Smoking CessationNCT05530083
Group Education Helps Smoking Cessation and Hypertension Control
A study testing group education and conventional smoking cessation management in people with Smoking Cessation and Hypertension, run by Shanghai Jiao Tong University School of Medicine.
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. Read more about this study
- Who is it for?
- Ages 65 to 84 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Hypertension
- What is being tested?
- group education and conventional smoking cessation management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 12 Oct 2022to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 84 years
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Being tested
- group education, conventional smoking cessation management
- Keywords
- group education, smoking cessation, blood pressure
- Medical subject headings
- Smoking Cessation, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group educationBehavioural
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 managementBehavioural
Including regular follow-up of smoking status and giving advice of smoking cessation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: conventional smoking cessation management |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of clinic systolic blood pressure from baseline at the sixth month
Measured: 6 months
Secondary outcomes (15)
Cardiovascular events (cardiovascular death, stroke,myocardial infarction)
Measured: 6 months, 1 year, 2years, 3 years
change of clinical blood pressure and home blood pressure from baseline
Measured: 1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years
Hypertension control rate
Measured: 1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years
Biochemical smoking cessation rate
CO≤6 ppm
Measured: 6 months
Self-reported 7-days smoking cessation rate
Measured: 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.
Measured: 1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years
Self-reported average number of cigarettes smoked per day
Measured: 1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years
Relapse rate
Measured: 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).
Measured: 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.
Measured: 6 months
PEF-Pulmonary functions
Peak expiratory flow (PEF), the maximal flow that can be exhaled when blowing out at a steady rate.
Measured: 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.
Measured: 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.
Measured: 6 months
Carbon monoxide concentration breathed
Measured: 6 months
Adverse events, including nicotine withdrawal symptoms and other adverse events.
Nicotine withdrawal symptoms were quantified using the Minnesota Tobacco Withdrawal Scale (MNWS).
Measured: 1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start12 Oct 2022 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji-Guang Wang, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530083
- Sponsor's protocol ID
- GESHC
- Status last verified
- Sep 2022
- First submitted
- 24 Aug 2022
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05530083
- Acronym / sponsor ID
- GESHC
- Conditions
- Smoking Cessation, Hypertension
- Keywords
- group education, smoking cessation, blood pressure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 12 Oct 2022 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 7 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group education | Experimental | Behavioral: group educationThe 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. |
| conventional smoking cessation management | Other | Behavioral: conventional smoking cessation managementThe investigators will provide control groups with conventional smoking cessation management, including regular follow-up of smoking status and giving advice of smoking cessation. |
Who may qualify
- Ages
- 65 to 84 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| group educationGroup 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. | Behavioural | group education |
| conventional smoking cessation managementIncluding regular follow-up of smoking status and giving advice of smoking cessation | Behavioural | conventional smoking cessation management |
Primary outcome
change of clinic systolic blood pressure from baseline at the sixth month
Time frame: 6 months
15 secondary outcomes
Cardiovascular events (cardiovascular death, stroke,myocardial infarction)
Time frame: 6 months, 1 year, 2years, 3 years
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
Hypertension control rate
Time frame: 1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years
Biochemical smoking cessation rate
Time frame: 6 months
Self-reported 7-days smoking cessation rate
Time frame: 1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years
Self-reported long-term smoking cessation rate
Time frame: 1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years
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
Relapse rate
Time frame: 6 month
Mini-Mental State Examination score
Time frame: 6 months
FEV1-Pulmonary functions
Time frame: 6 months
PEF-Pulmonary functions
Time frame: 6 months
FVC-Pulmonary functions
Time frame: 6 months
Fagerstrom Test for Nicotine Dependence score
Time frame: 6 months
Carbon monoxide concentration breathed
Time frame: 6 months
Adverse events, including nicotine withdrawal symptoms and other adverse events.
Time frame: 1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing group education and conventional smoking cessation management in people with Smoking Cessation and Hypertension, run by Shanghai Jiao Tong University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiguang Wang, PhD (+86-21-64370045 ext. 610911, jiguangw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of clinic systolic blood pressure from baseline at the sixth month (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2022.