Back to results

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

About this trial

This is an interventional health services research trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

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

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

We'll reach out to this number within 24 hrs