A comparison of Nicotine Replacement Therapy and Nicotine Replacement Therapy combined with the Minimal Intervention Strategy for smoking cessation in cardiovascular outpatients.
| ISRCTN | ISRCTN22579361 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22579361 |
| Secondary identifying numbers | NHF 2000/B216 |
- Submission date
- 29/08/2005
- Registration date
- 13/09/2005
- Last edited
- 08/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Dink A Legemate
Scientific
Scientific
PO Box 22700
Amsterdam
1100 DE
Netherlands
| Phone | +31(0)20-5667832 |
|---|---|
| d.a.legemate@amc.uva.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A comparison of Nicotine Replacement Therapy and Nicotine Replacement Therapy combined with the Minimal Intervention Strategy for smoking cessation in cardiovascular outpatients. |
| Study objectives | In the literature evidence exists that Nicotine Replacement Therapy (NRT) approximately doubles smoking cessation rates, regardless of the setting. The Minimal Intervention Strategy (MIS) is propagated by several health institutions, but its incremental effect to NRT in cardiovascular patients if performed by a nurse in an outpatient setting is not known. In this study it is hypothesised that the combination of C-MIS and NRT significantly decreases the number of smokers if compared with NRT alone. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular disease |
| Intervention | In the experimental arm: Nicotine Replacement Therapy (patches) and The Minimal Intervention Strategy (short behavioural counselling) In the control arm: only Nicotine Replacement Therapy (patches) |
| Intervention type | Mixed |
| Primary outcome measure | The primary endpoint of the study is smoking cessation at 12 months follow-up, as indicated by patient self-report and objectivated by urine cotinine levels. |
| Secondary outcome measures | Secondary endpoints are: 1. Changes in cognitions and smoking behaviour 2. Change in quality of life (generic and disease specific quality of life) 3. Adherence to NRT 4. Evaluation of the intervention |
| Overall study start date | 01/09/2001 |
| Completion date | 01/05/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 365 |
| Total final enrolment | 385 |
| Key inclusion criteria | Consecutive patients who attend the cardiological or vascular surgical outpatients clinic, have a diagnosis of atherosclerotic cardiac or arterial disease and who smoked until the cardiac event more than 5 cigarettes per day, will be included. |
| Key exclusion criteria | 1. Acute myocardial infarction in the month prior to randomisation 2. Unstable angina 3. Serious arrhythmia 4. Recent stroke 5. Skin allergy complicating the use of nicotine patches |
| Date of first enrolment | 01/09/2001 |
| Date of final enrolment | 01/05/2004 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
PO Box 22700
Amsterdam
1100 DE
Netherlands
1100 DE
Netherlands
Sponsor information
The Netherlands Heart Foundation (The Netherlands)
Charity
Charity
PO Box 300
Den Haag
2501 CH
Netherlands
| Phone | +31 (0)70-3155514 |
|---|---|
| research@hartstichting.nl | |
| Website | http://www.hartstichting.nl/research |
"ROR" |
https://ror.org/05nxhgm70 |
Funders
Funder type
Charity
The Netherlands Heart Foundation (The Netherlands) (ref: NHF2000/B216)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | Literature review | 01/11/2003 | Yes | No | |
| Other publications | Cognitive changes related to smoking behaviour | 01/06/2005 | Yes | No | |
| Other publications | Effect of patient preferences | 01/08/2005 | Yes | No | |
| Results article | 01/12/2006 | 08/11/2022 | Yes | No |
Editorial Notes
08/11/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
