|- candidate number||14699|
|- NTR Number||NTR3945|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||9-apr-2013|
|- Secondary IDs||13-026/C METC UMCU|
|- Public Title||COPD-GRIP study.|
|- Scientific Title||COPD-GRIP study: COPD Guidance, Research on an Illness Perception Intervention.|
|- hypothesis||We hypothesised that:|
1. COPD patients in primary care who received a COPD- illness perception intervention will report a better health status, will have a better Acitvities of Daily Living (ADL), report better Quality of Life and report less burden of diseaset han those who do not receive this intervention;
2. The second aim is to conduct a cost effectiveness analysis of the Ilness perception intervention.
|- Healt Condition(s) or Problem(s) studied||Chronic Obstructive Pulmonary Disease (COPD), Illness perception, Nurse practitioner , First line therapy|
|- Inclusion criteria||1. Spirometrically confirmed diagnosis of COPD GOLD II, III or IV (post-bronchodilatatoir FEV1/FVC < 0.7 and FEV1 (% of predicted) < 80);|
2. Spirometry < one year old;
3. Age >40;
4.Pysically and mentally able to fill in the questionnaires;
5. Patient is competent enough to understand and read the Dutch language.
|- Exclusion criteria||1. COPD GOLD I: FEV1/FVC ratio < 70% and FEV1 (% of predicted) > 80;|
2. age <40 years;
3. Pysically and mentally NOT able to fill in the questionnaires;
4. Patient is NOT competent enough to understand and read the Dutch language;
5. Participating in another study;
6. COPD diagnosis NOT spirometrically confirmed;
7. Primary diagnosis of asthma;
8. Life-threatening co-morbid condition.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2013|
|- planned closingdate||31-dec-2015|
|- Target number of participants||380|
|- Interventions||The COPD Illness Perception Intervention (COPD-IP intervention) is an intervention for COPD patients to be applied by respiratory nurses or practice nurses in a primary care setting and consists of 3 consultations about half hour with an interval of 3 weeks.|
The intervention encompass assessment and interventions tailored to the patientís needs, concerns, and competence.
The control group will receive care as usual.
|- Primary outcome||Health status (measured by the CCQ, Clinical COPD Questionnaire).|
|- Secondary outcome||1. Activities of Daily Living (measured by the FPI Short Form, Functional Performance Inventory Short Form);|
2. Quality of Life (measured by the CRQ-SAS, Chronic Respiratory Disease Questionnaire Self Adminstered Short version;
3. Illness Perception. (Measured by the B-IPQ: Brief Illness Perception Questionnaire);
4. Selfmanagement Competencies (measured by HeiQ Health Education Impact Questionnaire );
5. Disease burden (measured by the new CIS: COPD Impact Scale).
|- Timepoints||1. Baseline;|
2. 6 weeks (direct after completion of the intervention);
3. 3 months post intervention;
4. 9 months post intervention.
|- Trial web site||www.umcutrecht.nl/subsite/griponderzoek|
|- CONTACT FOR PUBLIC QUERIES|| S.W.M. Weldam|
|- CONTACT for SCIENTIFIC QUERIES|| S.W.M. Weldam|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|Picasso voor COPD|
|- Brief summary||COPD is one of the leading causes for morbidity and mortality in the world. COPD-patients face functional decline and limitations in daily life caused by dyspnoea, airflow limitation and skeletal muscle dysfunction. |
Some COPD patients are able to stay active and adhere to the therapeutic regime. They have developed strategies to adapt to their disease, compensate for limitations, and integrate self care activities for managing COPD in their daily life. However, for many COPD patients COPD treatment and staying active is very demanding. Therefore it is important to pay attention to self-management. Based on literature self-management programmes must be improved and amplified with additional behavioral components. Illness perceptions are considered an important factor in this respect. We recently developed a nursing intervention (COPD-IP intervention) focusing on illness perceptions in COPD patients.
The aim of this study is to evaluate this intervention, to be applied by respiratory nurses in a primary care setting. The intervention aims to improve health status, activities of daily living and quality of life of COPD-patients in a primary care setting.
This objective will be addressed in a cluster randomized controlled trial where care as usual will be compared to the COPD-IP intervention. (N=380, 19 clusters in intervention group and 19 clusters in control group), with a follow-up at 6 weeks, 3 months (post intervention) and 9 months (post intervention).
The secondary aim is to conduct a cost effectiveness analysis, alongside the clinical trial, evaluating the socio-economic effects of the intervention compared with usual care given by respiratory nurses in the primary care setting.
|- Main changes (audit trail)|
|- RECORD||9-apr-2013 - 19-apr-2013|