Evaluation of the Benefits of an Individualised Menu Driven Nurse Led Programme to Improve Adherence in Difficult Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Adherence to Inhaled combination therapy
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.-
研究组 & 干预措施
usual care
Standard asthma management
Psycho-educational intervention
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
干预措施: Pyscho-behavioural (Behavioral)
结局指标
主要结局
Adherence to Inhaled combination therapy
时间窗: 6 months
次要结局
- Asthma control score(6 months)
- Asthma Quality of Life Questionnaire(6 months)
- Hospital anxiety and depression scale(6 months)
- Lung function(6 months)
- Reduction in rescue courses of Steroids(6 months)
研究者
Liam Heaney
Doctor
Belfast Health and Social Care Trust