Clinical trial NCT04017559: Clinical Impact of MI on Inhaled Antibiotic Adherence in Cystic Fibrosis
Official title: Assessing the Clinical Impact of Motivational Interviewing on Inhaled Antibiotic Adherence in Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: Belfast Health and Social Care Trust
Sponsor class: OTHER
Collaborators: name: Queen's University, Belfast
First posted: 2019-07-12
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Patients that do not expectorate sputum spontaneously
2. Inability to complete questionnaires

Primary outcomes:
measure: Inhaled Antibiotic collection percentage
timeFrame: 6 months preceding intervention compared to end of 6 month intervention period
Secondary outcomes:
measure: Percent Predicted Forced Expiratory Volume in 1 second (ppFEV1)
timeFrame: 6 months
measure: Body Mass Index (BMI)
timeFrame: 6 months
measure: Need for additional Intra-venous or oral antibiotics
timeFrame: 6 months
measure: Treatment quality and satisfaction (TQSM)
timeFrame: 6 months
measure: Self reported adherence using "Moriskey Medication Adherence 8" questionnaire (MMAS-8)
timeFrame: 6 months
measure: Density of Pseudomonas growth in sputum
timeFrame: 6 months
measure: Quality of life measured by CFQ-R
timeFrame: 6 months
Other outcomes:
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