Group Education Helps Smoking Cessation and Hypertension Control

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

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 Overview

• Status: Not yet recruiting
• Conditions: Smoking Cessation; Hypertension
• Intervention / Treatment: Behavioral: group education; Behavioral: conventional smoking cessation management

• Study Type: Interventional
• Enrollment (Anticipated): 2000
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 84 years (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Behavioral: 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.
OTHER: 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.	Behavioral: conventional smoking cessation management; Including regular follow-up of smoking status and giving advice of smoking cessation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change of clinic systolic blood pressure from baseline at the sixth month	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	CO≤6 ppm	6 months
Self-reported 7-days smoking cessation rate		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.	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
Relapse rate		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).	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.	6 months
PEF-Pulmonary functions	Peak expiratory flow (PEF), the maximal flow that can be exhaled when blowing out at a steady rate.	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.	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.	6 months
Carbon monoxide concentration breathed		6 months
Adverse events, including nicotine withdrawal symptoms and other adverse events.	Nicotine withdrawal symptoms were quantified using the Minnesota Tobacco Withdrawal Scale (MNWS).	1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 12, 2022
• Primary Completion (ANTICIPATED): January 1, 2027
• Study Completion (ANTICIPATED): January 1, 2027

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (ACTUAL): September 7, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 29, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: blood pressure; smoking cessation; group education
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: GESHC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No