An interventional study of Pyscho-behavioural in Asthma, sponsored by Belfast Health and Social Care Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-15.
Sponsored by Belfast Health and Social Care Trust · Not applicable, Interventional, and Health services research
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
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
Intervention
Intervention Group- A nurse-led programme of intervention will be devised. It will have two stages incorporating:
An individualised package incorporating:
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 20 is below the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Belfast Health and Social Care Trust is the lead sponsor of 43 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Filling \<50% of prescription refills for inhaled combination therapy
Exclusion Criteria:
Medication adherence
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
Behavioral: Pyscho-behavioural
Standard asthma management
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
Adherence to Inhaled combination therapy
Time frame: 6 months
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
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Belfast Health and Social Care Trust