Smoking Clinical Trial
Official title:
Brief Intervention to Promote Smoking Cessation and Improve Glycemic Control in DM Smokers With Type 2 Diabetes: a Randomized Controlled Trial
The study is a randomized controlled trial (RCT) on a tailored smoking cessation
intervention targeted type 2 diabetic patients who smoke (DM intervention). The objectives
are:
1. to study the effectiveness of the DM intervention in achieving (a) smoking cessation,
(b) smoking reduction, and (c) progress to a higher stage of readiness to quit;
2. the changes in levels of HbA1c between (a) the intervention group and the controls, and
(b) quitters and continuing smokers;
3. the predictive factors for the success of the outcomes above.
Preventing multiple high-risk behaviors is an important focus in diabetes treatment. The
investigators found that cigarette smoking is a leading avoidable cause of death which kills
about 6,000 people annually, accounting for one of every five deaths in Hong Kong. The
smoking prevalence among males with diabetes (27.0%) is slightly higher than that of the
general male population (24.5%) in 2006. Smoking has long been known to worsen the prognosis
of diabetic patients in increasing the risks of macro- and micro-vascular complications and
there is also evidence that smoking increases insulin resistance, worsens diabetes control
[5] and may even induce the disease. Smoking cessation should be a natural choice for
smoking diabetic patients as it can reduce the risk of morbidity and mortality.
Smoking is an addictive behavior and quitting is very difficult with high chance of relapse.
Only a small percentage of smokers can quit without professional help. The stage-matched
smoking cessation intervention is a commonly used approach. Current diabetic treatments are
mostly focused on glucose-oriented care strategies, and specialized smoking cessation
counseling and support are rarely incorporated in routine practice of diabetes care. This
may be due to the already tight schedule of diabetic treatments and health care providers
often find it difficult to provide additional smoking cessation intervention to their
patients. Furthermore, smokers who have diabetes are more likely to be in the
pre-contemplation stage for quitting and they seem to have less interest in their health.
Many smokers who are not prepared to quit may reject smoking cessation intervention, hence
approaches that highlighting the relevance and salience of health information by making it
personally relevant (tailored) and addressing the specific characteristics of diabetic
patients (targeted) to promote cessation are needed. The investigators propose a
stage-matched smoking cessation intervention by increasing the relevance of health
information with respect to readiness to change of the individual and addressing the
relationship between smoking and diabetic complications and HbA1c level to increase the
relevance to all diabetic patients. It is hypothesized that diabetic patients would be more
likely to make change in smoking behavior, if health risks of diabetic complications and a
likelihood of an increase in HbA1c level were addressed simultaneously.
The study will consist of 2 phases, Phase I is a qualitative study with focus group
interviews and Phase II is a randomized controlled trial. In Phase I, current smoking and
ex-smoking patients with diabetes will be recruited in the DM clinics of nine hospitals by
purposive sampling for focus group interviews. Smoking diabetic patients will be recruited
for modifying and piloting of the survey instruments to be used in Phase II. In Phase II,
research assistants will determine the eligibility of patients in the clinics with the
following inclusion criteria: (1) smokes at least 2 cigarettes daily in the past 30 days,
(2) diagnosed with type 2 diabetes for at least 6 months such that their diabetic conditions
and treatments should be stable, (3) age 18 or above, and (4) can communicate in Cantonese;
and the exclusion criteria: (1) too sick to receive intervention, (2) poor cognitive state
(People with poor cognitive state refers to those with poor cognitive function and unable to
communicate logically), (3) mental illness, (4) is undergoing other smoking cessation
program, and (5) with unstable diabetic (i.e. those with poor diabetes condition that needed
hospitalization) or other medical conditions deemed to be not suitable by the doctor in
charge. After obtained written informed consent on-site, the subjects will be randomly
allocated either to the tailored and targeted smoking cessation intervention (DM) group, or
the control group.
Randomization will be done within each clinic. For each clinic, our trained counselors will
contact the consented subjects and administer the baseline questionnaire. The subject will
then be randomly allocated either into the intervention group or the control group. Based on
a block randomization design, the investigators shall generate a list of computer-based
random number using SAS® software for each hospital to allocate consented patients into
intervention or control group. Instead of distributing the random number list to the
counsellors directly, counsellors have to open a serially-numbered sealed-opaque envelop to
ensure allocation concealment. Counsellors will guide patients to complete the baseline
questionnaire before they open the sealed envelope and assign patients into the intervention
or control group. The envelope will contain an instruction sheet that specifies one of the
two groups. All the participants will complete the measurement of exhaled carbon monoxide
(CO) level at the site.
Analysis Data The qualitative data will be analyzed by using NVivo software for coding. The
quantitative data will be analyzed by using the Statistical Package for Social Science. The
baseline characteristics of the two groups will be compared by Chi-square test. The
effectiveness in helping smoking patients to quit of the DM intervention to the Control
group will be evaluated by comparing the percentages of participants with the outcomes in
each group using chi-square tests on an intention-to-treat analysis. Independent t-tests
will be used to compare the changes in HbA1c levels of the intervention group to the
control. Multiple regression and multiple logistic regressions will be used to calculate the
adjusted odds ratios for quitting: stage of readiness and reduction in cigarette
consumption; and change in other health-related lifestyle practices; between the
intervention and the control groups as well as between quitters and non-quitters. For
stopping rule, futility test will be performed. It indicates the cessation of the clinical
trial as soon as it becomes clear that a negative outcome (Control better than intervention)
or equivalence between treatments is very likely.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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