Contact information
Type
Scientific
Primary contact
Prof Sylvie Cossette
ORCID ID
Contact details
R -1520
Montreal Heart Institute Research Center
5000 Belanger est
Montreal
H1T 1C8
Canada
+1 514 376 3330 ext 4012
sylvie.cossette.inf@umontreal.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
GRIISIQ
Study information
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]
Acronym
SO LIVE-1
Study hypothesis
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
Institut de Cardiologie de Montréal Ethics Committee gave approval on the 7th September 2007 (ref: 08-1012)
Study design
Pilot randomised controlled trial, single centre
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
02/09/2008
Overall trial end date
30/09/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
Currently participating in another smoking cessation therapies program
Recruitment start date
02/09/2008
Recruitment end date
30/09/2009
Locations
Countries of recruitment
Canada
Trial participating centre
R -1520, Montreal Heart Institute Research Center
Montreal
H1T 1C8
Canada
Sponsor information
Organisation
Montreal Heart Institute (Institut de cardiologie de Montréal) (Canada)
Sponsor details
R -1520
Montreal Heart Institute Research Center
5000 Belanger est
Montreal
H1T 1C8
Canada
+1 514 376 3330
sylvie.cossette.inf@umontreal.ca
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Groupe de recherche interuniversitaire en interventions en sciences infirmières du Québec(GRIISIQ) (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2011 pilot study in www.ncbi.nlm.nih.gov/pubmed/21800642
Publication citations
-
Pilot study
Cossette S, Frasure-Smith N, Robert M, Chouinard MC, Juneau M, Guertin MC, Cournoyer A, Mailhot T, [A pre assessment for nursing intervention to support tobacco cessation in patients hospitalized for cardiac problems: a pilot study (So-Live)]., Rech Soins Infirm, 2011, 105, 60-75.