Pulmonary Disease, Chronic ObstructiveNCT03691324
Training of Inhalation Technique in Hospitalized Chronic Obstructive Pulmonary Disease (COPD) Patients - a Pilot Study
A study testing Inhalation technique training and discharge service in people with Pulmonary Disease, Chronic Obstructive, run by Oslo University College at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Inhalation technique training and discharge service
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- 26 Sep 2018to 15 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to the pulmonary ward, the Medical Department, Oslo University Hospital, Oslo, Norway
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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
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
- Being tested
- Inhalation technique training and discharge service
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhalation technique training and discharge serviceOther
Patient drug counselling one-to-one, focusing on inhalation drugs and technique
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Inhalation technique training and discharge service |
| Standard care | No intervention | Patients receive standard care and follow up of their COPD-treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first readmission
Time to readmission based on data from the national patient registry
Measured: 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
COPD assessment test (CAT) scores at baseline and 2 months after discharge.
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start26 Sep 2018
- Primary completion15 Nov 2020
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University College
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, Hospital Pharmacy Enterprise, South Eastern Norway
- Responsible party
- Principal investigator, Liv Mathiesen, Oslo University College
- Investigators
- Liv Mathiesen, PhD, Principal investigator, Oslo University Collage
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691324
- Sponsor's protocol ID
- 2018/753
- Status last verified
- Mar 2020
- First submitted
- 28 Sep 2018
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing of individual patient data is not allowed by the approving authority
Publications
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.
PubMed 35624509
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03691324
- Acronym / sponsor ID
- 2018/753
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Oslo University CollegeUniversity, hospital or other
- Collaborators
- Oslo University Hospital, Hospital Pharmacy Enterprise, South Eastern Norway
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- 15 Nov 2020 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 1 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Inhalation technique training and discharge servicePatients 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. |
| Standard care | No intervention | –Patients receive standard care and follow up of their COPD-treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients admitted to the pulmonary ward, the Medical Department, Oslo University Hospital, Oslo, Norway
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhalation technique training and discharge servicePatient drug counselling one-to-one, focusing on inhalation drugs and technique | Other | Intervention |
Primary outcome
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
2 secondary outcomes
Improvement in patient reported symptom score (CAT-score) from baseline to 2 months after discharge
Time frame: 2 months after discharge
Proportion of patients readmitted 3 months after discharge
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Derived from this study: PubMed 35624509Kebede 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.
- Individual participant dataSharing planned: No. Sharing of individual patient data is not allowed by the approving authority
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liv Mathiesen, PhD principal investigator
Oslo University Collage
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inhalation technique training and discharge service in people with Pulmonary Disease, Chronic Obstructive, run by Oslo University College at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first readmission (time frame: One year after discharge of the last patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03691324, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2021.