Clinical Impact of MI on Inhaled Antibiotic Adherence in Cystic Fibrosis

Study Overview
=================
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.

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

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Behavioral: Motivational Interviewing


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention cohort<br>All participants were entered into the intervention cohort to receive the Motivational Interviewing intervention | Behavioral: Motivational Interviewing<br>* A pharmacist trained in MI delivered three recorded MI sessions over 2 months, with follow up at 3, 4 and 6 months.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inhaled Antibiotic collection percentage | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Predicted Forced Expiratory Volume in 1 second (ppFEV1) | Change in ppFEV1 from start of study to end of study (6 months) | 6 months | 
| Body Mass Index (BMI) | Change in BMI from start of study to end of study (6 months) | 6 months | 
| Need for additional Intra-venous or oral antibiotics | change in additional antibiotic days from 6 months preceding the intervention to end of intervention period | 6 months | 
| Treatment quality and satisfaction (TQSM) | Change in TQSM from start to end of intervention period | 6 months | 
| Self reported adherence using Moriskey Medication Adherence 8 questionnaire (MMAS-8) | Change in MMAS-8 from start to end of intervention period | 6 months | 
| Density of Pseudomonas growth in sputum | Change in density of pseudomonas growth from start to end of intervention period | 6 months | 
| Quality of life measured by CFQ-R | Change in quality of life from start to end of intervention period | 6 months |