NCT00129987

Brief Summary

Long term conditions often necessitate long term care. In many cases, giving control of their conditions to the patients themselves produces the best outcomes. Such patient education and the acquisition of self-management skills can be time consuming and the evidence suggests that the process is often not undertaken by doctors. Sometimes it is delegated to nursing colleagues, but all health professionals are in short supply. Patients carry credibility as a resource and this project is designed to determine, by means of a multi-centre randomised controlled trial, whether well trained lay educators can deliver training in self-management education to others with asthma, with outcomes equivalent to those achievable by a nurse.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
567

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Nov 2003

Typical duration for not_applicable 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

Study Start

First participant enrolled

November 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
13.5 years until next milestone

Results Posted

Study results publicly available

January 29, 2020

Completed
Last Updated

January 29, 2020

Status Verified

January 1, 2020

Enrollment Period

2.7 years

First QC Date

August 11, 2005

Results QC Date

January 8, 2020

Last Update Submit

January 17, 2020

Conditions

Keywords

Asthma

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Unscheduled Use of Healthcare

    Healthcare consists of one or other of hospital admission, emergency department attendance, unscheduled consultation with a GP

    1 year

Secondary Outcomes (3)

  • Lung Function

    1 year

  • Quality of Life Questionnaires

    1 year

  • Number of Participants With Use of Asthma Medication

    1 year

Study Arms (2)

Nurse group

EXPERIMENTAL

An initial consultation of up to 45 min offered either by a practice based primary care nurse, followed by a second shorter face to face consultation and telephone follow-up for 1 year.

Behavioral: Self management education

Lay educator group

EXPERIMENTAL

An initial consultation of up to 45 min offered either by a lay educator, followed by a second shorter face to face consultation and telephone follow-up for 1 year.

Behavioral: Self management education

Interventions

Lay educator groupNurse group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults step two therapy (BTS)
  • Evidence of poorly controlled disease

You may not qualify if:

  • Unable to benefit from self management education
  • Other respiratory conditions other than asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NHLI at Charing Cross Hospital Campus

London, W6 8RF, United Kingdom

Location

Related Publications (47)

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MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Martyn R Patridge
Organization
Imperial College London

Study Officials

  • Martyn R Partridge, MD FRCP

    NHLI Imperial College

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2005

First Posted

August 12, 2005

Study Start

November 1, 2003

Primary Completion

July 1, 2006

Study Completion

August 1, 2006

Last Updated

January 29, 2020

Results First Posted

January 29, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations