Cost Free Pharmacotherapy for Smoking Cessation in Stroke Patients
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Purpose
This pilot study examined the effect of providing a 4 weeks of cost free quit smoking medications to smokers identified in a stroke prevention clinic who were interested in quitting smoking compared to providing a prescription for the medication only.
| Condition | Intervention |
|---|---|
|
Stroke |
Other: cost free pharmacotherapy Other: usual care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | A Randomized Controlled Pilot Study of Standardized Counselling and Cost-free Pharmacotherapy for Smoking Cessation Among Stroke and TIA Patients |
- smoking abstinence [ Time Frame: 6-months ] [ Designated as safety issue: No ]The dependent variables of primary interest were measured at 26 weeks and included: (1) bio-chemically confirmed 7-day point prevalence abstinence; and (2) continuous abstinence since TQD. Participants who were not available for follow-up were considered smokers. At the 26 week follow-up, all patients who reported being abstinent from smoking had their smoking status confirmed by measurement of a CO sample. If any CO was >10 ppm, the subject was considered a smoker.
- quit attempts [ Time Frame: 6-months ] [ Designated as safety issue: No ]At the 26 week follow-up assessments patient quit attempts in the previous six months of 24 hours or longer were documented.
- adherence with intervention [ Time Frame: 6-months ] [ Designated as safety issue: No ]During the 26-week telephone follow-up assessment patient adherence with pharmacotherapy was assessed by evaluating the number of doses of pharmacotherapy consumed within the prescribed study interval. The telephone counsellor recorded the completion of all seven counselling sessions in order to assess patient adherence.
| Enrollment: | 28 |
| Study Start Date: | August 2008 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cost Free Pharmacotherapy
Participants assigned to the CF group received a starter kit (4-week supply) of cost-free quit smoking medication (nicotine replacement therapy, bupropion, or varenicline) and a pre-printed prescription to be filled by the patient at the end of the 4-weeks.
|
Other: cost free pharmacotherapy
Participants assigned to the CF group received a starter kit (4-week supply) of cost-free quit smoking medication (nicotine replacement therapy, bupropion, or varenicline) and a pre-printed prescription to be filled by the patient at the end of the 4-weeks.
|
|
Active Comparator: Usual Care Group
Participants assigned to the prescription only usual care group received a prescription for smoking cessation pharmacotherapy to be filled at their own cost at their local community pharmacy.
|
Other: usual care
Participants assigned to the prescription only usual care group received a prescription for smoking cessation pharmacotherapy to be filled at their own cost at their local community pharmacy.
|
Detailed Description:
DESIGN: Randomized controlled trial. METHODS: All patients seen at the Ottawa Hospital Stroke Prevention Clinic were screened for smoking status, advised to quit smoking and treated using a standardized protocol including counselling and pharmacotherapy. Eligible smokers were randomly assigned to either a prescription only usual care group, or, the experimental group who received a 4-week supply of cost-free quit smoking medications and prescription for medication renewal. All patients received follow-up counselling 7-days prior to and 5, 14, 30, 60, 90, 180 days following their quit attempt. Levels of eligibility, consent, adherence and retention were used as indicators of study feasibility. The primary outcome was bio-chemically validated quit rates at 26-weeks.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients were eligible to participate in the study if they reported smoking an average of 5 or more cigarettes per day in past 3 months; were 18 years of age or older; were willing to set a quit date in the next 30 days; and were willing to use a quit smoking medication.
Exclusion Criteria:
- Patients who were unable to read and understand English or French or who had contraindications to all approved smoking cessation medications (nicotine replacement therapy, bupropion, and varenicline) were excluded from the study.
Contacts and Locations| Canada, Ontario | |
| University of Ottawa Heart Institute | |
| Ottawa, Ontario, Canada, K1Y4W7 | |
| Principal Investigator: | Robert Reid, Ph.D. | Associate Director and Professor |
More Information
No publications provided
| Responsible Party: | Robert Reid, University of Ottawa Heart Institute |
| ClinicalTrials.gov Identifier: | NCT01404546 History of Changes |
| Other Study ID Numbers: | UOHI2010-1 |
| Study First Received: | July 26, 2011 |
| Last Updated: | July 26, 2011 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by University of Ottawa Heart Institute:
|
stroke smoking cessation cost-free pharmacotherapy |
Additional relevant MeSH terms:
|
Smoking Stroke Cerebral Infarction Habits Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on June 18, 2013