Ignite Creation Date:
2024-05-06 @ 9:11 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02922387
Status:
COMPLETED
Last Update Posted:
2016-10-04
First Post:
2016-09-27
Brief Title:
Smoking Cessation Intervention in Respiratory Inpatients
Sponsor:
General Hospital of Kavala
Organization:
General Hospital of Kavala
Study Overview
Official Title:
Varenicline and Advanced Behavioral Support on Smoking Cessation and Quality of Life in Inpatients With Acute Exacerbation of COPD Bronchial Asthma Attack or Community-acquired Pneumonia a Prospective Open-label 52-week Follow-up Trial
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Prospective open-label parallel-group 52-week trial comparing varenicline in combination with behavioral support with one session of behavioral support alone
Eligible patients were smokers hospitalized due to a acute exacerbation of chronic obstructive pulmonary disease COPD or b bronchial asthma attack or c community-acquired pneumonia CAP
The primary outcome was the success rate at week 52 Secondary outcomes were quality of life QoL alterations on the domains of the 36-Item Short Form Health Survey SF36 and investigation of possible predictors for smoking abstinence
Eligible patients were smokers hospitalized due to a acute exacerbation of chronic obstructive pulmonary disease COPD or b bronchial asthma attack or c community-acquired pneumonia CAP
The primary outcome was the success rate at week 52 Secondary outcomes were quality of life QoL alterations on the domains of the 36-Item Short Form Health Survey SF36 and investigation of possible predictors for smoking abstinence
Detailed Description:
Patients screened for eligibility were all the smokers who were hospitalized in the First Pulmonology Clinic of Kavala General Hospital from May 2012 to May 2014
Patients had an initial private consultation session and motivational interview while still in the hospital Following this interview patients chose the smoking cessation intervention they preferred either the standard regimen for varenicline and behavioral support or behavioral support without pharmacotherapy
All patients quit smoking while still hospitalizedFollow-up phone calls with a minimum duration of 10 minutes were scheduled in weeks 1 2 4 and months 36 and 9 following smoking cessation
Patients in both groups were asked to return to hospital in month 12 week 52 for a final assessment At this last visit the SF36 was again completed and exhaled CO was re measured
Patients had an initial private consultation session and motivational interview while still in the hospital Following this interview patients chose the smoking cessation intervention they preferred either the standard regimen for varenicline and behavioral support or behavioral support without pharmacotherapy
All patients quit smoking while still hospitalizedFollow-up phone calls with a minimum duration of 10 minutes were scheduled in weeks 1 2 4 and months 36 and 9 following smoking cessation
Patients in both groups were asked to return to hospital in month 12 week 52 for a final assessment At this last visit the SF36 was again completed and exhaled CO was re measured
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None