CG-09-05-IHS
- Conditions
- Asthma
- Keywords
- ethnicity, primary care, education
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Collaborators
- Asthma UK, Social Action for Health, Department of Health (Service Support - host acute/community), Noreen Clarke, Professor of Public Health, Michigan University
- Study start
- Nov 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 22 Sep 2005 (estimated)
- 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.
People from ethnic minority groups suffer worse ill-health from asthma than those from majority groups. No studies have reduced emergency care for people from minority groups. We have developed an education programme to address barriers to improved care for south Asian people with asthma. The study is set in Tower Hamlets and Newham - the UK's most deprived and ethnically diverse boroughs. We will invite all the local GP practices to take part, and using a computer programme, randomised them (like tossing a coin) into two groups - a group receiving usual care and a group receiving our educational programme. This comprises:
- Education for specialist nurse and GPs and practice nurses, using our adaptation of an American education course, designed to improve shared-decision making, goal-setting and patient-clinician partnership.
- Lay-led 'expert-patient' education in small groups for patients, using an adaptation of another American course.
- Improved follow-up in primary care through appointment-booking by the specialist nurse.We will invite south Asians aged 3-65 years with asthma after A\&E attendance or hospital admission to take part. Those registered with practices receiving the educational programme will see the trial specialist nurse in a nurse-run clinic, where the nurse:
- provides self-management advice and a treatment plan,
- makes a follow-up appointment in primary care
- makes an appointment for lay-led 'expert-patient' sessions.Patients registered with 'usual care' practices receive usual care.
We will decide if our education programme works by comparing the number of emergency visits to GPs and hospital between the two groups.
Detailed description
Health inequalities between ethnic minority and majority groups exist for all chronic diseases and are a government priority for action. For asthma, poorer outcomes for people from minority groups are a universal finding. No randomised trials have reduced emergency asthma care for ethnic minority groups.
We have developed an intervention to address barriers to improved asthma care for south Asian people with asthma. This cluster randomised controlled trial tests whether education for south Asians with asthma and their clinicians can reduce unscheduled care. The trial is set in Tower Hamlets and Newham - boroughs with UK's 1st and 3rd highest ethnic minority populations.
We will invite all 94 general practices in these boroughs to take part. Practices will be randomised with stratification to intervention and control groups. The intervention comprises:
- Education for intervention specialist nurse and GPs and practice nurses from intervention practices, using our adaptation of Clarke's self-regulation education programme, designed to improve shared-decision making, goal-setting and patient-clinician partnership.
- Lay-led 'expert-patient' education in small groups for patients, using an adaptation of Lorig's chronic disease self-management programme.
- Improved follow-up in primary care through appointment-booking by the specialist nurse.
We will recruit south Asians aged 3-65 years with asthma after A\&E attendance or hospital admission. Participants registered with intervention practices will see the trial specialist nurse in a nurse-run hospital clinic, where the nurse:
- provides self-management advice and a treatment plan,
- makes a follow-up appointment for the patient in primary care
- makes an appointment for lay-led 'expert-patient' sessions.
Participants registered with control practices receive usual care. Primary outcomes are time to first unscheduled contact with acute asthma, and proportion of participants with unscheduled care, assessed from patient records 12 months after recruitment. Secondary outcomes are generic (EQ5D) and disease specific quality of life (AQ20 and North of England scales), prescribing and costs. The trial is powered to detect a 20% reduction in patients attending with unscheduled care (80% power 5% significance). Outcomes will be gathered by blinded researchers. Analysis will be carried out blind to allocation. Cost-effectiveness will be assessed using standard incremental cost-effectiveness ratios.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: PACE (Professional Asthma Care Education), Behavioral: Lay Led Expert Patient Programme, Behavioral: Asthma self management education by a specialist nurseEducation for intervention specialist nurse and GPs and practice nurses from intervention practices, using our adaptation of Clarke's self-regulation education programme, designed to improve shared-decision making, goal-setting and patient-clinician partnership. Lay-led 'expert-patient' education in small groups for patients, using an adaptation of Lorig's chronic disease self-management programme. Improved follow-up in primary care through appointment-booking by the specialist nurse. |
| 2 | No intervention | –Usual Care |
Who may qualify
- Ages
- 3 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Recent hospital attendance (A\&E, admitted) with uncontrolled asthma
- or recent out of hours (GP service) walk in centre attendance with uncontrolled asthma
- South Asian ancestry (Bangladeshi, Indian, Pakistani, Sri Lankan)
- registered with a GP in Newham or Tower Hamlets
Key exclusion criteria (5 listed)
- patients not of South Asian origin
- aged under 3 years
- not currently registered with a local GP
- physician diagnosis of pure COPD
- patients unable to give informed consent
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 |
|---|---|---|
| PACE (Professional Asthma Care Education)Education for intervention specialist nurse and GPs and practice nurses from intervention practices, using our adaptation of Clarke's self-regulation education programme, designed to improve shared-decision making, goal-setting and patient-clinician partnership. | Behavioural | 1 |
| Lay Led Expert Patient ProgrammeAlso: Expert Patient ProgrammeLay-led 'expert-patient' education in small groups for patients, using an adaptation of Stanford University's chronic disease self-management programme. | Behavioural | 1 |
| Asthma self management education by a specialist nurseasthma education and self management, asthma action plans | Behavioural | 1 |
Primary outcome
Primary outcomes are time to first unscheduled contact with acute asthma, and proportion of participants with unscheduled care, assessed from patient records 12 months after recruitment.
Time frame: 12 months following recruitment date
1 secondary outcome
Secondary outcomes are generic (EQ5D) and disease specific quality of life (AQ20 and North of England scales), prescribing and costs.
Time frame: 12 months following recruitment date
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 5 Nov 2024.
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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.
Chris Griffiths, MB BS, DPhil principal investigator
Queen Mary's School of medicine and Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PACE (Professional Asthma Care Education), Lay Led Expert Patient Programme and Asthma self management education by a specialist nurse in people with Asthma, run by Barts & The London 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 4 inclusion and 5 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 5 Nov 2024. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Primary outcomes are time to first unscheduled contact with acute asthma, and proportion of participants with unscheduled care, assessed from patient records 12 months after recruitment. (time frame: 12 months following recruitment date). 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 5 Nov 2024.