Smoking Cessation, Hypertension
Conditions
Keywords
group education, smoking cessation, blood pressure
Brief summary
Smoking elderly males with stage 1 and 2 hypertension who currently smoked at least one cigarette per day and were willing to quit smoke will be invited to this cluster randomized, controlled, interventional, open clinical trial. The investigators will provide participants with group education of smoking cessation and their blood pressure measured at clinic at the sixth month is the primary endpoint. The investigators aim to explore how group education of smoking cessation effects smoking cessation, hypertension control and cardiovascular events.
Interventions
BEHAVIORALgroup education
Group education is one of strategies and behavioural interventions of smoking cessation. Lectures, group meeting for mutual support, discussion of coping skills and suggestions for prevention relapse can help smokers quit smoking by providing support and encouragement from people in same condition.
BEHAVIORALconventional smoking cessation management
Including regular follow-up of smoking status and giving advice of smoking cessation
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
65 Years to 84 Years
Healthy volunteers
Yes
Inclusion criteria
* signed the informed consent * aged 65 to 84 * new-onset hypertension or poorly controlled hypertension (140mmHg≤systolic blood pressure\<180mmHg and (or) 90mmHg≤ diastolic blood pressure\<110mmHg) * smoked last week and smoked more than 1 cigarette per day on average * be willing to quit smoking * can communicate normally and cooperate in blood pressure measurements, finishing questionnaires * complete interventions and follow-up consistently
Exclusion criteria
* home systolic blood pressure\<130mmHg and (or) home diastolic blood pressure\<80 mmHg * severe communication difficulties (aphasia, hearing impairment, etc.) * suffering from mental disorders such as anxiety and depression * cancer confirmed * with previous serious cardiovascular events such as acute coronary syndrome, acute left heart failure, stroke or with specific cardiovascular therapeutic device such as pacemakers * other serious physical illness or illness identified by investigators that unable to participant in study * using specific non-permitted medication currently
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change of clinic systolic blood pressure from baseline at the sixth month | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change of clinical blood pressure and home blood pressure from baseline | 1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years | — |
| Hypertension control rate | 1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years | — |
| Biochemical smoking cessation rate | 6 months | CO≤6 ppm |
| Self-reported 7-days smoking cessation rate | 1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years | — |
| Self-reported long-term smoking cessation rate | 1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years | Participants hadn't smoked for at least one month. |
| Self-reported average number of cigarettes smoked per day | 1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years | — |
| Relapse rate | 6 month | — |
| Cardiovascular events (cardiovascular death, stroke,myocardial infarction) | 6 months, 1 year, 2years, 3 years | — |
| FEV1-Pulmonary functions | 6 months | Forced expiratory volume in 1 second (FEV1) is the volume of air exhaled in the first second during forced exhalation after maximum inspiration. |
| PEF-Pulmonary functions | 6 months | Peak expiratory flow (PEF), the maximal flow that can be exhaled when blowing out at a steady rate. |
| FVC-Pulmonary functions | 6 months | Forced vital capacity (FVC), is the maximum amount of air that can be exhaled when blowing out as fast as possible. |
| Fagerstrom Test for Nicotine Dependence score | 6 months | The score of FTND ranges from 0 to 10. Participants with higher scores have higher degree of tobacco dependence and are less likely to maintain the status of smoking cessation. |
| Carbon monoxide concentration breathed | 6 months | — |
| Adverse events, including nicotine withdrawal symptoms and other adverse events. | 1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years | Nicotine withdrawal symptoms were quantified using the Minnesota Tobacco Withdrawal Scale (MNWS). |
| Mini-Mental State Examination score | 6 months | The cognitive function of participants will be assessed by MMSE. The score of MMSE ranges from 0 (worse) to 30 (better). |
Contacts
Primary ContactJiguang Wang, PhD
Outcome results
None listed