NCT00493090

Brief Summary

This study will address the key question of developing shared understanding and negotiating mutually acceptable outcomes between people with asthma and healthcare professionals by applying theoretical knowledge of self regulation and communication skills learning and practice to asthma consultations. This study will facilitate integration of best practice into normal care using the BTS/SIGN asthma guidelines as the basis for structured care. This intervention has been show to be effective in the US. We aim to show that it can be effective in the UK setting in a cluster randomised control trial. We aim to modify and evaluate the intervention in such a way that it can be easily offered across UK primary care settings, with the possibility of significant benefits for patients. The intervention is based on the principle of empowering patients to manage their condition themselves, is consistent with the aims of Asthma UK, and, for this reason, we believe that Asthma UK may wish to be associated with this project.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
360

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Oct 2005

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

January 21, 2016

Status Verified

November 1, 2015

Enrollment Period

2.8 years

First QC Date

June 26, 2007

Last Update Submit

January 20, 2016

Conditions

Keywords

Professionalpatient partnershippatient satisfactionprofessional training

Outcome Measures

Primary Outcomes (1)

  • The Juniper Mini Asthma Quality of Life Questionnaire (Mini AQLQ) (2) and the Medical Interview Satisfaction Scale (MISS-21).

    1 year

Secondary Outcomes (1)

  • The Patients' Perception of their Involvement Questionnaire (PPIQ) (4) and the Asthma Control Questionnaire (ACQ) (5).

    1 year

Interventions

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Practice:
  • Registered with SPPIRe
  • List size \> 5000
  • An asthma register
  • Electronic records
  • At least 1 GP and 1 Practice nurse commit to training
  • Commitment to ensuring questionnaire data is collected from 40 patients with poorly controlled asthma seen by either the GP or nurse
  • Patients:
  • Must be registered with recruited practices
  • Asthma diagnosis in excess of 12 months receiving regular preventative asthma therapy
  • Using in excess of twelve beta2 agonists during a twelve month period and/or experiencing an acute exacerbation of asthma requiring oral steroids in the last 12 months

You may not qualify if:

  • Practices:
  • Not registered with SPIRRe
  • Not wishing to take part.
  • Patients:
  • If they have well controlled asthma and do not experience any poor control.
  • Patients with physician-diagnosed predominantly irreversible airways disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Aberdeen

Aberdeen, AB25 2AY, United Kingdom

Location

MeSH Terms

Conditions

AsthmaPatient Satisfaction

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Jennifer Cleland

    University of Aberdeen

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 26, 2007

First Posted

June 27, 2007

Study Start

October 1, 2005

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

January 21, 2016

Record last verified: 2015-11

Locations