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Completed

NCT Number: NCT04017559

Clinical Impact of MI on Inhaled Antibiotic Adherence in Cystic Fibrosis

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motivational Interviewing

Behavioral

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

Primary outcomes

  1. Inhaled Antibiotic collection percentage

    Time frame: 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 outcomes

  1. Percent Predicted Forced Expiratory Volume in 1 second (ppFEV1)

    Time frame: 6 months

    Change in ppFEV1 from start of study to end of study (6 months)

  2. Body Mass Index (BMI)

    Time frame: 6 months

    Change in BMI from start of study to end of study (6 months)

  3. Need for additional Intra-venous or oral antibiotics

    Time frame: 6 months

    change in additional antibiotic days from 6 months preceding the intervention to end of intervention period

  4. Treatment quality and satisfaction (TQSM)

    Time frame: 6 months

    Change in TQSM from start to end of intervention period

  5. Self reported adherence using "Moriskey Medication Adherence 8" questionnaire (MMAS-8)

    Time frame: 6 months

    Change in MMAS-8 from start to end of intervention period

  6. Density of Pseudomonas growth in sputum

    Time frame: 6 months

    Change in density of pseudomonas growth from start to end of intervention period

  7. Quality of life measured by CFQ-R

    Time frame: 6 months

    Change in quality of life from start to end of intervention period

Sponsors and collaborators

Lead sponsor

Belfast Health and Social Care Trust

Other

Collaborators

  • Queen's University, Belfast

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jul 12, 2019
Registry last updated
Jul 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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