COPD ExacerbationNICCONCT04011332
Nurse-led Integrated Care in COPD Patients With a Pulmonary Exacerbation
A study testing Integrated Care Model in people with COPD Exacerbation, run by University of Zurich at 1 site in Switzerland.
Trial summary
The aim of the study is to evaluate the effect and effectiveness of the nurse-led integrated care programme for the management of COPD (Chronic Obstructive Pulmonary Disease) exacerbations on patients' quality of life, rehospitalisation and exacerbation rate, illness-related emotional distress, selected health… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD Exacerbation
- What is being tested?
- Integrated Care Model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Jul 2019to 30 Apr 2023
- 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 with a confirmed diagnosis of COPD (GOLD 1-4)
- Hospitalisation due to a COPD exacerbation and decision to start with steroids and/or antibiotics (severe exacerbation)
- Age ≥ 18
Who cannot join
- Cognitive impairment (dementia, delirium)
- Not speaking German, French, Italian, English, Spanish, Portuguese, Serbian, Tamil, Hindi, Turkish or Slovakian
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nurse-led Integrated Care to Improve Quality of Life in COPD Patients With a Pulmonary Exacerbation
The aim of the study is to evaluate the effect and effectiveness of the nurse-led integrated care programme for the management of COPD (Chronic Obstructive Pulmonary Disease) exacerbations on patients' quality of life, rehospitalisation and exacerbation rate, illness-related emotional distress, selected health behaviours and cost-utility at three months. Furthermore, understanding barriers and facilitators to implementation success is of interest.
- Conditions
- COPD Exacerbation
- Being tested
- Integrated Care Model
- Keywords
- integrated care, self-management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Care ModelOther
The patients who are hospitalised due to a COPD exacerbation will be aligned to a nurse-led integrated care model for three months. The model constitutes a bundle of interventions that are commonly known as key elements in COPD management. In addition, the ANP-Team (Advanced Nursing Practice-Team) will coordinate the different health professionals within the hospital and across transitions within the three months.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Other: Integrated Care Model |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CRQ (Chronic Respiratory Questionnaire) scores
Change in the four CRQ (Chronic Respiratory Questionnaire) subscores from week 1 to 13. The self-administered questionnaire version with standardised dyspnea questions (SAS) will be used. The questionnaire was developed for patients with chronic airflow limitations and comprises 20 items which assess four domains: 1) dyspnea, 2) fatigue, 3) emotional function and 4) mastery. The scoring scale ranges from 1 (extreme) to 7 (not at all) and will be assessed with a recall period of the past 2 weeks. A subscore for each domain (sum of items / number of items) will be calculated.
Measured: at week one and week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start4 Jul 2019
- Primary completion30 Mar 2023
- Study completion30 Apr 2023
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 COPD ExacerbationStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- monocentric parallel cluster design with a baseline period
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011332
- Sponsor's protocol ID
- 2019-00797
- Other IDs
- 2019
- Acronym
- NICCO
- Status last verified
- May 2023
- First submitted
- 4 Jul 2019
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schmid-Mohler G, Hubsch C, Braun J, Steurer-Stey C, Aregger C, Schaer DJ, Clarenbach C. Effect of a nurse-led integrated care intervention on quality of life and rehospitalisation in patients with severe exacerbation of COPD-a pilot study. Chron Respir Dis. 2024 Jan-Dec;21:14799731241291067. doi: 10.1177/14799731241291067.
PubMed 39407408
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse-led Integrated Care to Improve Quality of Life in COPD Patients With a Pulmonary Exacerbation
- ClinicalTrials.gov ID
- NCT04011332
- Acronym / sponsor ID
- NICCO / 2019-00797
- Conditions
- COPD Exacerbation
- Keywords
- integrated care, self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 4 Jul 2019 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 8 Jul 2019 (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.
The aim of the study is to evaluate the effect and effectiveness of the nurse-led integrated care programme for the management of COPD (Chronic Obstructive Pulmonary Disease) exacerbations on patients' quality of life, rehospitalisation and exacerbation rate, illness-related emotional distress, selected health behaviours and cost-utility at three months. Furthermore, understanding barriers and facilitators to implementation success is of interest.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- monocentric parallel cluster design with a baseline period
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Integrated Care Model |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a confirmed diagnosis of COPD (GOLD 1-4)
- Hospitalisation due to a COPD exacerbation and decision to start with steroids and/or antibiotics (severe exacerbation)
- Age ≥ 18
Key exclusion criteria (2 listed)
- Cognitive impairment (dementia, delirium)
- Not speaking German, French, Italian, English, Spanish, Portuguese, Serbian, Tamil, Hindi, Turkish or Slovakian
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 |
|---|---|---|
| Integrated Care ModelThe patients who are hospitalised due to a COPD exacerbation will be aligned to a nurse-led integrated care model for three months. The model constitutes a bundle of interventions that are commonly known as key elements in COPD management. In addition, the ANP-Team (Advanced Nursing Practice-Team) will coordinate the different health professionals within the hospital and across transitions within the three months. | Other | Intervention Group |
Primary outcome
Change in CRQ (Chronic Respiratory Questionnaire) scores
Time frame: at week one and week 13
Change in the four CRQ (Chronic Respiratory Questionnaire) subscores from week 1 to 13. The self-administered questionnaire version with standardised dyspnea questions (SAS) will be used. The questionnaire was developed for patients with chronic airflow limitations and comprises 20 items which assess four domains: 1) dyspnea, 2) fatigue, 3) emotional function and 4) mastery. The scoring scale ranges from 1 (extreme) to 7 (not at all) and will be assessed with a recall period of the past 2 weeks. A subscore for each domain (sum of items / number of items) will be calculated.
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 11 May 2023.
- Derived from this study: PubMed 39407408Schmid-Mohler G, Hubsch C, Braun J, Steurer-Stey C, Aregger C, Schaer DJ, Clarenbach C. Effect of a nurse-led integrated care intervention on quality of life and rehospitalisation in patients with severe exacerbation of COPD-a pilot study. Chron Respir Dis. 2024 Jan-Dec;21:14799731241291067. doi: 10.1177/14799731241291067.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Care Model in people with COPD Exacerbation, run by University of Zurich at 1 site in Switzerland.
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 3 inclusion and 2 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 11 May 2023. 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 Switzerland. 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?
Change in CRQ (Chronic Respiratory Questionnaire) scores (time frame: at week one and week 13). 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 NCT04011332, 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 11 May 2023.