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

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ClinicalTrials.gov Identifier: NCT03691324
Recruitment Status : Active, not recruiting
First Posted : October 1, 2018
Last Update Posted : March 13, 2019
Sponsor:
Collaborators:
Oslo University Hospital
Hospital Pharmacies Enterprise, South Eastern Norway
Information provided by (Responsible Party):
Liv Mathiesen, 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

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Other: Inhalation technique training and discharge service Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
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
Actual Study Start Date : September 26, 2018
Estimated Primary Completion Date : May 15, 2019
Estimated Study Completion Date : May 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD

Arm Intervention/treatment
Experimental: Intervention Other: Inhalation technique training and discharge service
Patient drug counselling one-to-one, focusing on inhalation drugs and technique

No Intervention: Standard care



Primary Outcome Measures :
  1. 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


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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03691324


Locations
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Norway
Oslo University Hospital
Oslo, Norway, N-0424
Sponsors and Collaborators
Oslo University College
Oslo University Hospital
Hospital Pharmacies Enterprise, South Eastern Norway
Investigators
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Principal Investigator: Liv Mathiesen, PhD Oslo University Collage

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Responsible Party: Liv Mathiesen, Associate professor, Oslo University College
ClinicalTrials.gov Identifier: NCT03691324     History of Changes
Other Study ID Numbers: 2018/753
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Sharing of individual patient data is not allowed by the approving authority

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

Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes