Chronic Obstructive Pulmonary DiseaseACZiENCT00879281
Action Plan to Enhance Self-management and Early Detection of Exacerbations in Chronic Obstructive Pulmonary Disease (COPD) Patients
A study testing Action plan in people with Chronic Obstructive Pulmonary Disease, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
The purpose of this randomized controlled trial is to evaluate the hypothesis that the 'written' action plan, a self-management tool developed by the project group, enhances early detection and prompt action measures and consequently isbeneficial in exacerbation outcome (i.e., health status recovery time). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Action plan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2008to Dec 2010
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- post-bronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) ratio < 70%
- age > 40 years
- complaints of chronic cough
- smoking history of more than 20 years or 15 pack-years
- diagnosis of COPD as major functionally limiting disease and
- current use of bronchodilator therapy.
Who cannot join
- primary diagnosis of asthma
- primary diagnosis of cardiac disease
- presence of disease that could either effect mortality or participation in the study (e.g. confusional states).
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht
Utrecht, Utrecht, 3584 CX
About this study
Official title: Action Plan to Enhance Self-management and Early Detection of Exacerbations in COPD Patients; A Multicenter RCT (ACZiE)
The purpose of this randomized controlled trial is to evaluate the hypothesis that the 'written' action plan, a self-management tool developed by the project group, enhances early detection and prompt action measures and consequently isbeneficial in exacerbation outcome (i.e., health status recovery time).
Read the detailed description
Early detection of exacerbations by COPD patients initiating prompt interventions has shown to be clinically relevant. Until now, research failed to identify the effectiveness of a written individualized Action Plan (AP) to achieve this. The current multicenter, single-blind RCT with a follow-up period of 6 months, evaluates the hypothesis that individualized AP's reduce exacerbation recovery time. Patients are included from regular respiratory nurse visits and allocated to either usual care or an additional AP providing individualized treatment prescriptions (pharmaceutical and non-pharmaceutical) related to a colour coded symptom status (reinforcement at 1 and 4 months). Although usually not possible in self-management trials, we ensured blinding of patients, using a modified informed consent procedure in which patients give consent to postponed information. Exacerbations in both study arms are defined using the Anthonisen symptom diary-card algorithm. The Clinical COPD Questionnaire (CCQ) is assessed every 3-days. CCQ-recovery time of an exacerbation is our primary outcome. Additionally, healthcare utilisation, anxiety, depression, treatment delay, and self-efficacy are assessed at baseline, 6 and 12 months.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Action plan
- Keywords
- COPD, emphysema, chronic bronchitis
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema, Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action planBehavioural
Individualized "written" Action Plan to enhance self-management and early detection of an exacerbation.
| Study group | Role | What they receive |
|---|---|---|
| 1 Care as usual | No intervention | Regular care |
| 2 Intervention | Experimental | Regular Care + individualized "written" action plan to enhance self-mananagement and early detection/treatment of an exacerbation. Receives: Behavioral: Action plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
CCQ-recovery time in the event of an exacerbation(Health status recovery time)
Measured: 6-months
Secondary outcomes (8)
Symptom recovery time in the event of an exacerbation
Measured: 6 months
Health Related Quality of Life - St George Respiratory Questionnaire
Measured: baseline and 6 months follow-up
The Hospital Anxiety and Depression Scale (HADS)
Measured: baseline and 6 months follow-up
Medical Research Council (MRC) Dyspnoea Scale
Measured: baseline and 6 months follow-up
Julius Self-Efficacy Scale
Measured: baseline and 6 months follow-up
Contact delay & treatment delay in the event of an exacerbation
Measured: 6 months
Exacerbation rates (Number of symptom-based / event-based exacerbations per patient year)
Measured: 6 months
Healthcare Utilization (The number of respiratory-related hospital admissions, hospital days, emergency room visits and scheduled and unscheduled visits or telephone calls to a RP and GP)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2009 (estimated)
- Study startDec 2008
- Primary completionSep 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Investigators
- Jaap C.A. Trappenburg, MSc, Principal investigator, University Medical Center Utrecht, The NetherlandsGerdien D. de Weert - van Oene, PhD, Study chair, University Medical Center Utrecht, The NetherlandsEvelyn M. Monninkhof, PhD, Study chair, University Medical Center Utrecht, The NetherlandsThierry Troosters, PhD, Study chair, KU LeuvenJean Bourbeau, PhD, Study chair, McGill University, Montreal Chest Institute, CanadaTheo J.M. Verheij, PhD, Study director, University Medical Center Utrecht, The NetherlandsJan-Willem J. Lammers, PhD, Study director, University Medical Center Utrecht, The NetherlandsGuus J.P. Schrijvers, PhD, Study director, University Medical Center Utrecht, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00879281
- Sponsor's protocol ID
- OND1333118
- Acronym
- ACZiE
- Status last verified
- Apr 2009
- First submitted
- 8 Apr 2009
- Last updated
- 24 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Turnock AC, Walters EH, Walters JA, Wood-Baker R. Action plans for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2005 Oct 19;(4):CD005074. doi: 10.1002/14651858.CD005074.pub2.
PubMed 16235392Effing T, Monninkhof EM, van der Valk PD, van der Palen J, van Herwaarden CL, Partidge MR, Walters EH, Zielhuis GA. Self-management education for patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD002990. doi: 10.1002/14651858.CD002990.pub2.
