Evaluation of a nursing intervention for smoking cessation in cardiac patients: a pilot randomised study
| ISRCTN | ISRCTN26884027 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26884027 |
| Secondary identifying numbers | GRIISIQ |
- Submission date
- 01/10/2008
- Registration date
- 09/10/2008
- Last edited
- 14/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Sylvie Cossette
Scientific
Scientific
R -1520, Montreal Heart Institute Research Center
5000 Belanger est
Montreal
H1T 1C8
Canada
| Phone | +1 514 376 3330 ext 4012 |
|---|---|
| sylvie.cossette.inf@umontreal.ca |
Study information
| Study design | Pilot randomised controlled trial, single centre |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Preliminary evaluation of a nursing intervention to support smoking cessation in patients hospitalised for a cardiac problem: a pilot study [Évaluation préliminaire dune intervention infirmière de soutien à la cessation tabagique chez des patients hospitalisés pour un problème cardiaque: une étude pilote] |
| Study acronym | SO LIVE-1 |
| Study objectives | It is hypothesised that patients in the intervention group will present a lower rate of smoking than the control group at six months post-randomisation. It is also hypothesised that patients in the intervention group will have a more important progression in the stages of change regarding their intention to quit smoking than the control group at six months post-randomisation. |
| Ethics approval(s) | Institut de Cardiologie de Montréal Ethics Committee gave approval on the 7th September 2007 (ref: 08-1012) |
| Health condition(s) or problem(s) studied | Smoking cessation |
| Intervention | Eligible patients will be met by the research nurse during the hospitalisation and the research will be presented to them. Usual care will be provided to all patients during the hospitalisation based on stages of changes and the motivational interview. The two groups will answer a questionnaire about the secondary outcomes and the baseline characteristics will be recorded. After being discharged from the hospital, the participants will be randomly assigned to the intervention or control group. Intervention group: After randomisation, the nurse will contact the patient by phone six times: one call per week for the first month (T2a, T2b, T2c, T2d), one call at the end of the second month (T2e) and the third month (T2f). During each of these contacts, the nurse will evaluate the stage of readiness to stop smoking and the conviction and confidence to stop smoking. Following the assessment, the nurse will intervene following a list of interventions specific to the stage where the patient belongs and depending on his conviction and confidence levels. The patient will be able to contact the nurse by phone from the third month until the sixth month after randomisation. Finally, motivational letters will be sent to the patient until six months post-randomisation to encourage and support the efforts of the patient. Control group: Usual care following discharge involved referring the control group patients as usual to external smoking cessation services. These services include follow up phone calls and interventions of social support, advices and pharmacological support. Patients are contacted by phone at different times after their discharge if they did refuse that service or if they were not referred at the time of discharge. |
| Intervention type | Other |
| Primary outcome measure | Smoking status (yes/no) at six months post-randomisation. This information will be provided by the patient himself. To validate this information the patient will be invited to have a nicotine detection test (saliva or urine). |
| Secondary outcome measures | Measured at baseline and six months following randomisation by phone and are as follows: 1. Progression in the stages of change. The stage of readiness to change will be evaluated by the nurse during the six contacts and at six months post-randomisation by the research assistant. 2. Patient's perception of control over the disease and of its consequences using three subscales of the Illness Perception Questionnaire - Revised (IPQ-R): 2.1. Consequences (6 items) 2.2. Personal control (6 items) 2.3. Treatment control (5 items) 3. Patient's perception regarding the support received by a relative to increase perception of control to stop smoking using the Family Care Climate Questionnaire - Patient Version (FCCQ-P) 4. Cardiovascular risks factors used as a secondary outcomes are diet and physical exercise. To measure these two dimensions we will use two scales: 4.1. Do you have a healthy heart? 4.2. Are you eating healthily? |
| Overall study start date | 02/09/2008 |
| Completion date | 30/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Total final enrolment | 40 |
| Key inclusion criteria | 1. Male and female, aged greater than 18 years old or more 2. Daily smokers 3. Having the physical and cognitive capacities to fill out questionnaires and to communicate by telephone 4. Being able to communicate in French or in English |
| Key exclusion criteria | Currently participating in another smoking cessation therapies program |
| Date of first enrolment | 02/09/2008 |
| Date of final enrolment | 30/09/2009 |
Locations
Countries of recruitment
- Canada
Study participating centre
R -1520, Montreal Heart Institute Research Center
Montreal
H1T 1C8
Canada
H1T 1C8
Canada
Sponsor information
Montreal Heart Institute (Institut de cardiologie de Montréal) (Canada)
Research organisation
Research organisation
R -1520, Montreal Heart Institute Research Center
5000 Belanger est
Montreal
H1T 1C8
Canada
| Phone | +1 514 376 3330 |
|---|---|
| sylvie.cossette.inf@umontreal.ca | |
| Website | http://www.umontreal.ca/ |
"ROR" |
https://ror.org/03vs03g62 |
Funders
Funder type
Research organisation
Groupe de recherche interuniversitaire en interventions en sciences infirmières du Québec(GRIISIQ) (Canada)
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? |
|---|---|---|---|---|---|
| Results article | pilot study | 01/06/2011 | Yes | No |
Editorial Notes
14/11/2022: Total final enrolment added.
