Clinical Impact of MI on Inhaled Antibiotic Adherence in Cystic Fibrosis
Assessing the Clinical Impact of Motivational Interviewing on Inhaled Antibiotic Adherence in Cystic Fibrosis
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients that do not expectorate sputum spontaneously
- Inability to complete questionnaires
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Intervention cohort
All participants were entered into the intervention cohort to receive the Motivational Interviewing intervention
|
A pharmacist trained in MI delivered three recorded MI sessions over 2 months, with follow up at 3, 4 and 6 months.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Inhaled Antibiotic collection percentage
時間枠：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
|
6 months preceding intervention compared to end of 6 month intervention period
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percent Predicted Forced Expiratory Volume in 1 second (ppFEV1)
時間枠：6 months
|
Change in ppFEV1 from start of study to end of study (6 months)
|
6 months
|
|
Body Mass Index (BMI)
時間枠：6 months
|
Change in BMI from start of study to end of study (6 months)
|
6 months
|
|
Need for additional Intra-venous or oral antibiotics
時間枠：6 months
|
change in additional antibiotic days from 6 months preceding the intervention to end of intervention period
|
6 months
|
|
Treatment quality and satisfaction (TQSM)
時間枠：6 months
|
Change in TQSM from start to end of intervention period
|
6 months
|
|
Self reported adherence using "Moriskey Medication Adherence 8" questionnaire (MMAS-8)
時間枠：6 months
|
Change in MMAS-8 from start to end of intervention period
|
6 months
|
|
Density of Pseudomonas growth in sputum
時間枠：6 months
|
Change in density of pseudomonas growth from start to end of intervention period
|
6 months
|
|
Quality of life measured by CFQ-R
時間枠：6 months
|
Change in quality of life from start to end of intervention period
|
6 months
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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