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Completed

NCT Number: NCT03691324

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

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

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, N-0424, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inhalation technique training and discharge service

Other

Patient drug counselling one-to-one, focusing on inhalation drugs and technique

Primary outcomes

  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 outcomes

  1. Improvement in patient reported symptom score (CAT-score) from baseline to 2 months after discharge

    Time frame: 2 months after discharge

    COPD assessment test (CAT) scores at baseline and 2 months after discharge.

  2. Proportion of patients readmitted 3 months after discharge

    Time frame: 3 months

    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

Sponsors and collaborators

Lead sponsor

Oslo University College

Other

Collaborators

  • Hospital Pharmacy Enterprise, South Eastern Norway
  • Oslo University Hospital

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Oct 1, 2018
Registry last updated
Feb 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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