search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Optimizing COPD care in primary care: 'going for Silver or for Gold'


- candidate number3264
- NTR NumberNTR1305
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-mei-2008
- Secondary IDsABR 15530 
- Public TitleOptimizing COPD care in primary care: 'going for Silver or for Gold'
- Scientific TitleOptimizing COPD care in primary care: 'going for Silver or for Gold'
- ACRONYMSilver or Gold
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedSmoking, COPD, Motivation, Contract
- Inclusion criteria1. COPD patient
2. Age 40 – 75 year
3. Smoker. A smoker is someone who says to smoke daily or incidentally.
- Exclusion criteria1. Terminally stage of a (chronic) disease
2. Not speaking Dutch
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2008
- planned closingdate1-sep-2010
- Target number of participants720
- InterventionsIntervention 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
- Primary outcomePoint prevalence after 24 months, measured by self-reported smoking and urinary cotinine measurement
- Secondary outcomeSmoking abstinence, functional status, motivation for smoking cessation, illness perception, quality of life, social stimulation, self-efficacy, smoking habits and pulmonary function
- TimepointsBaseline, 1 year, 2 years
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. M.J. Warnier
- CONTACT for SCIENTIFIC QUERIESDrs. M.J. Warnier
- Sponsor/Initiator Julius Center for Health Sciences and Primary Care
- Funding
(Source(s) of Monetary or Material Support)
PICASSO
- PublicationsN/A
- Brief summaryRationale:
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.

- Main changes (audit trail)
- RECORD5-mei-2008 - 5-mei-2008


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl