Clinical Impact of MI on Inhaled Antibiotic Adherence in Cystic Fibrosis

Belfast Health and Social Care Trust

Status: Completed

Conditions: Cystic Fibrosis

Treatments: Behavioral: Motivational Interviewing

Study type: Interventional

Funder types: Other

Identifiers

NCT04017559

14074DD-AS

Details and patient eligibility

About

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).

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Intervention cohort

Experimental group

Description:

All participants were entered into the intervention cohort to receive the Motivational Interviewing intervention

Treatment:

Behavioral: Motivational Interviewing