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CompletedNCT04017559Updated Jul 12, 2019

Clinical Impact of MI on Inhaled Antibiotic Adherence in Cystic Fibrosis

An interventional study of Motivational Interviewing in Cystic Fibrosis, sponsored by Belfast Health and Social Care Trust. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-12.

Sponsored by Belfast Health and Social Care Trust · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 4 years 8 months after the study started (first participant enrolled Oct 2014, registered Jul 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Cystic Fibrosis
03

In context

Cystic Fibrosis

1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.

This study's enrollment of 22 is below the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.

Browse Cystic Fibrosis studies →

Lead sponsor

Belfast Health and Social Care Trust is the lead sponsor of 43 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  1. Patients that do not expectorate sputum spontaneously
  2. Inability to complete questionnaires
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    Intervention cohort

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

    Behavioral: Motivational Interviewing

Interventions

  • BehavioralMotivational Interviewing

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

06

What researchers measure

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

    Time frame: 6 months preceding intervention compared to end of 6 month intervention period

Secondary outcomes

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

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

    Time frame: 6 months

  2. Body Mass Index (BMI)

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

    Time frame: 6 months

  3. Need for additional Intra-venous or oral antibiotics

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

    Time frame: 6 months

  4. Treatment quality and satisfaction (TQSM)

    Change in TQSM from start to end of intervention period

    Time frame: 6 months

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

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

    Time frame: 6 months

  6. Density of Pseudomonas growth in sputum

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

    Time frame: 6 months

  7. Quality of life measured by CFQ-R

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

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04017559
Lead sponsor
Belfast Health and Social Care Trust
Collaborators
Queen's University, Belfast
Responsible party
Sponsor
First posted
Jul 12, 2019
Start date
Oct 22, 2014
Primary completion
Sep 1, 2016
Completion
May 17, 2017
Last update
Jul 12, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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