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临床试验/NCT01132430
NCT01132430已完成3 期

Impact of a Motivational Interviewing Intervention on Medication Adherence in Patients With Asthma

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2008年6月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
50
试验地点
2
主要终点
Inhaled corticosteroid adherence

研究概览

简要总结

The high burden of asthma appears to be related to poor asthma control, which is associated with more frequent asthma symptoms, greater bronchodilator use and functional impairment, and worse pulmonary function. Despite the availability of effective treatments, more than 58% of asthmatics are poorly controlled. Daily adherence to inhaled corticosteroid (ICS) regimens is considered by experts to be one of the most important behavioral factors linked to achieving optimal asthma control. However, there is a paucity of research on interventions specifically designed to improve ICS adherence among adult asthmatics. The vast majority of intervention studies to date used atheoretical interventions to target behavior change, relying mainly upon educational approaches which have been criticised for "failing to translate knowledge into action." This may be due to the fact that most education-based approaches do not specifically address or help patients overcome ambivalence about behavior change, which is necessary for ensuring daily adherence. Motivational interviewing (MI) is a client-centred intervention that focuses on enhancing intrinsic motivation to change a particular behavior, and exploring and resolving ambivalence about behavior change. Brief MI sessions (e.g., 1-5 x 15-30 minute sessions) have been shown to improve a variety of health behaviors (e.g., reduce alcohol consumption, improve dietary habits, increase exercise behaviour, and improve medication adherence) and health outcomes (reduce blood pressure, body mass index, and cholesterol levels). However, no studies to date have assessed the efficacy of using MI to improve ICS adherence in asthmatics. This study aims to assess the efficacy of using MI to improve daily medication (ICS) adherence in a sample of poorly controlled, non-adherent asthmatics. It is hypothesized that patients randomized to the MI condition will exhibit significantly improved ICS adherence at 6 and 12-months post-intervention, independent of baseline levels and covariates, relative to patients randomized to the usual care control condition.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients 18 years and older
  • Primary diagnosis of moderate-severe persistent asthma (as per GINA)
  • Prescribed inhaled corticosteroid medication (min dose of 250 µg fluticasone equivalent per day) for at least 12 consecutive months
  • Uncontrolled asthma (≤ 19 on the Asthma Control Test)
  • Covered by a drug insurance plan (e.g., RAMQ)
  • Non-adherent to ICS medication (based on having filled less than 30% of their prescriptions over the last year)
  • Able to speak English or French.

排除标准

  • Any other medical condition that confers greater illness morbidity than asthma (e.g., active cancer)
  • Severe psychopathology (e.g., schizophrenia)
  • Apparent cognitive or language deficit
  • Are or plan to become pregnant or move outside of Quebec over the course of the study.

结局指标

主要结局

Inhaled corticosteroid adherence

时间窗: 12 months post-intervention

measured according to the following validated equation: # of treatment days (based on the # of canisters filled at the pharmacy x the duration of each prescription) divided by the # of prescription days (# of days the patient is expected to be taking his/her medication)

次要结局

  • Asthma Control Test(12 months post-intervention, with preliminary data collected at 6 months)
  • Asthma Control Questionnaire (Juniper)(12 months post-intervention, with preliminary data collected at 6 months)
  • Inhaled corticosteroid adherence(6 months post-intervention)
  • Asthma Self-Efficacy Scale (Tobin)(12 months post-intervention, with preliminary data collected at 6 months)
  • Asthma Quality of Life Questionnaire (Juniper)(12 months post-intervention, with preliminary data collected at 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Simon Bacon

Co-PI, PI is Dr. Kim Lavoie

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

研究点 (2)

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