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AsthmaNCT00493090

Evaluating the Impact of GP and Practice Nurse Training in Self Regulations Skills on Patient Outcomes

A study testing modification of an interactive seminar in people with Asthma, run by University of Aberdeen at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Asthma
What is being tested?
modification of an interactive seminar
How many people
360 participants
Where
1 siteUnited Kingdom
Study dates
Oct 2005to Jul 2008
Phase
Interventional
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 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Practice:
  • Registered with SPPIRe
  • List size > 5000
  • An asthma register
  • Electronic records
  • At least 1 GP and 1 Practice nurse commit to training
Show all 11Show fewer
  • 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

Who cannot join

  • Practices:
  • Not registered with SPIRRe
  • Not reaching the inclusion criteria
  • 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • University of Aberdeen

    Aberdeen, AB25 2AY

Other trials in United Kingdom

About this study

Official title: Effects of Patient-centred Asthma Education for GPs and Practice Nurses:Evaluating the Impact of Training in Self Regulation Skills on Patient Outcomes:a Randomised Controlled Trial

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.

Read the detailed description

This study involves training GPs and nurses to recognize that patients differ in terms of asthma characteristics, such as symptoms and triggers, as well as personal attributes and lifestyles. The programme teaches professionals to work with patients to improve their asthma management; this involves helping people with asthma to observe themselves and their own actions, and learn from these, to support self-help behaviours, integrating these into their daily routines. The programme emphasizes good communication skills and working in partnership with patients, as well as up-dating doctors and nurses in current best practice for treating asthma. It is based on a programme successfully developed with American office based paediatricians, which resulted in greater parent satisfaction with asthma visits to doctors, and better asthma symptom control for patients. We wish to modify this American programme to make it more suitable for UK doctors, nurses and patients. We have also included a component into the programme to identify what exactly is effective in terms of how it impacts on clinician attitudes, beliefs and behaviour before delivering it more widely. The success of the project is evaluated not only by testing whether it improves the medical care and medical outcomes of patients of the health professionals taking part, but also by measuring whether patients are more satisfied with their consultations for asthma if their doctor or nurse has taken part in the programme. UK (http://www.sign.ac.uk/) evidence-based guidelines recommend helping those with asthma to control their symptoms and improve their quality of life through provision of education and individualised, written action plans. Our aim is to carry out a prospective, cluster randomised trial in general practices in Aberdeen and Glasgow, Scotland, to assess the impact of an educational intervention targeted at training practice nurses and general practitioners (GPs) in patient-centred asthma care; specifically in how to help patients develop asthma self regulation skills. The intervention is modified from a programme successfully implemented with American office based paediatricians, found to be effective in an US paediatric asthma population in terms of clinical outcomes and parent satisfaction (1).

The hypothesis is that patients seen by doctors and nurses in primary care who have been trained in developing patient self regulation skills will have better asthma-related quality of life, control and clinical outcomes, and be more satisfied with the clinical consultation, than a control group of patients attending doctors and nurses who have not received training.

One nominated GP and one nominated practice nurse from eight intervention practices will receive training modified from the Clark-Evans programme of asthma training. GPs and practice nurses nominated by eight control practices will deliver care as usual during the study.

Patients will be targeted for recruitment when they present with symptoms or signs relating to poorly controlled asthma to the nominated GPs or Practice nurses. Questionnaire data will be collected from a baseline cohort, until 20 datasets per practice (16) have accrued (320 in total). Questionnaire data will then be collected from 20 patients per practice presenting in the same circumstances to the nominated GPs and Practice nurses in the intervention practices (160 in total). Questionnaire data will also be collected from 20 patients per practice presenting in the same circumstances to the nominated GPs and Practice nurses in the control practices, who will deliver care as usual (160 in total). The post training cohorts (control and intervention) will have follow up questionnaires at 3 and 12 months after the index consultation. Routinely available data will be collected for all patients with evidence of poorly controlled asthma before and after training. A total of 320 patients (160 to each arm) from a total of 16 practices (ie. 20 patients per practice) will ensure 90% power in the baseline and post-intervention cohorts at the 5% significance level (randomisation is by practice so this sample size calculation was inflated to correct for the intracluster correlation coefficient (ICC)) .

The primary outcome measures will be the Mini AQLQ (2) and the Medical Interview Satisfaction Scale (MISS-21) (3). Secondary measures will be: Patients' Perception of their Involvement Questionnaire (4), the Asthma Control Questionnaire, (ACQ) (5). A theory of planned behaviour questionnaire will be used to examine how specific components of the training package influenced GP and practice nurse attitudes, behavioural intentions and self-efficacy. This will identify how and why the training worked, and inform further modifications of the programme to aid generalizability across UK settings.

Conditions
Asthma
Being tested
modification of an interactive seminar
Keywords
Professional, patient partnership, patient satisfaction, professional training
Medical subject headings
Asthma, Patient Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • modification of an interactive seminarBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 1 year

Secondary outcomes (1)
  1. The Patients' Perception of their Involvement Questionnaire (PPIQ) (4) and the Asthma Control Questionnaire (ACQ) (5).

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2007 (estimated)
  2. Study startOct 2005
  3. Primary completionJul 2008
  4. Study completionJul 2008

Resources

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 N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
360 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00493090
Sponsor's protocol ID
05/015
Status last verified
Nov 2015
First submitted
26 Jun 2007
Last updated
21 Jan 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing modification of an interactive seminar in people with Asthma, run by University of Aberdeen 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 11 inclusion and 7 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 21 Jan 2016. 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.

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?

The Juniper Mini Asthma Quality of Life Questionnaire (Mini AQLQ) (2) and the Medical Interview Satisfaction Scale (MISS-21). (time frame: 1 year). 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 21 Jan 2016.

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