Cystic FibrosisNCT04017559
Clinical Impact of MI on Inhaled Antibiotic Adherence in Cystic Fibrosis
A study testing Motivational Interviewing in people with Cystic Fibrosis, run by Belfast Health and Social Care Trust.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 22 Oct 2014to 17 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients that do not expectorate sputum spontaneously
- Inability to complete questionnaires
About this study
Official title: Assessing the Clinical Impact of Motivational Interviewing 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).
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.
- Conditions
- Cystic Fibrosis
- Being tested
- Motivational Interviewing
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
A pharmacist trained in MI delivered three recorded MI sessions over 2 months, with follow up at 3, 4 and 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Intervention cohort | Experimental | All participants were entered into the intervention cohort to receive the Motivational Interviewing intervention Receives: Behavioral: Motivational Interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months preceding intervention compared to end of 6 month intervention period
Secondary outcomes (7)
Percent Predicted Forced Expiratory Volume in 1 second (ppFEV1)
Change in ppFEV1 from start of study to end of study (6 months)
Measured: 6 months
Body Mass Index (BMI)
Change in BMI from start of study to end of study (6 months)
Measured: 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
Measured: 6 months
Treatment quality and satisfaction (TQSM)
Change in TQSM from start to end of intervention period
Measured: 6 months
Self reported adherence using "Moriskey Medication Adherence 8" questionnaire (MMAS-8)
Change in MMAS-8 from start to end of intervention period
Measured: 6 months
Density of Pseudomonas growth in sputum
Change in density of pseudomonas growth from start to end of intervention period
Measured: 6 months
Quality of life measured by CFQ-R
Change in quality of life from start to end of intervention period
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start22 Oct 2014
- Primary completion1 Sep 2016
- Study completion17 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Belfast Health and Social Care Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Queen's University, Belfast
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017559
- Sponsor's protocol ID
- 14074DD-AS
- Status last verified
- Jul 2019
- First submitted
- 10 Jul 2019
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Clinical Impact of Motivational Interviewing on Inhaled Antibiotic Adherence in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT04017559
- Acronym / sponsor ID
- 14074DD-AS
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Belfast Health and Social Care TrustUniversity, hospital or other
- Collaborators
- Queen's University, Belfast
- Study start
- 22 Oct 2014 (actual)
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 17 May 2017 (actual)
- First posted
- 12 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention cohort | Experimental | Behavioral: Motivational InterviewingAll participants were entered into the intervention cohort to receive the Motivational Interviewing intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Patients that do not expectorate sputum spontaneously
- Inability to complete questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational InterviewingA pharmacist trained in MI delivered three recorded MI sessions over 2 months, with follow up at 3, 4 and 6 months. | Behavioural | Intervention cohort |
Primary outcome
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
7 secondary outcomes
Percent Predicted Forced Expiratory Volume in 1 second (ppFEV1)
Time frame: 6 months
Body Mass Index (BMI)
Time frame: 6 months
Need for additional Intra-venous or oral antibiotics
Time frame: 6 months
Treatment quality and satisfaction (TQSM)
Time frame: 6 months
Self reported adherence using "Moriskey Medication Adherence 8" questionnaire (MMAS-8)
Time frame: 6 months
Density of Pseudomonas growth in sputum
Time frame: 6 months
Quality of life measured by CFQ-R
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing in people with Cystic Fibrosis, run by Belfast Health and Social Care Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inhaled Antibiotic collection percentage (time frame: 6 months preceding intervention compared to end of 6 month intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2019.