The purpose of this study is to explore and expand the understanding of the patient's experience of physical limitations in COPD from the perspective of the patient. The information will be used to support the development of a conceptual model…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The development of a conceptual model of physical activity and, subsequently,
the development of a Patient Reported Outcome (PRO) to assess physical acticity
in COPD patients.
Secondary outcome
not applicable
Background summary
In the next decade Chronic Obstructive Pulmonary Disease (COPD) will affect an
increasing number of European citizens. Physical inactivity and symptoms during
physical activity are a hallmark of COPD and inactivity itself contributes to
the diseaes progression. The inability to participate in daily activities is an
important consequence of COPD experiened by patients on a daily basis.
Improvement of the ability to participate in physicial activity with minimal
symptoms is an important patient centred target in the management of COPD.
Despite its importance, currently no Patient Reported Outcome (PRO) captures
physical activity in daily life in a way that is maximally reflects the
experience of COPD patients.
Study objective
The purpose of this study is to explore and expand the understanding of the
patient's experience of physical limitations in COPD from the perspective of
the patient. The information will be used to support the development of a
conceptual model of physical activity in people with COPD and develop a Patient
Reported Outcome to assess physical activity in patients with COPD.
Study design
The qualitative study consists of 3 steps:
1) In-depth interviews to explore and expand the understanding of the patient
experience of physical limitations as a results of having COPD.
2) Focus groups to derive items capturing relevant dimensions of physical
activity.
3) Cognitive debriefings to assess potential redundancy, patients'
understanding of the instructions and items, and potential relevance of the
identified items.
Study burden and risks
The results of this study might lead to optimise care for patients with COPD in
the future. The focus of this study is to develop a Patient Reported Outcome
(PRO) to assess physical activity in patients with COPD. The involvement of a
representative (i.e. heterogeneous) population of patients with COPD in this
study is crucial. Only based on the experiences of patients themselves the
final tool will be helpful for future purposes in research and daily clinical
practice. Participation in this study will only take some extra time for the
patients. Two visits to the hospital (one for interview or focus group meeting
and one for clinical testing) will be scheduled. Since there will be no
intervention, no direct benefits of participating in this study. Some patients,
however, may appreciate the extensive clinical testing. There are no
foreseeable risks in participating. No invasive clinical tests (apart from
routine tests) will be conducted.
Postbus 196
9700 AD Groningen
NL
Postbus 196
9700 AD Groningen
NL
Listed location countries
Age
Inclusion criteria
Patients (males and females) with physician diagnosed COPD (confirmed by pulmonary function testing), across the various GOLD stages from mild to very severe COPD.
- age > 40 years
- adequate oral fluency to enable participation in an interview
- willing and able to provide written informed consent
Exclusion criteria
- institutionalised patients (nursing home or psychiatric unit)
- patients with documented dementia or other mental impairment such that they are unable to provide informed consent or complete the required tasks
- patients in palliative care
- patients who don't speak and write the local or country language
- participants with major co-morbidities, which in the physician's opinion could have significant impact on physical activity. These include recent myocardial infarction, stroke, other cardiovascular conditions, rheumatologic disease (including arthritis and other musculoskeletal pain that affects their ability to exercise), neurological illness (including severe neuropathic pain that affects their ability to exercise), or traumatic injury, lung cancer, concurrent asthma, history of drug or alcohol abuse.
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 | NL31238.042.10 |