Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00129662
Status:
COMPLETED
Last Update Posted:
2019-10-07
First Post:
2005-08-11
Brief Title:
Comprehension and Evaluation of a Pictorial Action Plan for Those With Asthma or COPD
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
Comprehension and Evaluation of a Pictorial Action Plan for Those With Asthma or Chronic Obstructive Pulmonary Disease
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Some five million people in the United Kingdom UK 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 UK 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 UK have shown that 15 may be functionally illiterate and in studies of adults with asthma in the United States US 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
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 UK have shown that 15 may be functionally illiterate and in studies of adults with asthma in the United States US 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
Detailed Description:
Some five million people in the UK 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 UK 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 UK have shown that 15 may be functionally illiterate and in studies of adults with asthma in the US 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 heshe 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 heshe 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 hisher 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
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 UK have shown that 15 may be functionally illiterate and in studies of adults with asthma in the US 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 heshe 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 heshe 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 hisher 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None