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Effective Smoking Cessation Augmented PackagE (ESCAPE): evidence-based new service package vs. routine package to stop smoking

Evidence-based new service package vs. routine service package for smoking cessation to prevent high risk patients from cardiovascular diseases (CVD): a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN89315117
Enrollment
440
Registered
2013-07-09
Start date
2013-06-22
Completion date
Unknown
Last updated
2019-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking, Cardiovascular Disease (CVD) prevention Circulatory System

Interventions

Once the participants have agreed and consented to participate in the trial, he/she will be asked whether they are willing to attempt quitting smoking. If the participant agrees to quit smoking, he/sh

Sponsors

Ministry of Education, Culture, Sports, Science and Technology (Japan)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 21/08/2013: 1. Current smoker diabetes patient 2. Current smoker hypertensive patients 3. Current smoker with both diabetes and hypertension 4. Those who has never succeeded to stop smoking 5. Either sex 6. Age ranged from 35-80 years Previous inclusion criteria: 1. Current smoker diabetes patient 2. Current smoker hypertensive patients 3. Current smoker with both diabetes and hypertension 4. Those who has never succeeded to stop smoking 5. Either sex 6. Age ranged from 35-70 years

Exclusion criteria

Exclusion criteria: 1. Any female patients who are pregnant or planning to become pregnant 2. Patients aged younger than 35 years 3. Patients with documented type I diabetes 4. Patients with cancer 5. Patients with severe chronic pulmonary diseases using home oxygen therapy 6. Known diagnosis of previous cardiovascular disease (CVD) event

Design outcomes

Primary

MeasureTime frame
Smoking cessation rate at one-year follow-up proven by measurement of CO in parts per million (ppmCO). Smoking cessation is defined as continuous quitting smoking for at least six months, confirmed by smokerlyzer.

Secondary

MeasureTime frame
1. Smoking cessation rate at six months follow up proven by measurement of CO in parts per million (ppmCO) 2. CVD risk by Framingham general cardiovascular risk score at 12 months follow-up 3. Blood pressure and heart rate at six months and 12 months follow-up 4. CVD events and death at 12 months of follow-up 5. Cost-effectiveness of the health service packages at base line and twelve months of follow-up

Countries

Thailand

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 22, 2026