Teaching Inhaler Use With the INCA Device in a Community Pharmacy Setting

NCT ID: NCT02203266

Last Updated: 2019-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2017-01-31

Brief Summary

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The purpose of this trial is to discover whether providing feedback to patients from a device that records when and how well a patient uses a Seretide Diskus inhaler will lead to:

* Improved compliance with prescribed inhaler use
* Improved technique of inhaler use
* A reduction in respiratory health related outcomes caused by poor inhaler compliance and usage.
* An improvement in patient quality of life scores

Detailed Description

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Conditions

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Asthma Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Feedback

Feedback on the patient's own inhaler use, with personalized information on the patients technique and timing of use of the diskus inhaler as recorded on the INCA device will be provided to patients in the feedback group after 1,2 and 6 months.

Group Type EXPERIMENTAL

Feedback

Intervention Type DEVICE

Feedback on the patient's own inhaler use, with personalized information on the patients technique and timing of use of the diskus inhaler as recorded on the INCA device will be provided to patients in the feedback group after 1,2 and 6 months.

Demonstration

Current best practice - inhaler technique education

Group Type ACTIVE_COMPARATOR

Education

Intervention Type BEHAVIORAL

Feedback on the patient's own inhaler technique as observed by pharmacist and education to support best use will be provided to patients in the demonstration group after 1,2 and 6 months.

Control

Usual care in the community pharmacy setting

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Feedback

Feedback on the patient's own inhaler use, with personalized information on the patients technique and timing of use of the diskus inhaler as recorded on the INCA device will be provided to patients in the feedback group after 1,2 and 6 months.

Intervention Type DEVICE

Education

Feedback on the patient's own inhaler technique as observed by pharmacist and education to support best use will be provided to patients in the demonstration group after 1,2 and 6 months.

Intervention Type BEHAVIORAL

Other Intervention Names

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INCA Device

Eligibility Criteria

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Inclusion Criteria

* Must be 18 years old or above
* Capable of understanding and willing to provide voluntary informed consent before any protocol specific procedures are performed
* Capable of understanding and complying with the requirements of the protocol, and demonstrating a willingness to attend for all required visits.
* Able and willing to take inhaled medication.
* Have a valid prescription for use of a Seretide diskus inhaler or already using a Seretide diskus inhaler.
* Have a history of regular attendance in the pharmacy in which they are recruited which will be demonstrated by the subject having collected three prescriptions for any medication in that pharmacy in the six months preceeding their recruitment to the study.

Exclusion Criteria

* Patient expressly reports that their physician has indicated that they will not be continuing to receive Seretide over the next 6 months
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Royal College of Surgeons, Ireland

OTHER

Sponsor Role collaborator

Beaumont Hospital

OTHER

Sponsor Role lead

Responsible Party

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Professor Richard Costello

Professor Richard Costello

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard Costello, Professor

Role: PRINCIPAL_INVESTIGATOR

Royal College of Surgeons in Ireland, Clinical Research Centre, Beaumont Hospital

Locations

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Boots Retail (Ireland) Limited

Dublin, , Ireland

Site Status

Countries

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Ireland

References

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O'Dwyer SM, MacHale E, Sulaiman I, Holmes M, Hughes C, D'Arcy S, Rapcan V, Taylor T, Boland F, Bosnic-Anticevich S, Reilly RB, Ryder SA, Costello RW. The effect of providing feedback on inhaler technique and adherence from an electronic audio recording device, INCA(R), in a community pharmacy setting: study protocol for a randomised controlled trial. Trials. 2016 May 4;17(1):226. doi: 10.1186/s13063-016-1362-9.

Reference Type DERIVED
PMID: 27142873 (View on PubMed)

Other Identifiers

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RC004

Identifier Type: -

Identifier Source: org_study_id

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