Group Education Helps Smoking Cessation and Hypertension Control

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05530083
• Other study ID #: GESHC
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 12, 2022
• Est. completion date: January 1, 2027

Study information

• Verified date: September 2022
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Jiguang Wang, PhD
• Phone: +86-21-64370045
• Email: jiguangw[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 65 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Smoking Cessation

Intervention

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.
• conventional smoking cessation management
Including regular follow-up of smoking status and giving advice of smoking cessation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of clinic systolic blood pressure from baseline at the sixth month		6 months
Secondary	Cardiovascular events (cardiovascular death, stroke,myocardial infarction)		6 months, 1 year, 2years, 3 years
Secondary	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
Secondary	Hypertension control rate		1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years
Secondary	Biochemical smoking cessation rate	CO=6 ppm	6 months
Secondary	Self-reported 7-days smoking cessation rate		1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years
Secondary	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
Secondary	Self-reported average number of cigarettes smoked per day		1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years
Secondary	Relapse rate		6 month
Secondary	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
Secondary	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
Secondary	PEF-Pulmonary functions	Peak expiratory flow (PEF), the maximal flow that can be exhaled when blowing out at a steady rate.	6 months
Secondary	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
Secondary	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
Secondary	Carbon monoxide concentration breathed		6 months
Secondary	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