Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04864327 |
| Other study ID # |
9538 |
| Secondary ID |
NMRR114779538 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 5, 2011 |
| Est. completion date |
December 1, 2012 |
Study information
| Verified date |
May 2021 |
| Source |
Ministry of Health, Malaysia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study determined the prevalence of tobacco smoking among patients with diabetes and
evaluated the impact of a diabetes-specific tobacco cessation intervention on tobacco
cessation outcomes and on the glycaemic control, blood pressure, lipid profile,
complications, comorbidities and number of cigarettes consumed per day among the patients.
Description:
The intervention protocol
Study Design and Study Population
This study is a randomized controlled trial involving diabetic patients who smoke tobacco,
attending the diabetes clinic at Penang General Hospital in Malaysia. The prevalence of
smoking among patients with diabetes will be measured by reviewing the patient who visit the
Endocrine department within three months. The minimum sample size needed for calculating the
prevalence estimated by using the equation below:
(Lwanga, S. K. and Lemeshow, S., 1991; Daniel, W. W., 1999; Cochran, W., 1977) n=(z^2 p
(1-p))/d^2
Where n = the sample size; Z = the statistic for the 95% level of confidence used in the
power analyses, which was 1.96; p = the expected prevalence or the proportion used, which was
0.5; and d = the precision used, which was 0.05. The estimated minimum sample size for the
prevalence is 348 patients. One thousand one hundred eighteen medical records reviewed to
find out the prevalence of smoking among the diabetic patients at the diabetes department in
Penang General Hospital. Among those 1118 diabetic patients there were 108 smoking diabetic
patients, depending on that; the prevalence of smoking among patients with diabetes will be
9.66%.
The study's participants will be randomly assigned into one of two groups: diabetes-specific
tobacco cessation counseling group (intervention group) and the usual physician counseling
group who will stay with the routine way in diabetes care counseling at Penang general
hospital (control group). Study participants in the two groups will fill-up a questionnaire
form to measure their knowledge, attitude, and practice of their physicians on smoking as a
part of diabetes care and as a risk factor for its deterioration and complications pre and
post the intervention.
Endocrinologists and physicians at the diabetic clinic will be asked to fill-up another
questionnaire form to evaluate their attitude and practice in smoking cessation counselling
among patients with diabetes and their willingness to apply the smoking cessation counselling
in their clinics. All participants will sign an informed consent form to approve their
agreement in their participation in the study.
Intervention Smoking Cessation Program among the Diabetic Patients The protocol of smoking
cessation consists of a routine assessment (asking) about cigarette use, advice on the
importance of quitting, an assessment of tobacco user's readiness to quit, assistance to set
a quit date, and arranging for follow-up visits (Fiore, M. C. et al., 2008). This protocol is
popularly known as the 5A's strategy. Tobacco users will be identified by staff nurses,
clinicians will provide a brief advice on quitting and the researcher will assess patient's
dependence and readiness to quit. Patients who are not ready to quit will be motivated to
consider doing so, whereas those who are ready to quit will be referred to practitioners who
can assist and follow them up in the smoking cessation clinic (American Diabetes Association,
2004).
All participants will be asked about their willingness to participate in the study, read the
patient information sheet, and sign the patient consent form to approve their agreement to
participate. Those who are willing to participate will be randomly assigned to either the
intervention group (put letter I sticker on their records) or control group (put letter C
sticker on their records). The assessment of readiness to quit smoking and nicotine
dependence at baseline and after 3 and 6 months from the baseline will be done by filling the
Fagerstrőm test questionnaire (FTQ) and Richmond test questionnaire. Patients will be
followed for 6 months which is the standard follow-up duration for reporting data from
clinical trials (Fiore, M. C. et al., 2008). Smoking abstinence or quitting will be confirmed
by measuring the CO level using breath CO analyser at baseline and at 3 and 6 months of the
intervention. Patients' glycaemic control, blood pressure, lipid profile, BMI, complication
and comorbidities; also any quitting attempt during the study period will be recorded at the
baseline and after 3 and 6 months as well from the patient's medical records and patients
themselves.
The study's intervention will be delivered by physicians (who provide diabetes care to the
participants), nurses and the smoking cessation clinic. The physicians will be trained on how
to advise the diabetic patients to stop smoking and supported by a booklet that can help them
for the wording in their counselling adapted from the guidelines. The smoking cessation
clinic will help patients who are ready to quit by setting a quitting date and arranging
follow-up visits for them. The intervention will be in compliance with the Malaysian
guideline for the treatment of tobacco use and dependence using the 5 A's protocol (Ask,
Advice, Assess, Assist, and Arrange for follow-up).
Randomization
In this study we use the Stat Trek's Random Number Generator to produce the random table to
randomise the study population into two groups (control and intervention). Assuming that
control group number 1 and intervention group is number 2 and we allow duplicate the values
in the table and by choosing the random starting point described previously in this section.
