Back to resultsGroup Education Helps Smoking Cessation and Hypertension Control
Primary Purpose
Smoking Cessation, Hypertension
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
group education
conventional smoking cessation management
Sponsored by
About this trial
This is an interventional treatment trial for Smoking Cessation focused on measuring group education, smoking cessation, blood pressure
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
group education
conventional smoking cessation management
Arm Description
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.
The investigators will provide control groups with conventional smoking cessation management, including regular follow-up of smoking status and giving advice of smoking cessation.
Outcomes
Primary Outcome Measures
change of clinic systolic blood pressure from baseline at the sixth month
Secondary Outcome Measures
Cardiovascular events (cardiovascular death, stroke,myocardial infarction)
change of clinical blood pressure and home blood pressure from baseline
Hypertension control rate
Biochemical smoking cessation rate
CO≤6 ppm
Self-reported 7-days smoking cessation rate
Self-reported long-term smoking cessation rate
Participants hadn't smoked for at least one month.
Self-reported average number of cigarettes smoked per day
Relapse rate
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).
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.
PEF-Pulmonary functions
Peak expiratory flow (PEF), the maximal flow that can be exhaled when blowing out at a steady rate.
FVC-Pulmonary functions
Forced vital capacity (FVC), is the maximum amount of air that can be exhaled when blowing out as fast as possible.
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.
Carbon monoxide concentration breathed
Adverse events, including nicotine withdrawal symptoms and other adverse events.
Nicotine withdrawal symptoms were quantified using the Minnesota Tobacco Withdrawal Scale (MNWS).
Full Information
NCT ID
NCT05530083
First Posted
August 24, 2022
Last Updated
September 29, 2022
Sponsor
Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05530083
Brief Title
Group Education Helps Smoking Cessation and Hypertension Control
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 12, 2022 (Anticipated)
Primary Completion Date
January 1, 2027 (Anticipated)
Study Completion Date
January 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation, Hypertension
Keywords
group education, smoking cessation, blood pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group education
Arm Type
Experimental
Arm Description
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.
Arm Title
conventional smoking cessation management
Arm Type
Other
Arm Description
The investigators will provide control groups with conventional smoking cessation management, including regular follow-up of smoking status and giving advice of smoking cessation.
Intervention Type
Behavioral
Intervention Name(s)
group education
Intervention Description
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
Intervention Name(s)
conventional smoking cessation management
Intervention Description
Including regular follow-up of smoking status and giving advice of smoking cessation
Primary Outcome Measure Information:
Title
change of clinic systolic blood pressure from baseline at the sixth month
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Cardiovascular events (cardiovascular death, stroke,myocardial infarction)
Time Frame
6 months, 1 year, 2years, 3 years
Title
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
Title
Hypertension control rate
Time Frame
1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years
Title
Biochemical smoking cessation rate
Description
CO≤6 ppm
Time Frame
6 months
Title
Self-reported 7-days smoking cessation rate
Time Frame
1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years
Title
Self-reported long-term smoking cessation rate
Description
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
Title
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
Title
Relapse rate
Time Frame
6 month
Title
Mini-Mental State Examination score
Description
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
Title
FEV1-Pulmonary functions
Description
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
Title
PEF-Pulmonary functions
Description
Peak expiratory flow (PEF), the maximal flow that can be exhaled when blowing out at a steady rate.
Time Frame
6 months
Title
FVC-Pulmonary functions
Description
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
Title
Fagerstrom Test for Nicotine Dependence score
Description
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
Title
Carbon monoxide concentration breathed
Time Frame
6 months
Title
Adverse events, including nicotine withdrawal symptoms and other adverse events.
Description
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiguang Wang, PhD
Phone
+86-21-64370045
Ext
610911
Email
jiguangw@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Group Education Helps Smoking Cessation and Hypertension Control
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