Clinical Impact of MI on Inhaled Antibiotic Adherence in Cystic Fibrosis
- Conditions
- Cystic Fibrosis
- Interventions
- Behavioral: Motivational Interviewing
- Registration Number
- NCT04017559
- Lead Sponsor
- Belfast Health and Social Care Trust
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
- 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
- Patients that do not expectorate sputum spontaneously
- Inability to complete questionnaires
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention cohort Motivational Interviewing All participants were entered into the intervention cohort to receive the Motivational Interviewing intervention
- Primary Outcome Measures
Name Time Method Inhaled Antibiotic collection percentage 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
- Secondary Outcome Measures
Name Time Method Quality of life measured by CFQ-R 6 months Change in quality of life from start to end of intervention period
Treatment quality and satisfaction (TQSM) 6 months Change in TQSM from start to end of intervention period
Self reported adherence using "Moriskey Medication Adherence 8" questionnaire (MMAS-8) 6 months Change in MMAS-8 from start to end of intervention period
Density of Pseudomonas growth in sputum 6 months Change in density of pseudomonas growth from start to end of intervention period
Body Mass Index (BMI) 6 months Change in BMI from start of study to end of study (6 months)
Percent Predicted Forced Expiratory Volume in 1 second (ppFEV1) 6 months Change in ppFEV1 from start of study to end of study (6 months)
Need for additional Intra-venous or oral antibiotics 6 months change in additional antibiotic days from 6 months preceding the intervention to end of intervention period