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Action Plan to enhance self-management and early detection of exacerbations in patients with COPD; a Randomized Controlled Trial

Action Plan to enhance self-management and early detection of exacerbations in patients with COPD; a Randomized Controlled Trial - ACZiE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON32089
Enrollment
180
Registered
2008-10-14
Start date
2008-12-05
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

Chronic Bronchitis Chronic lung disease

Interventions

Patients in the intervention group receive and are taught how to use a written and individualized Action Plan (AP) as an addition to care as usual. This AP provides patients, a invidualized and colo

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Diagnosis of COPD based on post-bronchodilatator FEV1 according to the GOLD standards (=NHG standard). - Diagnosis of COPD as the major functionally limiting disease. - Current use of bronchodilator therapy.

Exclusion criteria

Exclusion criteria: - Primary diagnosis of asthma (onset = 12 % postbronchodilator reversibility in FEV1) - Primary diagnosis of cardiac disease - Primary diagnosis of other functionally limiting disease, that could significantly affect either patient mortality (e.g. malignant neoplasm) or participation in the study (e.g. confusional states, psychoses)

Design outcomes

Primary

MeasureTime frame
- (Clinical COPD Questionnaire) CCQ Symptom recovery time in the event of an exacerbation; number of 3 day CCQ units for the CCQ symptom score to have recovered from the exacerbation onset to the pre-exacerbation 3 unit average.

Secondary

MeasureTime frame
- Treatmet delay (Number of days between exacerbation onset and initiation of treatment; course of antibiotics and/or prednison) - Contact delay (Number of days between exacerbation onset and contacting a health care provider - Health related quality of life I (St.George Respiratory Questionnaire) - Health related quality of life II (number of unfavourable days in 6 months that the Clinical COPD Questionnaire (CCQ) score is >= the individual mean minus 1 standard deviation) - Anxiety (Hospital Anxiety and Depression Scale) - Depression (Hospital Anxiety and Depression Scale) - Symptoms (Medical Research Counsil scale for dyspnea) - Self-efficacy ( exacerbation-related self-efficacy using a self-developped 9-item questionnaire with a 5 point-likert scale. - Healthcare utilization: * time to first respiratory related hospital admissions; number of days between inclusion and first hospital admission * number of respiratory related hospital admissions * proportion of patients having >= 1 respiratory related hospital admission * number of respiratory related hospital days * number of respiratory related emergency room visits (incl. ambulance calls) * number of respiratory related scheduled visits to GP, RN and RP. * number of respiratory related unscheduled visits to GP, RN and RP. * number of telephone calls to GP, RN and RP. * number of courses of oral steroids and/or antibiotics

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)