Clinical Impact of MI on Inhaled Antibiotic Adherence in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04017559
• Other study ID #: 14074DD-AS
• Status: Completed
• Phase: N/A
• Start date: October 22, 2014
• Est. completion date: May 17, 2017

Study information

• Verified date: July 2019
• Source: Belfast Health and Social Care Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 17, 2017
• Est. primary completion date: September 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Behavioral:
• Motivational Interviewing
A pharmacist trained in MI delivered three recorded MI sessions over 2 months, with follow up at 3, 4 and 6 months.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Belfast Health and Social Care Trust	Queen's University, Belfast

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percent Predicted Forced Expiratory Volume in 1 second (ppFEV1)	Change in ppFEV1 from start of study to end of study (6 months)	6 months
Secondary	Body Mass Index (BMI)	Change in BMI from start of study to end of study (6 months)	6 months
Secondary	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
Secondary	Treatment quality and satisfaction (TQSM)	Change in TQSM from start to end of intervention period	6 months
Secondary	Self reported adherence using "Moriskey Medication Adherence 8" questionnaire (MMAS-8)	Change in MMAS-8 from start to end of intervention period	6 months
Secondary	Density of Pseudomonas growth in sputum	Change in density of pseudomonas growth from start to end of intervention period	6 months
Secondary	Quality of life measured by CFQ-R	Change in quality of life from start to end of intervention period	6 months