|- candidate number||6814|
|- NTR Number||NTR2144|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||15-dec-2009|
|- Secondary IDs||120620021 / 09215 ZonMw / METCnr. VUMC Amsterdam |
|- Public Title||Smoking Cessation among Patients with Coronary Heart disease. |
|- Scientific Title||Effectiveness of two intensive counselling methods for smoking cessation and relapse prevention in persons with coronary heart disease. |
|- hypothesis||Smoking cessation after development of coronary heart disease improves prognosis
more than any other treatment and prevents future cardiovascular diseases. This study aims to provide hospitalized coronary heart disease patients who smoke with proven (cost)effective smoking cessation interventions. Point prevalence abstinence is estimated in the experimental groups at 60% at 6 months, against 43% in the control group. After 12 months, 55% abstinence in experimental groups and 35% in the control group are estimated. |
|- Healt Condition(s) or Problem(s) studied||Smoking cessation, Coronary artery disease|
|- Inclusion criteria||Patients who are admitted with coronary heart disease at cardiac wards and smoked at least five cigarettes a week prior to hospital admission will be recruted. Inclusion criteria are: |
1. Stable cardiac situation;
2. One of the following diagnoses: angina pectoris, myocardial infarction, post-PCI, post-CABG or a combination;
3. 18 years or older;
4. Sufficiently fluent in Dutch and able to read Dutch.
|- Exclusion criteria||Exlusion criteria are:|
1. Unstable cardiac situation;
2. Terminal stage of the disease;
3. Smoking less than 5 cigarettes per week;
4. Smoking cessation more than one month prior to hospital admission;
5. Insufficiently fluent in Dutch.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||15-okt-2009|
|- planned closingdate||1-nov-2011|
|- Target number of participants||894|
|- Interventions||The interventions consist of intensive counselling by smoking cessation professionals, either by telephone in one intervention and by face-to-face counselling in the other. These comparable interventions differ in delivery mode and
duration. In both interventions, ward nurses start assessing patientsí smoking behaviour followed by providing stop-smoking advice and referral to smoking cessation counselling. In one intervention, we deliver counselling by telephone (TC), in the other face-to-face (FC). During the TC, the patient is called seven times x fifteen minutes. During the FC, the patient has six consultations x 45 minutes with the personal coach and a telephone follow-up call five weeks after the last consultation (fifteen minutes). Both interventions include nicotine replacement therapy and will be compared to the usual care cardiac wards deliver to support cardiac patients to quit smoking. |
|- Primary outcome||Primary outcome will be point prevalence abstinence from smoking (PPA) after 6 and 12 months. PPA is considered to be the most sensitive and valid measure of smoking cessation. |
|- Secondary outcome||Secondary outcomes will be continued abstinence, quit attempts, lapses and relapse into smoking. Health outcomes that will be measured are new coronary events, hospital readmissions for coronary events, TC/HDL cholesterol ratio, blood pressure, prescribed medication, number of visits to the cardiologist since discharge.|
In telephone interview after 6 and 12 months will assess: visits to general practitioner in past months, cardiology outpatient visits in past months, hospitalisations in past months and death related to cardiovascular disease, contacts with caregivers, absence from work due to illness, and resource use specifically for the interventions. Patients who die during the study will directly be excluded from the study to avoid any further contact with family.
The baseline measurement (questionnaire) and the 6 and 12 months post-test (telephone interview) will also include factors that are related to smoking cessation and/ or relapse among this patient population. These include:
2. Smoking related factors (smoking history, addiction);
3. Disease related factors (severity of disease, diagnosis);
5. Psychological state (depression, anxiety, type D behaviour);
6. Smoking cessation related cognitions (for example attitude, selfefficacy, smoking behaviour of important others) only measured baseline.
|- Timepoints||1. Baseline measurement while patients are hospitalized at cardiac wards;|
2. Follow-up measurements 6 months and 12 months after the baseline measurement.
Total inclusion period is 9 months for every participating hospital.
|- Trial web site||Website CCMO.|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||drs. Nadine Berndt|
|- CONTACT for SCIENTIFIC QUERIES||dr. Catherine Bolman|
|- Sponsor/Initiator ||Open University the Netherlands, University Maastricht (UM), STIVORO|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Publications||Berndt, N.C., Bolman, C., Lechner, L., Mudde, A., de Vries, H. (2012). Effectiveness of two intensive treatment methods for smoking cessation and relapse prevention in patients with coronary heart disease: study protocol and baseline description. BMC Cardiovascular Disorders, 12 (1), 33.
|- Brief summary||Cardiovascular disease is one of the leading causes of death in the Netherlands, and coronary heart diseases have an important share in this. Smoking cessation after development of coronary heart disease improves prognosis more than any other treatment and prevents future cardiovascular diseases. Smoking cessation reduces the risk of reoccurrence of coronary events after one year by 50%. However, 57% of those who smoked prior to a cardiac event persist in smoking or relapse. The study which is running at present has been implemented as there is need for improved intensive and feasible smoking cessation interventions for Dutch cardiac inpatients. After its completion, this study aims to provide hospitalized coronary heart disease patients who smoke with effective smoking cessation interventions. This study is a collaboration with cardiac wards of eight hospitals throughout the Netherlands. By means of an experimental study design with one baseline measurement and two follow-up measurements (after 6 and 12 months), two intensive counselling interventions (personal coaching and telephone coaching, both including nicotine replacement therapy) will be compared to the usual care to explore their (cost-) effectiveness. The feasibility of the interventions (in case of proved effectiveness) in practice will also be studied to detect relevant conditions for large-scale dissemination to the general hospital public. |
|- Main changes (audit trail)|
|- RECORD||15-dec-2009 - 16-dec-2012|