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

Not Applicable

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT03691324
• Lead Sponsor: Oslo University College

Brief Summary

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

Not available

Study Timeline

• Study Start: 2018-09-26
• Study First Submitted: 2018-09-28
• Study First Submitted QC: 2018-09-28
• Study First Posted: 2018-10-01
• Status Verified: 2020-03
• Primary Completion: 2020-11-15
• Study Completion: 2021-01-15
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to first readmission	One year after discharge of the last patient	Time to readmission based on data from the national patient registry

Secondary Outcome Measures

Name	Time	Method
Proportion of patients readmitted 3 months after discharge	3 months	Based on the hospital records. Preliminary data to be published in a master thesis, as the data on the primary endpoint will be received too late
Improvement in patient reported symptom score (CAT-score) from baseline to 2 months after discharge	2 months after discharge	COPD assessment test (CAT) scores at baseline and 2 months after discharge.

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway