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Not yet recruiting NCT05530083

Group Education Helps Smoking Cessation and Hypertension Control

No phase Interventional Smoking Cessation Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: group education, conventional smoking cessation management.
Who it may be relevant to
Registry conditions: Smoking Cessation, Hypertension. Basic parameters: 65 years — 84 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

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

Primary outcome measures

  • change of clinic systolic blood pressure from baseline at the sixth month [Time frame: 6 months]
Secondary outcome measures (12)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05530083 · GESHC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