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Clinical Impact of MI on Inhaled Antibiotic Adherence in Cystic Fibrosis

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Motivational Interviewing
Sponsored by
Belfast Health and Social Care Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cystic Fibrosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervention cohort

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Percent Predicted Forced Expiratory Volume in 1 second (ppFEV1)
    Change in ppFEV1 from start of study to end of study (6 months)
    Body Mass Index (BMI)
    Change in BMI from start of study to end of study (6 months)
    Need for additional Intra-venous or oral antibiotics
    change in additional antibiotic days from 6 months preceding the intervention to end of intervention period
    Treatment quality and satisfaction (TQSM)
    Change in TQSM from start to end of intervention period
    Self reported adherence using "Moriskey Medication Adherence 8" questionnaire (MMAS-8)
    Change in MMAS-8 from start to end of intervention period
    Density of Pseudomonas growth in sputum
    Change in density of pseudomonas growth from start to end of intervention period
    Quality of life measured by CFQ-R
    Change in quality of life from start to end of intervention period

    Full Information

    First Posted
    July 10, 2019
    Last Updated
    July 10, 2019
    Sponsor
    Belfast Health and Social Care Trust
    Collaborators
    Queen's University, Belfast
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04017559
    Brief Title
    Clinical Impact of MI on Inhaled Antibiotic Adherence in Cystic Fibrosis
    Official Title
    Assessing the Clinical Impact of Motivational Interviewing on Inhaled Antibiotic Adherence in Cystic Fibrosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    October 22, 2014 (Actual)
    Primary Completion Date
    September 1, 2016 (Actual)
    Study Completion Date
    May 17, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Belfast Health and Social Care Trust
    Collaborators
    Queen's University, Belfast

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cystic Fibrosis

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    22 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention cohort
    Arm Type
    Experimental
    Arm Description
    All participants were entered into the intervention cohort to receive the Motivational Interviewing intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Motivational Interviewing
    Intervention Description
    A pharmacist trained in MI delivered three recorded MI sessions over 2 months, with follow up at 3, 4 and 6 months.
    Primary Outcome Measure Information:
    Title
    Inhaled Antibiotic collection percentage
    Description
    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 Outcome Measure Information:
    Title
    Percent Predicted Forced Expiratory Volume in 1 second (ppFEV1)
    Description
    Change in ppFEV1 from start of study to end of study (6 months)
    Time Frame
    6 months
    Title
    Body Mass Index (BMI)
    Description
    Change in BMI from start of study to end of study (6 months)
    Time Frame
    6 months
    Title
    Need for additional Intra-venous or oral antibiotics
    Description
    change in additional antibiotic days from 6 months preceding the intervention to end of intervention period
    Time Frame
    6 months
    Title
    Treatment quality and satisfaction (TQSM)
    Description
    Change in TQSM from start to end of intervention period
    Time Frame
    6 months
    Title
    Self reported adherence using "Moriskey Medication Adherence 8" questionnaire (MMAS-8)
    Description
    Change in MMAS-8 from start to end of intervention period
    Time Frame
    6 months
    Title
    Density of Pseudomonas growth in sputum
    Description
    Change in density of pseudomonas growth from start to end of intervention period
    Time Frame
    6 months
    Title
    Quality of life measured by CFQ-R
    Description
    Change in quality of life from start to end of intervention period
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Clinical Impact of MI on Inhaled Antibiotic Adherence in Cystic Fibrosis

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