Group Education Helps Smoking Cessation and Hypertension Control

Not Applicable

Not yet recruiting

• Conditions: Smoking Cessation; Hypertension
• Interventions: Behavioral: conventional smoking cessation management; Behavioral: group education

• Registration Number: NCT05530083
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-24
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-06
• Study First Posted: 2022-09-07
• Last Update Submitted: 2022-09-29
• Last Update Posted: 2022-10-03
• Study Start: 2022-10-12
• Primary Completion: 2027-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 2000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional smoking cessation management	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.
group education	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.

Primary Outcome Measures

Name	Time	Method
change of clinic systolic blood pressure from baseline at the sixth month	6 months

Secondary Outcome Measures

Name	Time	Method
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	Participants hadn't smoked for at least one month.
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	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.
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.
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
Relapse rate	6 month
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).
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).