Can Education for South Asians With Asthma and Their Clinicians Reduce Unscheduled Care? A Randomised Trial

NCT ID: NCT00214669

Last Updated: 2024-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

375 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2009-04-30

Brief Summary

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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:

1. provides self-management advice and a treatment plan,
2. makes a follow-up appointment in primary care
3. 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

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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:

1. provides self-management advice and a treatment plan,
2. makes a follow-up appointment for the patient in primary care
3. 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

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

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.

Group Type EXPERIMENTAL

PACE (Professional Asthma Care Education)

Intervention Type BEHAVIORAL

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 Programme

Intervention Type BEHAVIORAL

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 nurse

Intervention Type BEHAVIORAL

asthma education and self management, asthma action plans

2

Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Lay Led 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.

Intervention Type BEHAVIORAL

Asthma self management education by a specialist nurse

asthma education and self management, asthma action plans

Intervention Type BEHAVIORAL

Other Intervention Names

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Expert Patient Programme

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

3 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asthma UK

OTHER

Sponsor Role collaborator

Social Action for Health

UNKNOWN

Sponsor Role collaborator

Department of Health (Service Support - host acute/community)

UNKNOWN

Sponsor Role collaborator

Noreen Clarke, Professor of Public Health, Michigan University

OTHER

Sponsor Role collaborator

Barts & The London NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chris Griffiths, MB BS, DPhil

Role: PRINCIPAL_INVESTIGATOR

Queen Mary's School of medicine and Dentistry

Locations

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Barts and TheLondon, Queen Marys's School of Medicine and Dentistry

London, , United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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http://www.ichs.qmul.ac.uk

Institute of Health Sciences, place of work of principal investigator

Other Identifiers

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04/060

Identifier Type: -

Identifier Source: secondary_id

CG-09-05-IHS

Identifier Type: -

Identifier Source: org_study_id

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