NCT00214669

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
375

participants targeted

Target at P75+ for phase_1 asthma

Timeline
Completed

Started Nov 2005

Longer than P75 for phase_1 asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

November 5, 2024

Status Verified

November 1, 2024

Enrollment Period

2.4 years

First QC Date

September 14, 2005

Last Update Submit

November 4, 2024

Conditions

Keywords

ethnicityprimary careeducation

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    12 months following recruitment date

Study Arms (2)

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.

Behavioral: PACE (Professional Asthma Care Education)Behavioral: Lay Led Expert Patient ProgrammeBehavioral: Asthma self management education by a specialist nurse

2

NO INTERVENTION

Usual Care

Interventions

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.

1

Lay-led 'expert-patient' education in small groups for patients, using an adaptation of Stanford University's chronic disease self-management programme.

Also known as: Expert Patient Programme
1

asthma education and self management, asthma action plans

1

Eligibility Criteria

Age3 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

London, E1 4NS, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Chris Griffiths, MB BS, DPhil

    Queen Mary's School of medicine and Dentistry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 22, 2005

Study Start

November 1, 2005

Primary Completion

April 1, 2008

Study Completion

April 1, 2009

Last Updated

November 5, 2024

Record last verified: 2024-11

Locations