AsthmaNCT01064869
A Nurse Led Programme to Improve Adherence in Difficult Asthma
A study testing Pyscho-behavioural in people with Asthma, run by Belfast Health and Social Care Trust at 1 site in United Kingdom.
Trial summary
Approximately 5% of adults with asthma have difficult to control disease but these account for up to 80% of total cost of asthma due to recurrent healthcare contact including hospital admission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Pyscho-behavioural
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2005to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Filling <50% of prescription refills for inhaled combination therapy
- Persisting asthma symptoms (ACS >3) despite detailed assessment and management
- Minimal maintenance therapy of long acting beta2-agonist and inhaled steroids (800mg BDP or equivalent)
- At least 1 course of systemic steroids in the preceding 12 months.
Who cannot join
- Medication adherence
- A condition other than asthma contributing to persisting symptoms
- Current smoker
- Ex-smoker > 10 pack years -Significant co-morbidity due to condition other than asthma.-
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Regional Respiratory Centre, Belfast City Hospital
Belfast, Co Down, BT 9 7AB
About this study
Official title: Evaluation of the Benefits of an Individualised Menu Driven Nurse Led Programme to Improve Adherence in Difficult Asthma
Approximately 5% of adults with asthma have difficult to control disease but these account for up to 80% of total cost of asthma due to recurrent healthcare contact including hospital admission. The reasons for "difficult asthma" are multi-factorial, but an important element in many patients is non-adherence to steroid therapy. Recent qualitative analysis by the investigators group has identified a number of both individual and group themes, related to non-adherence with steroid treatment. Many of these themes such as steroid phobia, inaccurate / lack of knowledge, negative attitudes and inability to deal with side-effects, are potentially modifiable and the investigators believe, unless these issues are addressed, at an individual patient level, adherence is unlikely to improve. This randomised parallel group study will examine a nursing intervention to try and improve adherence and as a consequence, asthma control, in a group of difficult asthmatics where non-adherence has been identified as a significant factor. The study will use a needs-led menu driven individualised intervention and will compare this to current best asthma care. The primary outcome measure will be adherence to therapy, however asthma control, lung function and asthma related quality of life, patients' attitudes to asthma and treatment and their levels of anxiety and depression will also be examined. Addressing the issue of non-adherence is fundamental to improving asthma management in this difficult group with concomitant reduction on health care costs and improvements in patients' quality of life
Read the detailed description
Plan of investigation The study will be a single blind randomised controlled trial. Patients will be recruited from those attending the difficult asthma clinic at the Belfast City Hospital and deemed non-adherent (see below). Difficult asthma will be defined as; 1. persisting asthma symptoms (Asthma control score >3)(ACS), despite detailed assessment and management; 2. minimal maintenance therapy of long acting B2-agonist and inhaled steroids ( 800 mcg BDP or equivalent) and 3. at least 1 course of systemic steroids in the preceding 12 months.
Non adherence will be defined as prescription filling of <50% of prescribed anti-inflammatory inhaled therapy utilized in preceding 6 months (from GP prescription records). All subjects will be invited to take part and give consent to take part in the study.
Exclusion criteria will be medication adherence, a condition other than asthma contributing to persisting symptoms; current smoker; significant co-morbidity due to condition other than asthma. Primary Outcome measure Improvement in adherence to steroid therapy before and after intervention (both 7 day prednisolone (serum assay) and inhaled steroid therapy (prescription counting).
Secondary outcome measures Improvement in Asthma Control Scores (ACS) Improvement in asthma Quality of Life Questionnaire (AQLQ) Improvement in Lung function Reduction in courses of rescue steroid Hospital Anxiety and Depression Scale These are all routinely measured as part of the difficult asthma service. Study design Pre run-in period
- Assessment of inclusion / exclusion criteria
- Full informed consent Run-in period (1 week)- All participants Week 1 Prednisolone course - 7 day course
- ACS/Forced expiratory volume in 1 second (FEV1) on Day 1 (Lung function breathing test) 2. Serum prednisolone/cortisol and urinary cortisol/creatinine ratio on Day 7 - measures adherence to prednisolone 3. Asthma control score/FEV1 Day 7 Randomisation Patients will be randomized into two groups either control (usual care) or intervention group using a random number generator.
