None listed
Conditions
Brief summary
COPD is a leading cause of death in Australia and its prevalence is increasing globally. The majority of disease burden and costs in COPD are due to treatment of exacerbations, with hospitalisations being the major component. Almost all comorbidities exist more frequently in COPD patients compared to matched elderly populations. One third of COPD patients admitted to hospital have at least four coded comorbidities, and these add to the length of hospital stay. In selected populations of COPD patients, training in the use of COPD action plans reduces COPD exacerbation severity, emergency department visits, hospitalisations and health costs and improves health status. However, overlap in symptoms of COPD and comorbidities complicate the use of COPD action plans in the large group of patients with comorbidities. For example, in a COPD patient with comorbid cardiovascular disease, worsening of his dyspnoea can relate to either disease. Use of only a COPD action plan could lead to incorrect actions and/or delay of proper treatment. We have developed self-treatment training with ongoing nurse support for complex COPD patients. Feedback to patients from nurses is vital to optimize use of action plans. We will enrol 300 COPD patients (150 in each of Australia and the Netherlands) with at least one of the following comorbidity: ischaemic heart disease, heart failure, diabetes, or anxiety/depression. All patients will complete daily symptom diaries for 12 months. Control patients will receive usual care and training in diary completion. Intervention patients will be trained in the use of individualized action plans. We hypothesize that this novel self-treatment strategy will reduce exacerbation severity, hospitalisation stay and costs, and improve quality of life.
Interventions
A COPD self-treatment approach for COPD patients with multiple diseases. The intervention group patients will learn to treat their COPD exacerbations and/or flare-ups of comorbidities with the help of an action plan linked to a daily symptom diary, which they will be asked to complete for a 12-month period. The self-treatment training starts after inclusion and consists of 4 sessions which are guided by the trial nurses: two 2.5-hour group sessions at week 1 and 3 and two individual 1.5-hour ses
A COPD self-treatment approach for COPD patients with multiple diseases. The intervention group patients will learn to treat their COPD exacerbations and/or flare-ups of comorbidities with the help of an action plan linked to a daily symptom diary, which they will be asked to complete for a 12-month period. The self-treatment training starts after inclusion and consists of 4 sessions which are guided by the trial nurses: two 2.5-hour group sessions at week 1 and 3 and two individual 1.5-hour sessions at week 2 and 4. Besides self-treatment, the program will be aimed at knowledge about COPD and comorbidities, immunisations, inhaler techniques, physical fitness, relaxation and breathing exercises. One, four, and eight months after completion of the training, the trial nurse will contact the patient by phone, to reinforce self-management skills. Trial nurse act as case-managers throughout the study.
Sponsors
Repatriation General Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) a clinical diagnosis of COPD according to the GOLD criteria; 2) >= 1 diagnostic comorbidity: ischaemic heart disease (history of myocardial infarction, angina pectoris); heart failure (defined according to the ESC guidelines; diabetes (stable type 1 or 2); or active symptoms of depression and/or anxiety (using cut-off scores from the Hospital Anxiety and Depression Scale (HADS); 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 6 weeks post-hospitalisation or post-rehabilitation); 6) FEV1 < 80% of the predicted value and FEV1/FVC<0.70; 7) able to understand and read the English or Dutch language; 8) written informed consent from the subject prior to participation.
Exclusion criteria
1) terminal cancer or other serious disease with low survival rate; 2) End stage COPD or Chronic Heart Failure (expected survival <12 months) or any other condition which, according to expert clinical judgment of the Chief Investigator, is likely to limit 12-month survival; 3) other serious lung disease (e.g. alpha1-antitrypsin deficiency; interstitial lung diseases); 4) patients with active psychotic symptoms or suicidal ideation; 5) patients with cognitive impairment (Mini-Mental State Exam < 24); 6) patients who are currently enrolled in other clinical trials; 7) currently enrolled in other clinical trials or intensive case-management programs.
Outcome results
None listed