- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00129662
Comprehension and Evaluation of a Pictorial Action Plan for Those With Asthma or COPD
Comprehension and Evaluation of a Pictorial Action Plan for Those With Asthma or Chronic Obstructive Pulmonary Disease
Some five million people in the United Kingdom (U.K.) have asthma. The British Guidelines on Asthma recommend self management education and the issuing of written personal asthma action plans. The use of such self management education has been shown to be associated with an up to 40% reduction in hospitalisation rates and a 20% reduction in Emergency Department attendances and similar benefits in terms of symptoms and time off work. In asthma, the results are best when the patients are provided with a personalised written action plan explaining how to alter their medications according to a variety of circumstances. Chronic obstructive pulmonary disease is a major cause of hospitalisation in the U.K. and is the fourth biggest single cause of death. A recent Cochrane review regarding the value of self management education in COPD has led to equivocal results although it has shown that those with COPD are willing to take control of their own conditions. The reasons for the different outcomes in asthma and COPD may reflect an inadequate number of trials of the wrong type; interventions that were not appropriate or do not work; lack of the use of written action plans; or assessment of benefit using the wrong outcomes.
Given the importance attached to the written action plan, it is essential that such advice is available to all. However, studies of outpatients attending hospitals in the U.K. have shown that 15% may be functionally illiterate and in studies of adults with asthma in the United States (U.S.), 13% have similarly shown to be functionally illiterate. Pictorial advice may therefore be advantageous and, when tested amongst those who are literate, it has been also shown to enhance the recall of spoken medical instructions. The investigators have therefore prepared some pictorial representations which are designed to give advice to those with asthma and COPD about how to recognise the worsening of their conditions and what treatments to alter or initiate as a result. The investigators now need to assess the comprehensibility of those materials amongst a selection of patients with asthma and COPD.
Study Overview
Detailed Description
Some five million people in the U.K have asthma. The British Guidelines on Asthma recommend self management education and the issuing of written personal asthma action plans. The use of such self management education has been shown to be associated with an up to 40% reduction in hospitalisation rates and a 20% reduction in Emergency Department attendances and similar benefits in terms of symptoms and time off work. In asthma, the results are best when the patients are provided with a personalised written action plan explaining how to alter their medications according to a variety of circumstances. Chronic obstructive pulmonary disease is a major cause of hospitalisation in the U.K. and is the fourth biggest single cause of death. A recent Cochrane review regarding the value of self management education in COPD has led to equivocal results although it has shown that those with COPD are willing to take control of their own conditions. The reasons for different outcomes in asthma and COPD may reflect an inadequate number of trials of the wrong type; interventions that were not appropriate or do not work; lack of the use of written action plans; or assessment of benefit using the wrong outcomes.
Given the importance attached to the written action plan, it is essential that such advice is available to all. However studies of outpatients attending hospitals in the U.K. have shown that 15% may be functionally illiterate and in studies of adults with asthma in the U.S., 13% have similarly shown to be functionally illiterate. Pictorial advice may therefore be advantageous and when tested amongst those who are literate, it has been also shown to enhance the recall of spoken medical instructions. The investigators have therefore prepared some pictorial representations which are designed to give advice to those with asthma and COPD about how to recognise the worsening of their conditions and what treatments to alter or initiate as a result. The investigators now need to assess the comprehensibility of those materials amongst a selection of patients with asthma and COPD.
Patients will be recruited from two clinics (asthma and COPD) on a Tuesday morning and Thursday afternoon.
On arrival to the Asthma clinic and to the COPD clinic, patients will be given a short information leaflet which they will be invited to read whilst waiting to see the doctor. At the end of the routine consultation they will be asked if they would be willing to help with the study and will be given a patient information sheet and if the patient agrees he/she, will be asked to sign the consent form. The voluntary nature of this and the fact that non-participation will not in any way influence their routine care would be stressed repetitively, both verbally and of course in the patient information leaflet. If the patients were willing to spend a few minutes with the researcher, they would be introduced to the researcher by the consultant in clinic and the interview would either occur on that occasion or at a pre-arranged time to suit the patient. In the first part of the interview, the patient would be given the two pictorial questionnaires to complete which assess the translucency and guessability of the pictogram used for the investigators' pictorial action plans. The second part of the interview would involve explaining to the patient the concept of self management education and personal action plans and a pictorial action plan relevant to the patient would be shown to the patient and he/she would be asked to describe what action should be taken as a result of the pictorial sequences. A series of short questions about the self management plan and his/her preferences for either written or a pictorial plan would be asked. The patient would also be asked to undertake the REALM adult literacy test and demographic data regarding educational attainment, age and ethnicity would also be recorded.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
London, United Kingdom, W6 8RF
- NHLI Imperial College
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Understanding of spoken English language
- Evidence of respiratory disease (either asthma or COPD)
Exclusion Criteria:
- Poor level of English language; English not first language
- Poor eyesight or literacy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention arm
Pictorial action plan
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recall and understanding after pictorial self management education
Time Frame: Baseline only
|
information recall after education
|
Baseline only
|
|
Translucency and guessability scores comprehensibility
Time Frame: Baseline
|
This outcome measure provides score for each image used in the plan
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Martyn R Partridge, MD FRCP, Imperial College London
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NHLICX04Q0401103
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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