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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03691324
Other study ID # 2018/753
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 26, 2018
Est. completion date January 15, 2021

Study information

Verified date March 2020
Source Oslo University College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date January 15, 2021
Est. primary completion date November 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Inhalation technique training and discharge service
Patient drug counselling one-to-one, focusing on inhalation drugs and technique

Locations

Country Name City State
Norway Oslo University Hospital Oslo

Sponsors (3)

Lead Sponsor Collaborator
Oslo University College Hospital Pharmacy Enterprise, South Eastern Norway, Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to first readmission Time to readmission based on data from the national patient registry One year after discharge of the last patient
Secondary Improvement in patient reported symptom score (CAT-score) from baseline to 2 months after discharge COPD assessment test (CAT) scores at baseline and 2 months after discharge. 2 months after discharge
Secondary Proportion of patients readmitted 3 months after discharge 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 3 months
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