Evaluation of a nursing intervention for smoking cessation in cardiac patients: a pilot randomised study

ISRCTN	ISRCTN26884027
DOI	https://doi.org/10.1186/ISRCTN26884027
Protocol serial number	GRIISIQ
Sponsor	Montreal Heart Institute (Institut de cardiologie de Montréal) (Canada)
Funder	Groupe de recherche interuniversitaire en interventions en sciences infirmières du Québec(GRIISIQ) (Canada)

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

R -1520, Montreal Heart Institute Research Center
5000 Belanger est
Montreal
H1T 1C8
Canada

Phone	+1 514 376 3330 ext 4012
Email	sylvie.cossette.inf@umontreal.ca

Study information

Primary study design	Interventional
Study design	Pilot randomised controlled trial, single centre
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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).
Key secondary outcome measure(s)	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?
Completion date	30/09/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

14/11/2022: Total final enrolment added.