To evaluate a result oriented smoking cessation program in which treatment goals are signed up in a doctor-patient contract.
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study endpoint: point prevalence after 24 months, measured by
self-reported smoking and biochemical verification (urinary cotinine
measurement).
Secondary outcome
Secondary study endpoint: abstinence after 12 en 24 months, functional status,
quality of life, attitude, social stimulation, self-efficacy, patiƫnt
perception, motivation, smoking habits and pulmonary function.
Background summary
Smoking cessation is the cornerstone the treatment of COPD since it reduces the
deterioration of pulmonary function. Apart from smoking cessation, physical
activity and proper use of medication lead to better quality of life and
functional status. However, these interventions are barely implemented in
everyday practice, most importantly due to lack of motivation of patients as
well as general practitioners. To obtain maximum profit out of COPD care,
motivated patients should be offered *result oriented* care instead of the
current *care oriented* care. Result oriented behavioural interventions with
treatment goals signed up in a doctor-patient contract are already applied
successfully in cardiac and lung rehabilitation programmes, treatment of
psychiatric diseases and in addiction care. With these interventions,
improvement of patients* adherence to treatment and self-management due to
shared decision making and patient empowerment is perceived. The use of a
doctor-patient contract targeting on smoking cessation and improvement of
quality of life and functional status of COPD patients has never been
investigated in primary care.
Study objective
To evaluate a result oriented smoking cessation program in which treatment
goals are signed up in a doctor-patient contract.
Study design
This is a two arm cluster randomised controlled trail, with general practice as
the unit of randomisation.
Intervention
All patients in the *result oriented* group will be asked, when motivated to
initiate a quit attempt, to compose treatment goals in a contract and attend an
intense smoking-cessation program.
After 6, 12 and 24 months the goals will be evaluated. Noncompliant patients
will again receive *care oriented care* for at least three months. During this
period they can again get motivated to participate once more in the
smoking-cessation program. When patients are not motivated to quit smoking they
will continuously receive *care oriented care* and are repeatedly point out the
advantages of *result oriented care*.
Study burden and risks
The burden and risks associated with participation: The participating patients
fill in questionnaires, undergo pulmonary function tests and 6 minutes walk
tests and their urinary cotinine level will be measured. The patients will
repeatedly consult the doctor (*care oriented care: 4 times in 2 year; *result
oriented* care(voluntarily):22 times in 2 year). All included patients will be
treated according to the Dutch College of General Practitioners guidelines
*COPD* and *smoking cessation*. There are no risks associated with
participation of this trial.
Postbus 85500
3508 GA Utrecht
NL
Postbus 85500
3508 GA Utrecht
NL
Listed location countries
Age
Inclusion criteria
COPD patients (FEV1/FVC < 70% predicted) Gold I - IV; age: 40-75 yrs; smokers.
Exclusion criteria
not familiar with the Dutch language
patients in the end stage of a disease
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 | NL15530.041.07 |