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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 2,000
- Primary Endpoint
- change of clinic systolic blood pressure from baseline at the sixth month
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to 84 Years (Older Adult)
- Sex
- Male
- Accepts 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
Arms & Interventions
group education
The investigators will provide experimental groups with group education of smoking cessation, including lectures in groups of 50 to 100 people and panel discussion in groups of 5 to 10 people.
Intervention: group education (Behavioral)
conventional smoking cessation management
The investigators will provide control groups with conventional smoking cessation management, including regular follow-up of smoking status and giving advice of smoking cessation.
Intervention: conventional smoking cessation management (Behavioral)
Outcomes
Primary Outcomes
change of clinic systolic blood pressure from baseline at the sixth month
Time Frame: 6 months
Secondary Outcomes
- 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)
- Self-reported long-term smoking cessation rate(1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years)
- Carbon monoxide concentration breathed(6 months)
- Cardiovascular events (cardiovascular death, stroke,myocardial infarction)(6 months, 1 year, 2years, 3 years)
- Hypertension control rate(1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years)
- Self-reported average number of cigarettes smoked per day(1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years)
- PEF-Pulmonary functions(6 months)
- FVC-Pulmonary functions(6 months)
- Fagerstrom Test for Nicotine Dependence score(6 months)
- FEV1-Pulmonary functions(6 months)
- Biochemical smoking cessation rate(6 months)
- Self-reported 7-days smoking cessation rate(1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years)
- Relapse rate(6 month)
- Mini-Mental State Examination score(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)
Investigators
Ji-Guang Wang
Director of the Shanghai Institute of Hypertension and the Department of Hypertension
Shanghai Jiao Tong University School of Medicine