Group Education Helps Smoking Cessation and Hypertension Control

NCT05530083 | Not Yet Recruiting DMC

• 1 other identifier: GESHC
• Study Type: interventional
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

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

Keywords

group education; smoking cessation; blood pressure

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (15)

• Cardiovascular events (cardiovascular death, stroke,myocardial infarction)

  6 months, 1 year, 2years, 3 years

• 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

• Hypertension control rate

  1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years

• 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

Study Arms (2)

group education

EXPERIMENTAL

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.

Behavioral: group education

conventional smoking cessation management

OTHER

The investigators will provide control groups with conventional smoking cessation management, including regular follow-up of smoking status and giving advice of smoking cessation.

Behavioral: conventional smoking cessation management

Interventions

group education 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.

group education

conventional smoking cessation management BEHAVIORAL

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

conventional smoking cessation management

Eligibility Criteria

• Age: 65 Years - 84 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

MeSH Terms

Conditions

Smoking Cessation; Hypertension

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Jiguang Wang, PhD

CONTACT

+86-21-64370045; jiguangw@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Shanghai Institute of Hypertension and the Department of Hypertension

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: September 7, 2022
• Study Start: October 12, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 3, 2022

Record last verified: 2022-09