Testing a new approach to supporting people with bronchiectasis to take prescribed inhaled antibiotics

A feasibility study to test an intervention to change adherence to inhaled antibiotics in patients with bronchiectasis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN21712871

Enrollment

Registered

2017-01-05

Start date

2016-07-01

Completion date

Unknown

Last updated

2017-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suboptimal adherence to inhaled antibiotics in bronchiectasis Respiratory Bronchiectasis

Interventions

The CAN-BE intervention is a set of 12 behaviour change techniques that are delivered to patients with bronchiectasis in an attempt to change their adherence to inhaled antibiotics. Behaviour change t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged over 18 years 2. Diagnosed with non-cystic fibrosis bronchiectasis through computed tomography (CT) or high-resolution CT (HRCT) 3. Prescribed inhaled antibiotics (specifically colistimethate sodium) for chronic suppression of P. aeruginosa 4. Have suboptimal adherence

Exclusion criteria

Exclusion criteria: 1. Those who cannot consent to take part or do not have the ability to complete study questionnaires 2. People who self-report full adherence, as measured using a validated self-reported adherence questionnaire

Design outcomes

Primary

Measure	Time frame
Determination of the extent to which the intervention has been delivered as intended, measured by review of completed Participant Intervention Records. For each completed record, the project team will determine the proportion of instructions completed as described in the manual. Errors of omission and deviations to the planned delivery of the intervention will be identified by researcher recall and crosschecked with audio recordings of visits with patients. Reasons for deviations will be discussed with the study team and reported. Measured within one month of intervention delivery.	—

Measure

Time frame

Determination of the extent to which the intervention has been delivered as intended, measured by review of completed Participant Intervention Records. For each completed record, the project team will determine the proportion of instructions completed as described in the manual. Errors of omission and deviations to the planned delivery of the intervention will be identified by researcher recall and crosschecked with audio recordings of visits with patients. Reasons for deviations will be discussed with the study team and reported. Measured within one month of intervention delivery.

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Secondary

Measure	Time frame
1. Percentage fidelity to the planned delivery of behaviour change techniques. A coding frame will be used to describe when and how each technique should be delivered. A health psychologist, independent of the research team, will review anonymised transcripts of audio recordings of consultations and will use the coding frame to record whether the component has been delivered. Percentage fidelity will be determined by dividing the number of techniques recorded as delivered by the reviewer by the number of techniques the researcher recorded as delivered in the Participant Intervention Record, multiplied by 100. Measured within three months of intervention delivery. 2. Participant feedback about the intervention. The researcher will interview participants after they have received the full intervention to gather feedback about the intervention and usability of the intervention materials. Measured at two weeks after intervention delivery. 3. Feasibility of recruitment strategy in target population. Information about the recruitment process will be recorded on a pre-screening log (to assess eligibility) and a recruitment log, and will include the number of individuals retained at each stage of the recruitment process. Measured at three months after intervention delivery. 4. Suitability of methods used to measure participants’ adherence to colistimethate sodium before and after receiving the intervention. The 8-item Morisky’s Medication Adherence Scale (MMAS-8) questionnaire will be used to measure adherence to colistimethate sodium at baseline and three months after Visit 3. Medication possession ratio (MPR) will be used as a second measure of adherence to colistimethate sodium at baseline and three months after Visit 3. Measured at baseline and 3 months after intervention delivery. 5. Suitability of methods used to measure quality-of-life before and after receiving the intervention. The Quality of Life-Bronchiectasis questionnaire Version 3.1 will be self-completed by	—

Measure

Time frame

1. Percentage fidelity to the planned delivery of behaviour change techniques. A coding frame will be used to describe when and how each technique should be delivered. A health psychologist, independent of the research team, will review anonymised transcripts of audio recordings of consultations and will use the coding frame to record whether the component has been delivered. Percentage fidelity will be determined by dividing the number of techniques recorded as delivered by the reviewer by the number of techniques the researcher recorded as delivered in the Participant Intervention Record, multiplied by 100. Measured within three months of intervention delivery. 2. Participant feedback about the intervention. The researcher will interview participants after they have received the full intervention to gather feedback about the intervention and usability of the intervention materials. Measured at two weeks after intervention delivery. 3. Feasibility of recruitment strategy in target population. Information about the recruitment process will be recorded on a pre-screening log (to assess eligibility) and a recruitment log, and will include the number of individuals retained at each stage of the recruitment process. Measured at three months after intervention delivery. 4. Suitability of methods used to measure participants’ adherence to colistimethate sodium before and after receiving the intervention. The 8-item Morisky’s Medication Adherence Scale (MMAS-8) questionnaire will be used to measure adherence to colistimethate sodium at baseline and three months after Visit 3. Medication possession ratio (MPR) will be used as a second measure of adherence to colistimethate sodium at baseline and three months after Visit 3. Measured at baseline and 3 months after intervention delivery. 5. Suitability of methods used to measure quality-of-life before and after receiving the intervention. The Quality of Life-Bronchiectasis questionnaire Version 3.1 will be self-completed by

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026