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NCT Number: NCT05530083

Group Education Helps Smoking Cessation and Hypertension Control

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.

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Key information

Conditions

Smoking Cessation Behavior Cardiovascular Diseases Health Behavior Hypertension Vascular Diseases

Age range

65 year–84 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

conventional smoking cessation management

Behavioral

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

Primary outcomes

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

    Time frame: 6 months

Secondary outcomes

  1. Cardiovascular events (cardiovascular death, stroke,myocardial infarction)

    Time frame: 6 months, 1 year, 2years, 3 years

  2. 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

  3. Hypertension control rate

    Time frame: 1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years

  4. Biochemical smoking cessation rate

    Time frame: 6 months

    CO≤6 ppm

  5. Self-reported 7-days smoking cessation rate

    Time frame: 1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years

  6. Self-reported long-term smoking cessation rate

    Time frame: 1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years

    Participants hadn't smoked for at least one month.

  7. 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

  8. Relapse rate

    Time frame: 6 month

  9. Mini-Mental State Examination score

    Time frame: 6 months

    The cognitive function of participants will be assessed by MMSE. The score of MMSE ranges from 0 (worse) to 30 (better).

  10. FEV1-Pulmonary functions

    Time frame: 6 months

    Forced expiratory volume in 1 second (FEV1) is the volume of air exhaled in the first second during forced exhalation after maximum inspiration.

  11. PEF-Pulmonary functions

    Time frame: 6 months

    Peak expiratory flow (PEF), the maximal flow that can be exhaled when blowing out at a steady rate.

  12. FVC-Pulmonary functions

    Time frame: 6 months

    Forced vital capacity (FVC), is the maximum amount of air that can be exhaled when blowing out as fast as possible.

  13. Fagerstrom Test for Nicotine Dependence score

    Time frame: 6 months

    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.

  14. Carbon monoxide concentration breathed

    Time frame: 6 months

  15. 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

    Nicotine withdrawal symptoms were quantified using the Minnesota Tobacco Withdrawal Scale (MNWS).

Study contacts

Contact information is provided by the study sponsor or research team.

Jiguang Wang, PhD

CONTACT

[email protected]

+86-21-64370045 ext. 610911

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Sep 7, 2022
Registry last updated
Oct 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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