No registrations found.
ID
Source
Brief title
Health condition
COPD
motivation
smoking cessation
contract
Sponsors and support
Intervention
Outcome measures
Primary outcome
Point prevalence after 24 months, measured by self-reported smoking and urinary cotinine measurement
Secondary outcome
Smoking abstinence, functional status, motivation for smoking cessation, illness perception, quality of life, social stimulation, self-efficacy, smoking habits and pulmonary function
Background summary
Rationale:
Smoking cessation is the cornerstone of COPD treatment since it reduces the decline in pulmonary function. However, this intervention is barely implemented in everyday practice. To obtain maximum profit of COPD care, motivated patients should be offered ‘result-focused’ care, in which treatment goals are signed up in a doctor-patient contract, instead of the current ‘effort-focused’ care. ‘Result-focused’ behavioural interventions are already applied successfully in rehabilitation programs, psychiatric treatments and addiction care.
Objective:
To evaluate a ‘result-focused’ smoking-cessation-program (‘Golden care’) in which treatment goals are signed up in a doctor-patient contract.
Study design:
A two-arm, cluster randomised controlled trial, with general practice as unit of randomization.
Study population:
720 smoking COPD patients
Intervention:
All patients of the intervention group receive ‘Silver care’. When
motivated to initiate a quit attempt, treatment goals are composed in a doctor-patient contract and the patient attends an intense smoking-cessation-program (‘Golden care’). After 6, 12 and 24 months goals will be evaluated. Noncompliant patients will again receive ‘Silver care’ for at least three months to get motivated for smoking cessation once more. Patients unmotivated to quit smoking will continuously receive ‘Silver care’.
Main endpoints:
Primary endpoint: point prevalence after 24 months, measured by self-reported smoking and urinary cotinine measurement.
Secondary endpoint: smoking abstinence, functional status, motivation for smoking cessation, illness perception, quality of life, social stimulation, self-efficacy, smoking habits and pulmonary function.
Statistical analysis:
Intention-to-treat analysis. Primary outcome is measured by logistic regression analysis. Differences in secondary outcome measures are measured by co-variation analysis.
Study objective
The objective of this study is to evaluate a ‘result oriented’ smoking cessation program (‘Silver or Gold’) for COPD patients in which treatment goals are signed up in a doctor-patient contract.
Study design
Baseline, 1 year, 2 years
Intervention
Intervention group:
All patients of the intervention group receive ‘Silver care’. When
motivated to initiate a quit attempt, treatment goals are composed in a doctor-patient contract and the patient attends an intense smoking-cessation-program (‘Golden care’). After 6, 12 and 24 months goals will be evaluated. Noncompliant patients will again receive ‘Silver care’ for at least three months to get motivated for smoking cessation once more. Patients unmotivated to quit smoking will continuously receive ‘Silver care’.
Control group:
Patients in the control group receive care as usual
P.O. 85500
M.J. Warnier
Huispost STR. 6.131 (kamer 4.143)
Utrecht 3508 GA
The Netherlands
+31 (0)88 7555102
M.J.Warnier@umcutrecht.nl
P.O. 85500
M.J. Warnier
Huispost STR. 6.131 (kamer 4.143)
Utrecht 3508 GA
The Netherlands
+31 (0)88 7555102
M.J.Warnier@umcutrecht.nl
Inclusion criteria
1. COPD patient
2. Age 40 – 75 year
3. Smoker. A smoker is someone who says to smoke daily or incidentally.
Exclusion criteria
1. Terminally stage of a (chronic) disease
2. Not speaking Dutch
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 |
---|---|
NTR-new | NL1259 |
NTR-old | NTR1305 |
Other | : ABR 15530 |
ISRCTN | ISRCTN wordt niet meer aangevraagd |