Group Education Helps Smoking Cessation and Hypertension Control

N/ANot Yet RecruitingNCT05530083

Shanghai Jiao Tong University School of Medicine2,000 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

2,000

Conditions

Smoking Cessation Hypertension

Interventions

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.

Eligibility

Sex: MALEMin age: 65 YearsMax age: 84 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

change of clinic systolic blood pressure from baseline at the sixth month

Time frame: 6 months

Secondary Outcomes

Cardiovascular events (cardiovascular death, stroke,myocardial infarction)

Time frame: 6 months, 1 year, 2years, 3 years

change of clinical blood pressure and home blood pressure from baseline

Time frame: 1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years

Hypertension control rate

Time frame: 1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years

Biochemical smoking cessation rate

CO≤6 ppm

Time frame: 6 months

Self-reported 7-days smoking cessation rate

Time frame: 1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years

Self-reported long-term smoking cessation rate

Participants hadn't smoked for at least one month.

Time frame: 1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years

Self-reported average number of cigarettes smoked per day

Time frame: 1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years

Relapse rate

Time frame: 6 month

Mini-Mental State Examination score

The cognitive function of participants will be assessed by MMSE. The score of MMSE ranges from 0 (worse) to 30 (better).

Time frame: 6 months

FEV1-Pulmonary functions

Forced expiratory volume in 1 second (FEV1) is the volume of air exhaled in the first second during forced exhalation after maximum inspiration.

Time frame: 6 months

PEF-Pulmonary functions

Peak expiratory flow (PEF), the maximal flow that can be exhaled when blowing out at a steady rate.

Time frame: 6 months

FVC-Pulmonary functions

Forced vital capacity (FVC), is the maximum amount of air that can be exhaled when blowing out as fast as possible.

Time frame: 6 months

Fagerstrom Test for Nicotine Dependence score

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.

Time frame: 6 months

Carbon monoxide concentration breathed

Time frame: 6 months

Adverse events, including nicotine withdrawal symptoms and other adverse events.

Nicotine withdrawal symptoms were quantified using the Minnesota Tobacco Withdrawal Scale (MNWS).

Time frame: 1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years

Group Education Helps Smoking Cessation and Hypertension Control

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts