Primary Objective: To evaluate the effectiveness of an individualized AP (initiating early detection of exacerbations and prompt intervention) on recovery of symptom-based Quality of life in the event of an exacerbation. Secondary Objective(s): To…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- (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 outcome
- 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
Background summary
Exacerbations of COPD have large impact on Health Related Quality of Life
(HRQoL), mortality and lung function decline. Early detection of changing
symptoms/signs and exacerbations by COPD patients initiating prompt
interventions has shown to be clinically relevant. Until now, research failed
to identify the effectiveness of a written individualized action plan
(initiating early detection and prompt intervention) as an addition to usual
care.
Study objective
Primary Objective: To evaluate the effectiveness of an individualized AP
(initiating early detection of exacerbations and prompt intervention) on
recovery of symptom-based Quality of life in the event of an exacerbation.
Secondary Objective(s): To evaluate the effectiveness of an individualized AP
(initiating early detection of exacerbations and prompt intervention) on
recovery of symptoms and treatment delay (in the event of a symptom-based
exacerbation) healthcare utilisation, HRQoL, anxiety, depression, symptom
severity and self-efficacy.
Study design
A multicenter, single-blind, randomized controlled parallel study with a 6
months follow up period, comparing a written and individualized AP (as an
addition to care as usual) with care as usual.
Intervention
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 colour- coded overview of their stable
and deteriorated respiratory related symptoms/signs. In addition, the AP
provides individualized treatment prescriptions (both pharmaceutical and
non-pharmaceutical) related to the the colour coded symptom status. The AP is
made of double printed A3 size paper, which is folded as a brochure, but can
also be attached as a poster. The patient is instructed to bring the AP to
every visit to the GP, RP, RN, physiotherapist and dietician. In these visits,
the AP can be changed or made complete by one of these healthcare providers.
Study burden and risks
Burden and risks are minimal since care as usual is guaranteed which is checked
by patients* general practitioner or respiratory physician. The AP provides a
visual overview of treatment prescriptions and does not aim at changing but
underlines care as usual. Patients are asked to register variations from their
stable condition using symptom diary cards for the duration of 6 months. At
baseline and at 6 months follow-up patients are asked to fill in a
questionnaire. Every month (in total 6 times), healtcare utilization is
evaluated briefly by telephone.
Heidelberglaan 100
3584 CX Utrecht
Nederland
Heidelberglaan 100
3584 CX Utrecht
Nederland
Listed location countries
Age
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
- Primary diagnosis of asthma (onset < 35 years, >= 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
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 |
|---|---|
| CCMO | NL22904.041.08 |