AsthmaNCT00129662
Comprehension and Evaluation of a Pictorial Action Plan for Those With Asthma or COPD
A study testing Pictorial action plan in people with Asthma and COPD, run by Imperial College London at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- What is being tested?
- Pictorial action plan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2005to Jan 2010
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Understanding of spoken English language
- Evidence of respiratory disease (either asthma or COPD)
Who cannot join
- Poor level of English language; English not first language
- Poor eyesight or literacy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Pictorial action plan
- Keywords
- Pictorial action plan
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pictorial action planBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Pictorial action plan Receives: Behavioral: Pictorial action plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recall and understanding after pictorial self management education
information recall after education
Measured: Baseline only
Translucency and guessability scores comprehensibility
This outcome measure provides score for each image used in the plan
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2005 (estimated)
- Study startJan 2005
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martyn R Partridge, MD FRCP, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00129662
- Sponsor's protocol ID
- NHLICX04Q0401103
- Status last verified
- Oct 2019
- First submitted
- 11 Aug 2005
- Last updated
- 7 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roberts NJ, Evans G, Blenkhorn P, Partridge MR. Development of an electronic pictorial asthma action plan and its use in primary care. Patient Educ Couns. 2010 Jul;80(1):141-6. doi: 10.1016/j.pec.2009.09.040. Epub 2009 Oct 29.
PubMed 19879092
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehension and Evaluation of a Pictorial Action Plan for Those With Asthma or Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT00129662
- Acronym / sponsor ID
- NHLICX04Q0401103
- Keywords
- Pictorial action plan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Jan 2005 (actual)
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 12 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Pictorial action planPictorial action plan |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Understanding of spoken English language
- Evidence of respiratory disease (either asthma or COPD)
Key exclusion criteria (2 listed)
- Poor level of English language; English not first language
- Poor eyesight or literacy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pictorial action plan | Behavioural | Intervention arm |
Primary outcome
Recall and understanding after pictorial self management education
Time frame: Baseline only
information recall after education
Translucency and guessability scores comprehensibility
Time frame: Baseline
This outcome measure provides score for each image used in the plan
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2019.
- Results publication: PubMed 19879092Roberts NJ, Evans G, Blenkhorn P, Partridge MR. Development of an electronic pictorial asthma action plan and its use in primary care. Patient Educ Couns. 2010 Jul;80(1):141-6. doi: 10.1016/j.pec.2009.09.040. Epub 2009 Oct 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martyn R Partridge, MD FRCP principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pictorial action plan in people with Asthma and COPD, run by Imperial College London 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 2 inclusion and 2 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 7 Oct 2019. 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?
Recall and understanding after pictorial self management education (time frame: Baseline only). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00129662, which also lists 1 linked publication.
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 7 Oct 2019.