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临床试验/NCT04017559
NCT04017559已完成不适用

Assessing the Clinical Impact of Motivational Interviewing on Inhaled Antibiotic Adherence in Cystic Fibrosis

Belfast Health and Social Care Trust0 个研究点目标入组 22 人开始时间: 2014年10月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
22
主要终点
Inhaled Antibiotic collection percentage

研究概览

简要总结

Adherence to treatment is a major challenge in cystic fibrosis (CF). Motivational Interviewing (MI) is increasingly used to address this, but its effectiveness is unknown. We investigated the clinical impact of an MI intervention, delivered by a specifically trained pharmacist, on adherence to inhaled antibiotics (IA).

详细描述

Adherence to treatment is a major challenge in cystic fibrosis (CF). Motivational Interviewing (MI) is increasingly used to address this, but its effectiveness is unknown. We investigated the clinical impact of an MI intervention, delivered by a specifically trained pharmacist, on adherence to inhaled antibiotics (IA).

Adults with CF were recruited through the Regional CF Centre. A pharmacist trained in MI delivered three recorded MI sessions over 2 months, with follow up at 3, 4 and 6 months. Demographics, ppFEV1, BMI, adherence (IA collection rates) and additional antibiotic use were collected during the study and for 6 months prior. Treatment Quality and Satisfaction (TQSM), self-reported adherence (Moriskey Medication Adherence Scale-8 (MMAS-8)), Quality Of Life (CF Questionnaire-Revised (CFQ-R)) and sputum Pseudomonas aeruginosa (Pa) density were assessed at each study visit. Statistical analysis compared outcomes pre and post-intervention and variation during the intervention period.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

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

  • Male or female patients with a documented diagnosis of CF aged ≥18 years on the date of informed consent
  • Known chronic infection with Pa, as defined by the Leeds criteria
  • Has been prescribed inhaled colomycin and/or tobramycin and/or aztreonam for a minimum of 3 months prior to study enrolment
  • Able to provide written informed consent
  • Able to understand and comply with protocol requirements and instructions
  • Has been identified by the physician during routine appointments as having difficulties with adherence to their inhaled therapies

排除标准

  • Patients that do not expectorate sputum spontaneously
  • Inability to complete questionnaires

研究组 & 干预措施

Intervention cohort

Experimental

All participants were entered into the intervention cohort to receive the Motivational Interviewing intervention

干预措施: Motivational Interviewing (Behavioral)

结局指标

主要结局

Inhaled Antibiotic collection percentage

时间窗: 6 months preceding intervention compared to end of 6 month intervention period

Change in adherence to Inhaled Antibiotic measured by collection from pharmacy in 6 months before intervention and at end of intervention

次要结局

  • Quality of life measured by CFQ-R(6 months)
  • Treatment quality and satisfaction (TQSM)(6 months)
  • Self reported adherence using "Moriskey Medication Adherence 8" questionnaire (MMAS-8)(6 months)
  • Density of Pseudomonas growth in sputum(6 months)
  • Body Mass Index (BMI)(6 months)
  • Percent Predicted Forced Expiratory Volume in 1 second (ppFEV1)(6 months)
  • Need for additional Intra-venous or oral antibiotics(6 months)

研究者

申办方类型
Other
责任方
Sponsor

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