Intervention
Intervention Group- A nurse-led programme of intervention will be devised. It will have two stages incorporating:
- Semi-structured audio taped interview to identify individual reasons for non-adherence and assessment of readiness to change behaviour.
- An individualised package incorporating:
- Asthma education programme to address any specific gaps in asthma knowledge or requests for information
- Motivational interviewing based on stages of change model to encourage change and adherence
- Psychological therapy involving (a) relaxation therapy (b) cognitive behavioural techniques looking at negative and catastrophic thoughts and (c) panic cycle adapted to respiratory patients Patients will be seen regularly (individual needs determine time spans) for a period of 3 months.
Control group - standard asthma management. Outcome measures Primary outcome measures Adherence will be determined at baseline, 3 and 9 months by prescription filling to define outcome after completion of programme. During the period of follow-up, when a further 7 day course of prednisolone is indicated on clinical grounds, serum prednisolone/cortisol and urinary cortisol/creatinine ratio will be measured on completion of course.
Secondary outcome measures These will be measured at 3 and 9 months There are currently 200 patients attending the difficult asthma service at Belfast City Hospital Trust all of whom fulfil our definition of difficult asthma. No data is available in this specific population regarding adherence with inhaled therapy but based on adherence with prednisolone and adherence data with inhaled therapy in other severities of asthma, we would anticipate that over 50% will be variably adherent to therapy. 1-6 months - Screening population / liaising with primary care / psychological intervention training 6 months-18 months - Patient recruitment and intervention package delivered 18-36 months- Follow-up and data analysis.
- Conditions
- Asthma
- Being tested
- Pyscho-behavioural
- Keywords
- Adherence, Asthma, medication
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyscho-behaviouralBehavioural
A nurse-led programme of intervention will be devised. Patients will attend weekly for a period of 12 weeks. It will have two stages incorporating:
- Structured interview to identify demographic information and individual reasons for non-adherence and assessment of readiness to change behaviour
This will be followed by an individualised package incorporating:
- A structured asthma education programme, to address any gaps in asthma knowledge or requests for information
- Motivational interviewing based on stages of change model to encourage change and adherence
- Psychological therapy involving (a) relaxation therapy (b) cognitive behavioural techniques looking at negative and catastrophic thoughts and (c) panic cycle adapted to respiratory patients
| Study group | Role | What they receive |
|---|---|---|
| Psycho-educational intervention | Experimental | A nurse-led programme of intervention will be devised. Patients will attend weekly for a period of 12 weeks. It will have two stages incorporating:
1. Structured interview to identify demographic information and individual reasons for non-adherence and assessment of readiness to change behaviour
This will be followed by an individualised package incorporating:
1. A structured asthma education programme, to address any gaps in asthma knowledge or requests for information
2. Motivational interviewing based on stages of change model to encourage change and adherence
3. Psychological therapy involving (a) relaxation therapy (b) cognitive behavioural techniques looking at negative and catastrophic thoughts and (c) panic cycle adapted to respiratory patients Receives: Behavioral: Pyscho-behavioural |
| usual care | No intervention | Standard asthma management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Inhaled combination therapy
Measured: 6 months
Secondary outcomes (5)
Asthma control score
Measured: 6 months
Asthma Quality of Life Questionnaire
Measured: 6 months
Hospital anxiety and depression scale
Measured: 6 months
Lung function
Measured: 6 months
Reduction in rescue courses of Steroids
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2010 (estimated)
- Study startJan 2005
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Belfast Health and Social Care Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liam Heaney, Belfast Health and Social Care Trust
- Investigators
- Liam Heaney, MD, Principal investigator, Belfast Health and Social Care Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01064869
- Sponsor's protocol ID
- 05/NIR/03/32
- Status last verified
- Mar 2016
- First submitted
- 8 Feb 2010
- Last updated
- 15 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Benefits of an Individualised Menu Driven Nurse Led Programme to Improve Adherence in Difficult Asthma
- ClinicalTrials.gov ID
- NCT01064869
- Acronym / sponsor ID
- 05/NIR/03/32
- Conditions
- Asthma
- Keywords
- Adherence, Asthma, medication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Belfast Health and Social Care TrustUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 9 Feb 2010 (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.
