Clinical trial NCT05530083: Group Education Helps Smoking Cessation and Hypertension Control
Official title: A Cluster Randomized Trial to Evaluate the Effect of Group Education on Smoking Cessation and Blood Pressure in Smoking Elderly Males With Stage 1 and 2 Hypertension
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Smoking Cessation
Hypertension
Keywords: group education
smoking cessation
blood pressure
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 2000
Sex: MALE
Minimum age (years): 65
Maximum age (years): 84
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: change of clinic systolic blood pressure from baseline at the sixth month
timeFrame: 6 months
Secondary outcomes:
measure: Cardiovascular events (cardiovascular death, stroke,myocardial infarction)
timeFrame: 6 months, 1 year, 2years, 3 years
measure: change of clinical blood pressure and home blood pressure from baseline
timeFrame: 1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years
measure: Hypertension control rate
timeFrame: 1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years
measure: Biochemical smoking cessation rate
timeFrame: 6 months
measure: Self-reported 7-days smoking cessation rate
timeFrame: 1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years
measure: Self-reported long-term smoking cessation rate
timeFrame: 1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years
measure: Self-reported average number of cigarettes smoked per day
timeFrame: 1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years
measure: Relapse rate
timeFrame: 6 month
measure: Mini-Mental State Examination score
timeFrame: 6 months
measure: FEV1-Pulmonary functions
timeFrame: 6 months
measure: PEF-Pulmonary functions
timeFrame: 6 months
measure: FVC-Pulmonary functions
timeFrame: 6 months
measure: Fagerstrom Test for Nicotine Dependence score
timeFrame: 6 months
measure: Carbon monoxide concentration breathed
timeFrame: 6 months
measure: Adverse events, including nicotine withdrawal symptoms and other adverse events.
timeFrame: 1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years
Other outcomes:
Locations:
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