Training of Inhalation Technique in Hospitalized Chronic Obstructive Pulmonary Disease (COPD) Patients - a Pilot Study

NCT ID: NCT03691324

Last Updated: 2021-02-25

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-26

Study Completion Date

2021-01-15

Brief Summary

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Inhalation drugs are essential in the treatment of COPD, in controlling symptoms and preventing exacerbations. The aim of this pilot study is to collect data necessary for the planning of future efficacy trials. We plan to assess the value of providing training in inhalation technique to hospitalized COPD patients. Data on rehospitalizations will be collected from the hospital's medical records and from the National Patient Registry . The inhalation technique of all recruited patients will de assessed at baseline. The patients will then be randomised 1:1 to the intervention or standard care group. The intervention consists of a drug counselling, focusing on inhalation technique. In addition patients in the intervention group will have their medicines personally delivered from the hospital pharmacy at discharge (discharge service). Patients will be asked to fill in questionnaires evaluating the inhalation training and the discharge service

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention

Patients receive an inhalation technique education based on standardized procedure developed by The Norwegian Pharmacy Association. In addition they are offered a discharge service day before or the day of discharge; a second inhalation training and dispensing of their prescribed COPD- medicines.

Group Type EXPERIMENTAL

Inhalation technique training and discharge service

Intervention Type OTHER

Patient drug counselling one-to-one, focusing on inhalation drugs and technique

Standard care

Patients receive standard care and follow up of their COPD-treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Inhalation technique training and discharge service

Patient drug counselling one-to-one, focusing on inhalation drugs and technique

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients admitted to the pulmonary ward, the Medical Department, Oslo University Hospital, Oslo, Norway

Exclusion Criteria

Patients

* previously included to the study
* usually not administering their inhalation drugs themselves
* using nebulizer chamber with their drug
* who are contagious, thus restricting accessibility of personnel
* who are not able to provide informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role collaborator

Hospital Pharmacy Enterprise, South Eastern Norway

OTHER

Sponsor Role collaborator

Oslo University College

OTHER

Sponsor Role lead

Responsible Party

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Liv Mathiesen

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Liv Mathiesen, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Collage

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

References

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Kebede AT, Trapnes E, Lea M, Abrahamsen B, Mathiesen L. Effect of pharmacist-led inhaler technique assessment service on readmissions in hospitalized COPD patients: a randomized, controlled pilot study. BMC Pulm Med. 2022 May 27;22(1):210. doi: 10.1186/s12890-022-02004-z.

Reference Type DERIVED
PMID: 35624509 (View on PubMed)

Other Identifiers

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2018/753

Identifier Type: -

Identifier Source: org_study_id

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