Approximately 5% of adults with asthma have difficult to control disease but these account for up to 80% of total cost of asthma due to recurrent healthcare contact including hospital admission. The reasons for "difficult asthma" are multi-factorial, but an important element in many patients is non-adherence to steroid therapy. Recent qualitative analysis by the investigators group has identified a number of both individual and group themes, related to non-adherence with steroid treatment. Many of these themes such as steroid phobia, inaccurate / lack of knowledge, negative attitudes and inability to deal with side-effects, are potentially modifiable and the investigators believe, unless these issues are addressed, at an individual patient level, adherence is unlikely to improve. This randomised parallel group study will examine a nursing intervention to try and improve adherence and as a consequence, asthma control, in a group of difficult asthmatics where non-adherence has been identified as a significant factor. The study will use a needs-led menu driven individualised intervention and will compare this to current best asthma care. The primary outcome measure will be adherence to therapy, however asthma control, lung function and asthma related quality of life, patients' attitudes to asthma and treatment and their levels of anxiety and depression will also be examined. Addressing the issue of non-adherence is fundamental to improving asthma management in this difficult group with concomitant reduction on health care costs and improvements in patients' quality of life
Detailed description
Plan of investigation The study will be a single blind randomised controlled trial. Patients will be recruited from those attending the difficult asthma clinic at the Belfast City Hospital and deemed non-adherent (see below). Difficult asthma will be defined as; 1. persisting asthma symptoms (Asthma control score >3)(ACS), despite detailed assessment and management; 2. minimal maintenance therapy of long acting B2-agonist and inhaled steroids ( 800 mcg BDP or equivalent) and 3. at least 1 course of systemic steroids in the preceding 12 months.
Non adherence will be defined as prescription filling of <50% of prescribed anti-inflammatory inhaled therapy utilized in preceding 6 months (from GP prescription records). All subjects will be invited to take part and give consent to take part in the study.
Exclusion criteria will be medication adherence, a condition other than asthma contributing to persisting symptoms; current smoker; significant co-morbidity due to condition other than asthma. Primary Outcome measure Improvement in adherence to steroid therapy before and after intervention (both 7 day prednisolone (serum assay) and inhaled steroid therapy (prescription counting).
Secondary outcome measures Improvement in Asthma Control Scores (ACS) Improvement in asthma Quality of Life Questionnaire (AQLQ) Improvement in Lung function Reduction in courses of rescue steroid Hospital Anxiety and Depression Scale These are all routinely measured as part of the difficult asthma service. Study design Pre run-in period
- Assessment of inclusion / exclusion criteria
- Full informed consent Run-in period (1 week)- All participants Week 1 Prednisolone course - 7 day course
- ACS/Forced expiratory volume in 1 second (FEV1) on Day 1 (Lung function breathing test) 2. Serum prednisolone/cortisol and urinary cortisol/creatinine ratio on Day 7 - measures adherence to prednisolone 3. Asthma control score/FEV1 Day 7 Randomisation Patients will be randomized into two groups either control (usual care) or intervention group using a random number generator.
Intervention
Intervention Group- A nurse-led programme of intervention will be devised. It will have two stages incorporating:
- Semi-structured audio taped interview to identify individual reasons for non-adherence and assessment of readiness to change behaviour.
