Training of Inhalation Technique in Hospitalized Chronic Obstructive Pulmonary Disease (COPD) Patients - a Pilot Study
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Inhalation technique training and discharge service
Sponsored by
About this trial
This is an interventional health services research trial for Pulmonary Disease, Chronic Obstructive
Eligibility Criteria
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
Sites / Locations
- Oslo University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Standard care
Arm Description
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.
Patients receive standard care and follow up of their COPD-treatment
Outcomes
Primary Outcome Measures
Time to first readmission
Time to readmission based on data from the national patient registry
Secondary Outcome Measures
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.
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
Full Information
NCT ID
NCT03691324
First Posted
September 28, 2018
Last Updated
February 23, 2021
Sponsor
Oslo University College
Collaborators
Oslo University Hospital, Hospital Pharmacy Enterprise, South Eastern Norway
1. Study Identification
Unique Protocol Identification Number
NCT03691324
Brief Title
Training of Inhalation Technique in Hospitalized Chronic Obstructive Pulmonary Disease (COPD) Patients - a Pilot Study
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 26, 2018 (Actual)
Primary Completion Date
November 15, 2020 (Actual)
Study Completion Date
January 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University College
Collaborators
Oslo University Hospital, Hospital Pharmacy Enterprise, South Eastern Norway
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Patients receive standard care and follow up of their COPD-treatment
Intervention Type
Other
Intervention Name(s)
Inhalation technique training and discharge service
Intervention Description
Patient drug counselling one-to-one, focusing on inhalation drugs and technique
Primary Outcome Measure Information:
Title
Time to first readmission
Description
Time to readmission based on data from the national patient registry
Time Frame
One year after discharge of the last patient
Secondary Outcome Measure Information:
Title
Improvement in patient reported symptom score (CAT-score) from baseline to 2 months after discharge
Description
COPD assessment test (CAT) scores at baseline and 2 months after discharge.
Time Frame
2 months after discharge
Title
Proportion of patients readmitted 3 months after discharge
Description
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
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liv Mathiesen, PhD
Organizational Affiliation
Oslo University Collage
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
N-0424
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Sharing of individual patient data is not allowed by the approving authority
Citations:
PubMed Identifier
35624509
Citation
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.
Results Reference
derived
Learn more about this trial
Training of Inhalation Technique in Hospitalized Chronic Obstructive Pulmonary Disease (COPD) Patients - a Pilot Study
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