|- candidate number||14192|
|- NTR Number||NTR3788|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-jan-2013|
|- Secondary IDs||12-N-93 METC Atrium Orbis Zuyd|
|- Public Title||The development and evaluation of a new burden of disease instrument for COPD.|
|- Scientific Title||The development and evaluation of a new burden of disease instrument for COPD. The COPD Impact Scale.|
|- hypothesis||COPD management using the COPD Impact Scale and an treatment algoritm, will be more effective in improving the health related quality of life of COPD patients, meausured by the Saint George Respiratory Questionnaire, than usual care, over a period of 18 months. |
|- Healt Condition(s) or Problem(s) studied||Chronic Obstructive Pulmonary Disease (COPD)|
|- Inclusion criteria||1. Spirometrically confirmed diagnosis of COPD (post-bronchodilatatoir FEV1/FVC < 0.7);|
2. Age 40+;
3. Patient is competent enough to understand and read the Dutch language.
|- Exclusion criteria||1. Exacerbations < 6 weeks;|
2. Hard drug addiction;
3. Life-threatening co-morbid condition;
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2013|
|- planned closingdate||1-feb-2015|
|- Target number of participants||360|
|- Interventions||Participants in the intervention group will receive treatment, based on the newly developed COPD Impact Scale (CIS) and a treatment-algorithm. Patients will fill out the CIS, and additionally the caregiver will add some more relevant parameters. A computer based algorithm will visually display the outcomes and provides advices the patients and caregivers can discuss and put in the treatment plan.
Participants in the control group will receive care as usual.
|- Primary outcome||The difference in health-related quality of life between baseline and 18-months follow-up, measured by the St George’s Respiratory Questionnaire. |
|- Secondary outcome||1. The difference in health-related quality of life between baseline and 6-months and 12-months follow-up, measured by the St George’s Respiratory Questionnaire;|
2. The difference in health-related quality of life between baseline and 18-months follow-up, measured by the COPD Assessment Test;
3. Differences will be calculated between baseline and 18-months follow up on the EuroQol 5d;
4. Number of exacerbations at 12 months and 18 months.
|- Timepoints||1. Baseline;|
2. 6 months follow up;
3. 12 months follow up;
4. 18 monhts follow up.
|- Trial web site||www.ziektelastmetercopd.nl|
|- CONTACT FOR PUBLIC QUERIES||MSc. Annerika Slok|
|- CONTACT for SCIENTIFIC QUERIES||MSc. Annerika Slok|
|- Sponsor/Initiator ||CAPHRI, The Research Institute of the University Maastricht and University Hospital Maastricht (AZM)|
(Source(s) of Monetary or Material Support)
|Achmea, Astra Zeneca, GSK BIO, Belgium, Novartis, Picasso voor COPD, Boehringer Ingelheim|
|- Brief summary||Chronic Obstructive Pulmonary Disease (COPD) is an irreversible lung disease and an increasing health problem worldwide. On the basis of morbidity records of general practices, the number of COPD patients know by the GPs can be estimated. Each year two new COPD patients are found per 1000 patients who are registered, while there are already 20 patients being treated for COPD amongst this 1000 patients.
COPD imposes a great burden on patients. It is a major cause of morbidity and mortality. Many patients suffer from it for years, and die prematurely due to complications arising from the disease. Approximately 6000 people die every year due to COPD. It is expected that prevalence of COPD will increase with 76% within approximately twenty years. |
As COPD cannot be cured, it is important to focus on patient-reported outcomes, to address the progression of disease, complaints, limitations, and quality of life, in order to provide optimal treatment.
In order to improve health care in the Netherlands, Health Care Standards are developed. Health Care Standards offer a functional description of the multidisciplinary organization of prevention, care, and self-management support for a chronic condition from a patient perspective, during the full continuum of care. These are based on actual and, as far as possible, scientifically- funded insights. The ‘Dutch Health Care Standard COPD’ describes a new concept, namely the "burden of disease". The burden of COPD is considered to be attributed to more than simply the airway obstruction: it is defined by a Dutch national expert research team, commissioned by the Dutch Lung Alliance (Long Alliantie Nederland; LAN), as: “The physical, psychological, emotional and/or social burden as experienced by the patient.”
This new concept is intended to guide management of COPD patients and can also classify the patients’ burden of disease as a mild, moderate or severe burden of disease.
Therefore, the Dutch national expert research team created the COPD Impact Scale (CIS) using literature and input from both patients and health care professionals. Furthermore an algorithm was written that includes instructions and advices to assist the health care professional in providing the patient with the care they need.
This study aims to assess the effectiveness of the CIS in the management of patients with COPD.
This study is a 2-armed, cluster randomized controlled trial (RCT) comparing an intervention group using the CIS and algorithm-based COPD management, to a control group receiving usual care.
The duration of the follow-up period is 18 months. During the first part of the study the intervention arm will also deliver data on the reproducibility and validity of the COPD Impact Scale (CIS).
The trial will be conducted amongst General Practitioners and pulmonologist throughout the Netherlands.
|- Main changes (audit trail)|
|- RECORD||11-jan-2013 - 20-jan-2013|