Condition category
Mental and Behavioural Disorders
Date applied
01/10/2008
Date assigned
09/10/2008
Last edited
21/03/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 d’une 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

http://www.umontreal.ca/

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

  1. 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.

Additional files

Editorial Notes