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
1 other identifier
interventional
22
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2014
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 17, 2017
CompletedFirst Submitted
Initial submission to the registry
July 10, 2019
CompletedFirst Posted
Study publicly available on registry
July 12, 2019
CompletedJuly 12, 2019
July 1, 2019
1.9 years
July 10, 2019
July 10, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Percent Predicted Forced Expiratory Volume in 1 second (ppFEV1)
6 months
Body Mass Index (BMI)
6 months
Need for additional Intra-venous or oral antibiotics
6 months
Treatment quality and satisfaction (TQSM)
6 months
Self reported adherence using "Moriskey Medication Adherence 8" questionnaire (MMAS-8)
6 months
- +2 more secondary outcomes
Study Arms (1)
Intervention cohort
EXPERIMENTALAll participants were entered into the intervention cohort to receive the Motivational Interviewing intervention
Interventions
A pharmacist trained in MI delivered three recorded MI sessions over 2 months, with follow up at 3, 4 and 6 months.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients that do not expectorate sputum spontaneously
- Inability to complete questionnaires
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Belfast Health and Social Care Trustlead
- Queen's University, Belfastcollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2019
First Posted
July 12, 2019
Study Start
October 22, 2014
Primary Completion
September 1, 2016
Study Completion
May 17, 2017
Last Updated
July 12, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share