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

NCT03691324 | Completed

• 1 other identifier: 2018/753
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Time to first readmission

  Time to readmission based on data from the national patient registry

  One year after discharge of the last patient

Secondary Outcomes (2)

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

  2 months after discharge

• Proportion of patients readmitted 3 months after discharge

  3 months

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Other: Inhalation technique training and discharge service

Standard care

NO INTERVENTION

Patients receive standard care and follow up of their COPD-treatment

Interventions

Inhalation technique training and discharge service OTHER

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted to the pulmonary ward, the Medical Department, Oslo University Hospital, Oslo, Norway

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University College: lead
• Oslo University Hospital: collaborator
• Hospital Pharmacy Enterprise, South Eastern Norway: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, N-0424, Norway

Location

Related Publications (1)

• 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.

  PMID: 35624509 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Liv Mathiesen, PhD

  Oslo University Collage

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 1, 2018
• Study Start: September 26, 2018
• Primary Completion: November 15, 2020
• Study Completion: January 15, 2021
• Last Updated: February 25, 2021

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)