Group Education Helps Smoking Cessation and Hypertension Control

NCT ID: NCT05530083

Last Updated: 2022-10-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-12
• Study Completion Date: 2027-01-01

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.

Conditions

Smoking Cessation; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

group education

Intervention Type: BEHAVIORAL

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.

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 Type: OTHER

conventional smoking cessation management

Intervention Type: BEHAVIORAL

Including regular follow-up of smoking status and giving advice of smoking cessation

Interventions

group 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.

Intervention Type: BEHAVIORAL

conventional smoking cessation management

Including regular follow-up of smoking status and giving advice of smoking cessation

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Ji-Guang Wang

Director of the Shanghai Institute of Hypertension and the Department of Hypertension

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Jiguang Wang, PhD

Role: CONTACT

jiguangw@163.com

+86-21-64370045 ext. 610911

Other Identifiers

GESHC

Identifier Type: -

Identifier Source: org_study_id