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.
ID
Bron
Verkorte titel
Aandoening
COPD
motivation
smoking cessation
contract
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Point prevalence after 24 months, measured by self-reported smoking and urinary cotinine measurement
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
Baseline, 1 year, 2 years
Onderzoeksproduct en/of interventie
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
Algemeen / deelnemers
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
Wetenschappers
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. COPD patient
2. Age 40 – 75 year
3. Smoker. A smoker is someone who says to smoke daily or incidentally.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Terminally stage of a (chronic) disease
2. Not speaking Dutch
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL1259 |
NTR-old | NTR1305 |
Ander register | : ABR 15530 |
ISRCTN | ISRCTN wordt niet meer aangevraagd |