PubMed 17943778Trappenburg JC, Koevoets L, de Weert-van Oene GH, Monninkhof EM, Bourbeau J, Troosters T, Verheij TJ, Lammers JW, Schrijvers AJ. Action Plan to enhance self-management and early detection of exacerbations in COPD patients; a multicenter RCT. BMC Pulm Med. 2009 Dec 29;9:52. doi: 10.1186/1471-2466-9-52.
PubMed 20040088
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Action Plan to Enhance Self-management and Early Detection of Exacerbations in COPD Patients; A Multicenter RCT (ACZiE)
- ClinicalTrials.gov ID
- NCT00879281
- Acronym / sponsor ID
- ACZiE / OND1333118
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, emphysema, chronic bronchitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 9 Apr 2009 (estimated)
- 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 purpose of this randomized controlled trial is to evaluate the hypothesis that the 'written' action plan, a self-management tool developed by the project group, enhances early detection and prompt action measures and consequently isbeneficial in exacerbation outcome (i.e., health status recovery time).
Detailed description
Early detection of exacerbations by COPD patients initiating prompt interventions has shown to be clinically relevant. Until now, research failed to identify the effectiveness of a written individualized Action Plan (AP) to achieve this. The current multicenter, single-blind RCT with a follow-up period of 6 months, evaluates the hypothesis that individualized AP's reduce exacerbation recovery time. Patients are included from regular respiratory nurse visits and allocated to either usual care or an additional AP providing individualized treatment prescriptions (pharmaceutical and non-pharmaceutical) related to a colour coded symptom status (reinforcement at 1 and 4 months). Although usually not possible in self-management trials, we ensured blinding of patients, using a modified informed consent procedure in which patients give consent to postponed information. Exacerbations in both study arms are defined using the Anthonisen symptom diary-card algorithm. The Clinical COPD Questionnaire (CCQ) is assessed every 3-days. CCQ-recovery time of an exacerbation is our primary outcome. Additionally, healthcare utilisation, anxiety, depression, treatment delay, and self-efficacy are assessed at baseline, 6 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Care as usual | No intervention | –Regular care |
| 2 Intervention | Experimental | Behavioral: Action planRegular Care + individualized "written" action plan to enhance self-mananagement and early detection/treatment of an exacerbation. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- post-bronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) ratio < 70%
- age > 40 years
- complaints of chronic cough
- smoking history of more than 20 years or 15 pack-years
- diagnosis of COPD as major functionally limiting disease and
Key exclusion criteria (3 listed)
- primary diagnosis of asthma
- primary diagnosis of cardiac disease
- presence of disease that could either effect mortality or participation in the study (e.g. confusional states).
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 |
|---|---|---|
| Action planIndividualized "written" Action Plan to enhance self-management and early detection of an exacerbation. | Behavioural | 2 Intervention |
Primary outcome
CCQ-recovery time in the event of an exacerbation(Health status recovery time)
Time frame: 6-months
8 secondary outcomes
Symptom recovery time in the event of an exacerbation
Time frame: 6 months
Health Related Quality of Life - St George Respiratory Questionnaire
Time frame: baseline and 6 months follow-up
The Hospital Anxiety and Depression Scale (HADS)
Time frame: baseline and 6 months follow-up
Medical Research Council (MRC) Dyspnoea Scale
Time frame: baseline and 6 months follow-up
Julius Self-Efficacy Scale
Time frame: baseline and 6 months follow-up
Contact delay & treatment delay in the event of an exacerbation
Time frame: 6 months
Exacerbation rates (Number of symptom-based / event-based exacerbations per patient year)
Time frame: 6 months
Healthcare Utilization (The number of respiratory-related hospital admissions, hospital days, emergency room visits and scheduled and unscheduled visits or telephone calls to a RP and GP)
Time frame: 6 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 24 Feb 2011.
- Background: PubMed 16235392Turnock AC, Walters EH, Walters JA, Wood-Baker R. Action plans for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2005 Oct 19;(4):CD005074. doi: 10.1002/14651858.CD005074.pub2.
- Background: PubMed 17943778Effing T, Monninkhof EM, van der Valk PD, van der Palen J, van Herwaarden CL, Partidge MR, Walters EH, Zielhuis GA. Self-management education for patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD002990. doi: 10.1002/14651858.CD002990.pub2.
- Derived from this study: PubMed 20040088Trappenburg JC, Koevoets L, de Weert-van Oene GH, Monninkhof EM, Bourbeau J, Troosters T, Verheij TJ, Lammers JW, Schrijvers AJ. Action Plan to enhance self-management and early detection of exacerbations in COPD patients; a multicenter RCT. BMC Pulm Med. 2009 Dec 29;9:52. doi: 10.1186/1471-2466-9-52.
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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.
Jaap C.A. Trappenburg, MSc principal investigator
University Medical Center Utrecht, The Netherlands
Gerdien D. de Weert - van Oene, PhD study chair
University Medical Center Utrecht, The Netherlands
Evelyn M. Monninkhof, PhD study chair
University Medical Center Utrecht, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Action plan in people with Chronic Obstructive Pulmonary Disease, run by UMC Utrecht at 1 site in Netherlands.
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 6 inclusion and 3 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 24 Feb 2011. 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 Netherlands. 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?
CCQ-recovery time in the event of an exacerbation(Health status recovery time) (time frame: 6-months). 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 NCT00879281, which also lists 3 linked publications.
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 24 Feb 2011.