To investigate whether complex COPD patients are trained in the use of an individualised action plan for self-treatment have fewer COPD exacerbation days over 12 months compared to a control group. Secondary objectives are defined to investigate the…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is the number of COPD exacerbation days (daily
symptom diary).
Secondary outcome
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).
Background summary
COPD is a very common progressive lung condition with distressing exacerbations
that regularly require medical intervention and hospitalisation. Whereas COPD
action plans have now successfully become part of usual care, the plans are
potentially less suitable and possible unsafe to use in the presence of
comborbidities. Therefore, action plans should consider comorbidities. We
hypothesise that this innovative self-treatment strategy will reduce
exacerbation severity and health care costs and improve patient*s health status
by accelerating the initiation of proper treatment actions.
Study objective
To investigate whether complex COPD patients are trained in the use of an
individualised action plan for self-treatment have fewer COPD exacerbation days
over 12 months compared to a control group. Secondary objectives are defined to
investigate the effect of a set of action plans for complex patients on
hospitalisation days for COPD and relevant comorbidities, effects on overall
health care use, (COPD-specific) health status, self-efficacy, the effects on
chronic heart failure exacerbations, level of adherence of intervention
patients, fatigue and anxiety and depression symptoms, satisfaction and
confidence, effects on health care use, and cost-effectiveness of
self-treatment intervention.
Study design
The COPE-III study is an international multicenter randomised controlled trial
in COPD patients with comorbidities, with a 12-month follow-up. Patients will
be randomly assigned to an intervention and a control group. Patients in the
control group will receive usual care. All patients will be educated in
completing their daily symptom diaries during 12 months. Only patients in the
intervention group will participate in four self-management sessions to learn
to work with an individualised action plan that is linked to a daily symptom
diary. During the baseline measurements a 6 Minutes Walking Test and a
spirometry test will be performed in the hospital and questionnaires have to be
completed. The 6-month measurements will be collected via mailed or electronic
questionnaires. In the end, the 12-month measurements will take place in the
hospital where a spirometry test is performed and questionnaires have to be
completed. The risks for patients are negligible and the burden is minimal.
Intervention
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 group sessions guided by
the study nurses. One, four, and eight months after completion of the
self-management discussion sessions, the study nurse will contact the patient
by phone, to reinforce self-management skills.
During the self-management course, patients will learn to treat their COPD
exacerbations and/or flare-ups of comorbidities with the help of an action plan
linked to the diary. The individual action plan shows the actions a patient has
to take with a certain combination of symptoms. It will be repeatedly discussed
with the patients during the sessions.
Besides training in self-treatment, the content and emphasis of the
self-management program will be directed towards mastery of skills necessary
for successful self-management, such as correct medication intake, and the
early recognition of symptoms of an exacerbation of COPD and/or a flare-up of
potential comorbidities.
Study burden and risks
The risks for patients are negligible and the burden is minimal. Patients will
spend time related to the intervention and measurements. The 6 minute walking
test is a regular test in pulmonary medicine, and will lead to increased
brethlessness during the test. This is only transient. Medical treatment of the
patients in this study is no other than in regular care. There is a chance that
the patients who self-treat their symptoms will use more medication then
necessary. However, investigators of a similar study, directed towards
self-treatment in patients with solely COPD, concluded that over-treatment was
not an issue in their study.
Haaksbergerstraat 55
Enschede 7513 ER
NL
Haaksbergerstraat 55
Enschede 7513 ER
NL
Listed location countries
Age
Inclusion criteria
1) a clinical diagnosis of COPD according to the GOLD criteria (FEV1 < 80% of the predicted value and FEV1/FVC<0.70);
2) >= 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
1) terminal cancer or other serious disease with low survival rate;
2) end stage COPD or Chronic Heart Failure (expected survival < 12 months);
3) other serious lung disease (e.g. a1-antitrypsin deficiency; interstitial lung diseases);
4) patients who are currently enrolled in other randomised clinical trials.
5) Mini Mental State Examination score < 24
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | ACTR number: ACTRN12612000514808 |
| CCMO | NL39516.044.12 |