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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Could Training in Inhalation Technique During the Hospital Stay and Discharge Services From the Pharmacy Reduce the Rate of Readmissions for COPD Patients? - A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03691324
• Other study ID #: 2018/753
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

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