Individualized Interventions to Improve Asthma Adherence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 397
- 试验地点
- 2
- 主要终点
- Adherence to prescribed inhaled steroid regimen
研究概览
简要总结
This is a randomized, controlled study that will compare two medication adherence strategies in adults with moderate or severe persistent asthma as a method for improving or maintaining treatment adherence.
详细描述
Low-income minority adults have excessively high rates of morbidity from asthma. Poor medication adherence has been documented in these individuals and contributes to the high morbidity level. This study will compare a Problem Solving intervention with an Attention Control intervention to improve and sustain asthma self-management in a clinical setting. This study will include strategies to address contextual factors related to adherence. Participants will be recruited from clinics that serve minority and low-income individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receiving treatment for asthma at one of the participating clinics
- •Moderate or severe persistent asthma according to the NHLBI Guidelines
- •Current use of prescribed inhaled corticosteroids
- •Evidence of reversible airflow obstruction, as indicated by the following two criteria:
- •FEV1pp AND less than 80% at the time of study entry or within the 3 years prior to study entry
- •An increase of greater than 15% and 200ml in FEV1 with asthma treatment over the last 3 years (if there is no record of such improvement, participants will be evaluated via spirometry pre- and post-bronchodilator at the first study visit. An increase in FEV1 or FVC greater than 12% and 200 ml in FEV1 30 minutes following albuterol administration will represent evidence of reversible airflow obstruction. If a spirometer is not immediately available, participants may be evaluated using a peak flow meter, which reports a PEF. A PEFpp less than 80% and an improvement of at least 60 L per minute after the administration of albuterol will represent evidence of reversible airflow obstruction)
- •Has a functional telephone or mobile phone
排除标准
- •Significant lung or cardiac disease (other than hypertension)
- •Psychiatric illness, such as mania or schizophrenia, that may make it impossible to understand or carry out the Problem Solving intervention
研究组 & 干预措施
2
Attention control intervention
干预措施: Attention Control (Behavioral)
1
Problem solving intervention
干预措施: Problem Solving (Behavioral)
结局指标
主要结局
Adherence to prescribed inhaled steroid regimen
时间窗: Measured at Week 26
次要结局
- FEV1(Measured at Week 26)
- Quality of life factors(Measured at Week 26)
研究者
Andrea Apter
Professor of Medicine
University of Pennsylvania