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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34790

Enrollment

1080

Registered

2010-06-03

Start date

2010-06-03

Completion date

Unknown

Last updated

2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic bronchitis COPD emphysema

Interventions

The intervention consists of the aforementioned multidisciplinary course, clinical and logistical feedback and support of implementation of an ICT-based web application. During this course, Dutch pr

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: COPD (FEV1/FVC

Exclusion criteria

Exclusion criteria: terminally ill patients and (hard drugs) substance abusers

Design outcomes

Primary

Measure	Time frame
The primary outcome of this study is the difference in severity of respiratory symptoms as measured by Clinical COPD Questionnaire (CCQ) at baseline and after 12 months between patients in the intervention practices and patients in the usual care practices. The CCQ is well-validated, easily applied in primary care and sufficiently sensitive to change. The power calculation has been based on a validated clinically relevant difference of 0.4pts on the CCQ.	—

Measure

Time frame

The primary outcome of this study is the difference in severity of respiratory symptoms as measured by Clinical COPD Questionnaire (CCQ) at baseline and after 12 months between patients in the intervention practices and patients in the usual care practices. The CCQ is well-validated, easily applied in primary care and sufficiently sensitive to change. The power calculation has been based on a validated clinically relevant difference of 0.4pts on the CCQ.

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Secondary

Measure	Time frame
Secondary outcomes are differences in: Secondary outcome measures (at 6, 9, 12, 18, 24 months) are differences in: -disease-specific quality of life (SGRQ-C) -dyspnoea (MRC dyspnoea scale) -patients* experiences (CQ-index) -utility (EQ-5D and SF-36) -self management skills (SMAS) -daily activities (IPAQ) -health care use -absence from paid work -exercise tolerance (6MWD) -medication use (inhaled corticosteroids and bronchodilators) -exacerbations (oral prednisolone and/or antibiotic courses) -hospital admissions -lung function measurements (FEV1 absolute and predicted, FEV1/FVC) -smoking behavior (pack years, guided cessation attempts) -body mass index (BMI) -experiences of health care workers (ACIC)	—

Measure

Time frame

Secondary outcomes are differences in: Secondary outcome measures (at 6, 9, 12, 18, 24 months) are differences in: -disease-specific quality of life (SGRQ-C) -dyspnoea (MRC dyspnoea scale) -patients* experiences (CQ-index) -utility (EQ-5D and SF-36) -self management skills (SMAS) -daily activities (IPAQ) -health care use -absence from paid work -exercise tolerance (6MWD) -medication use (inhaled corticosteroids and bronchodilators) -exacerbations (oral prednisolone and/or antibiotic courses) -hospital admissions -lung function measurements (FEV1 absolute and predicted, FEV1/FVC) -smoking behavior (pack years, guided cessation attempts) -body mass index (BMI) -experiences of health care workers (ACIC)

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)