- An individualised package incorporating:
- Asthma education programme to address any specific gaps in asthma knowledge or requests for information
- Motivational interviewing based on stages of change model to encourage change and adherence
- Psychological therapy involving (a) relaxation therapy (b) cognitive behavioural techniques looking at negative and catastrophic thoughts and (c) panic cycle adapted to respiratory patients Patients will be seen regularly (individual needs determine time spans) for a period of 3 months.
Control group - standard asthma management. Outcome measures Primary outcome measures Adherence will be determined at baseline, 3 and 9 months by prescription filling to define outcome after completion of programme. During the period of follow-up, when a further 7 day course of prednisolone is indicated on clinical grounds, serum prednisolone/cortisol and urinary cortisol/creatinine ratio will be measured on completion of course.
Secondary outcome measures These will be measured at 3 and 9 months There are currently 200 patients attending the difficult asthma service at Belfast City Hospital Trust all of whom fulfil our definition of difficult asthma. No data is available in this specific population regarding adherence with inhaled therapy but based on adherence with prednisolone and adherence data with inhaled therapy in other severities of asthma, we would anticipate that over 50% will be variably adherent to therapy. 1-6 months - Screening population / liaising with primary care / psychological intervention training 6 months-18 months - Patient recruitment and intervention package delivered 18-36 months- Follow-up and data analysis.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psycho-educational intervention | Experimental | Behavioral: Pyscho-behaviouralA nurse-led programme of intervention will be devised. Patients will attend weekly for a period of 12 weeks. It will have two stages incorporating: 1. Structured interview to identify demographic information and individual reasons for non-adherence and assessment of readiness to change behaviour This will be followed by an individualised package incorporating: 1. A structured asthma education programme, to address any gaps in asthma knowledge or requests for information 2. Motivational interviewing based on stages of change model to encourage change and adherence 3. Psychological therapy involving (a) relaxation therapy (b) cognitive behavioural techniques looking at negative and catastrophic thoughts and (c) panic cycle adapted to respiratory patients |
| usual care | No intervention | –Standard asthma management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Filling <50% of prescription refills for inhaled combination therapy
- Persisting asthma symptoms (ACS >3) despite detailed assessment and management
- Minimal maintenance therapy of long acting beta2-agonist and inhaled steroids (800mg BDP or equivalent)
- At least 1 course of systemic steroids in the preceding 12 months.
Key exclusion criteria (4 listed)
- Medication adherence
- A condition other than asthma contributing to persisting symptoms
- Current smoker
- Ex-smoker > 10 pack years -Significant co-morbidity due to condition other than asthma.-
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 |
|---|---|---|
| Pyscho-behaviouralA nurse-led programme of intervention will be devised. Patients will attend weekly for a period of 12 weeks. It will have two stages incorporating: 1. Structured interview to identify demographic information and individual reasons for non-adherence and assessment of readiness to change behaviour This will be followed by an individualised package incorporating: 1. A structured asthma education programme, to address any gaps in asthma knowledge or requests for information 2. Motivational interviewing based on stages of change model to encourage change and adherence 3. Psychological therapy involving (a) relaxation therapy (b) cognitive behavioural techniques looking at negative and catastrophic thoughts and (c) panic cycle adapted to respiratory patients | Behavioural | Psycho-educational intervention |
Primary outcome
Adherence to Inhaled combination therapy
Time frame: 6 months
5 secondary outcomes
Asthma control score
Time frame: 6 months
Asthma Quality of Life Questionnaire
Time frame: 6 months
Hospital anxiety and depression scale
Time frame: 6 months
Lung function
Time frame: 6 months
Reduction in rescue courses of Steroids
Time frame: 6 months
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 15 Mar 2016.
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Asthma
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.
Liam Heaney, MD principal investigator
Belfast Health and Social Care Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pyscho-behavioural in people with Asthma, run by Belfast Health and Social Care Trust 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 4 inclusion and 4 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 15 Mar 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?
Adherence to Inhaled combination therapy (time frame: 6 months). 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 15 Mar 2016.