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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Liv Mathiesen，Oslo University College

Tracking Information

First Submitted Date ^ICMJE

September 28, 2018

First Posted Date ^ICMJE

October 1, 2018

Last Update Posted Date

October 1, 2018

Actual Study Start Date ^ICMJE

October 1, 2018

Estimated Primary Completion Date

May 15, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Time to first readmission[ Time Frame: One year after discharge of the last patient ]

Time to readmission based on data from the national patient registry

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Improvement in patient reported symptom score (CAT-score) from baseline to 4 weeks after discharge[ Time Frame: Four weeks after discharge ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Health Services Research

Condition ^ICMJE

Intervention ^ICMJE

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

Study Arms

Experimental: Intervention
No Intervention: Standard care

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

May 15, 2020

Estimated Primary Completion Date

May 15, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Norway

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Liv Mathiesen，Oslo University College

Study Sponsor ^ICMJE

Oslo University College

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Liv Mathiesen, PhD Oslo University Collage

PRS Account

Oslo University College

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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