The effects of self-treatment on duration of exacerbations, health status and costs of health care in patients with Chronic Obstructive Pulmonary Disease (COPD) and common co-morbidities.

The effects of self-treatment on duration of exacerbations, health status and costs of health care in patients with Chronic Obstructive Pulmonary Disease (COPD) and common co-morbidities. - COPE-III

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39810

Enrollment

140

Registered

2012-04-03

Start date

2012-06-06

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Intervention: self-management of COPD patients with comorbidities. Patients will be randomised to receive the intervention will attend two individual one-hour sessions and two or three 2.0-hour gro

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) a clinical diagnosis of COPD according to the GOLD criteria (FEV1 = 1 diagnostic comorbidity: ischaemic heart disease (history of myocardial infarction, angina pectoris (stable or unstable); heart failure (defined according to the ESC guidelines); diabetes (steroid-induced or stable diabetes type 1 or 2); or active symptoms of depression and/or anxiety (AD) (using a cut-off score of >= 11 from the Hospital Anxiety and Depression Scale) (HADS) and/or having AD symptoms that are currently being treated; 3) >= 3 exacerbations, defined as respiratory problems that required a course of oral corticosteroids / antibiotics in the two years preceding study entry; and/or >= 1 hospitalisation for respiratory problems in the two years preceding study entry; and/or Modified MRC (mMRC) score of 3 or 4; 4) >= 40 years of age; 5) stable at the time of inclusion (at least 4 weeks post-exacerbation, 6 weeks post-hospitalisation or post-rehabilitation); 6) able to understand and read the Dutch language; 7) written informed consent from the subject prior to participation.

Exclusion criteria

Exclusion criteria: 1) terminal cancer or other serious disease with low survival rate; 2) end stage COPD or Chronic Heart Failure (expected survival

Design outcomes

Primary

Measure	Time frame
The primary outcome measure is the number of COPD exacerbation days (daily symptom diary).	—

Secondary

Measure	Time frame
Secondary outcome measures are health status (spirometry (FEV1, FVC); Health-Related Quality of Life (SF-12, Chronic Respiratory Questionnaire); subjective fatigue (Fatigue Score); anxiety and depression symptoms (HADS)), confidence and competence (COPD Self-Efficacy Scale); adherence of patients with self-treatment protocol (daily symptom diary); satisfaction and confidence of health care providers (semi-structured interviews) and patients (focusgroups); and cost data (cost-effectiveness analysis).	—

Measure

Time frame

Secondary outcome measures are health status (spirometry (FEV1, FVC); Health-Related Quality of Life (SF-12, Chronic Respiratory Questionnaire); subjective fatigue (Fatigue Score); anxiety and depression symptoms (HADS)), confidence and competence (COPD Self-Efficacy Scale); adherence of patients with self-treatment protocol (daily symptom diary); satisfaction and confidence of health care providers (semi-structured interviews) and patients (focusgroups); and cost data (cost-effectiveness analysis).

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)