RECODE, cluster Randomized clinical trial on Effectiveness of integrated COPD management in primary carE.

• Conditions: Chronic Obstructive Pulmonary DiseaseCOPDPrimary CareIntegrated CareQuality of LifeCost-Effectiveness-AnalysisChronische obstructieve longziektenCOPDHuisartsgeneeskundeGeintegreerde zorgKwaliteit van LevenKosteneffectiviteits analyse

• Registration Number: NL-OMON22200
• Lead Sponsor: eiden University Medical Center

Brief Summary

Hoogendoorn M, van Wetering CR, Schols AM et al. Is INTERdisciplinary COMmunity-based COPD management (INTERCOM) cost-effective? Eur Respir J 2010; 35(1):79-87. <br> Chavannes NH, Grijsen M, van den Akker M et al. Integrated disease management improves one-year quality of life in primary care COPD patients: a controlled clinical trial. Prim Care Respir J 2009; 18(3):171-176.<br> Kruis AL, Chavannes NH. Potential benefits of integrated COPD management in primary care. Monaldi Arch Chest Dis 2010; 73:3, 130-134.<br> Kruis AL, van Adrichem J, Erkelens MR, Scheepers H, in ’t Veen H, Muris JWM, Chavannes NH. Sustained effects of integrated COPD management on health status and exercise capacity in primary care patients. Int J Chron Obstruct Pulmon Dis. 2010; 5, 407-413.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 1080

Inclusion Criteria

Primary care patients with COPD (FEV1/FVC<0.7) according to GOLD and NHG-classification.

Exclusion Criteria

Terminally ill patients and expected non-compliance according to GP.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome of the study is the difference in health status of the participants in the intervention group versus the usual care group after 12 months, as measured with the Clinical COPD Questionnaire (CCQ).

Secondary Outcome Measures

Name	Time	Method
1. Disease-specific quality of life (SGRQ);<br /><br>2. Dyspnoea (MRC dyspnoea scale);<br /><br>3. Quality of life (SF-36, EQ-5D);<br /><br>4. Self-management (SMAS);<br /><br>5. Daily activities (IPAQ);<br /><br>6. Patients' experiences with health care (PACIC);<br /><br>7. Smoking behaviour (packyears, guided cessation attempts);<br /><br>8. Medication use (inhaled corticosteroids and bronchodilators);<br /><br>9. Health care usage;<br /><br>10. Exacerbations (oral prednisolone and/or antibiotic courses);<br /><br>11. Hospital admissions or specialist visits;<br /><br>12. Absence of work;<br /><br>13. Primary care providers’ experience with health care (ACIC)