Trial Outcomes & Findings for Integrating Financial Management Counseling and Smoking Cessation Counseling to Reduce Health and Economic Disparities in Low-Income Immigrants (NCT NCT03187730)
NCT ID: NCT03187730
Last Updated: 2021-06-18
Results Overview
Participants answered "In the past 7 days, have you smoked a cigarette? (yes/no)"; % of "yes" is reported per arm
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
410 participants
Primary outcome timeframe
6 Months
Results posted on
2021-06-18
Participant Flow
Participant milestones
| Measure |
Intervention Arm
Integrated Smoking Cessation and Financial Counseling: Participants in the intervention group will receive up to nine counseling sessions that integrate two evidence-based counseling approaches: financial management counseling and smoking cessation counseling. Participants will also be eligible to receive a free four-week supply of NRT. Participants will be surveyed at baseline, 2- months, 6-months and 12-months to assess outcomes and treatment satisfaction.
Nicotine Replacement Therapy (NRT): Participants in both arms will be eligible to receive a free four-week supply of NRT.
|
Waitlist Control
Waitlist Integrated Smoking Cessation and Financial Counseling: Control participants in the waitlist control group will receive usual care for the first 6 months of the study, while the Intervention Arm receives integrated counseling. The waitlist control group will receive the same counseling program as the Intervention group 6 months after enrollment (up to nine counseling sessions and four weeks of NRT). Participants will be surveyed at baseline, 2-months, 6-months and 12-months to assess outcomes and treatment satisfaction.
Nicotine Replacement Therapy (NRT): Participants in both arms will be eligible to receive a free four-week supply of NRT.
|
|---|---|---|
|
Overall Study
STARTED
|
208
|
202
|
|
Overall Study
COMPLETED
|
129
|
154
|
|
Overall Study
NOT COMPLETED
|
79
|
48
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Integrating Financial Management Counseling and Smoking Cessation Counseling to Reduce Health and Economic Disparities in Low-Income Immigrants
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=208 Participants
Integrated Smoking Cessation and Financial Counseling: Participants in the intervention group will receive up to nine counseling sessions that integrate two evidence-based counseling approaches: financial management counseling and smoking cessation counseling. Participants will also be eligible to receive a free four-week supply of NRT. Participants will be surveyed at baseline, 2- months, 6-months and 12-months to assess outcomes and treatment satisfaction.
Nicotine Replacement Therapy (NRT): Participants in both arms will be eligible to receive a free four-week supply of NRT.
|
Waitlist Control
n=202 Participants
Waitlist Integrated Smoking Cessation and Financial Counseling: Control participants in the waitlist control group will receive usual care for the first 6 months of the study, while the Intervention Arm receives integrated counseling. The waitlist control group will receive the same counseling program as the Intervention group 6 months after enrollment (up to nine counseling sessions and four weeks of NRT). Participants will be surveyed at baseline, 2-months, 6-months and 12-months to assess outcomes and treatment satisfaction.
Nicotine Replacement Therapy (NRT): Participants in both arms will be eligible to receive a free four-week supply of NRT.
|
Total
n=410 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.2 years
n=5 Participants
|
52.5 years
n=7 Participants
|
52.85 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
139 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
264 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
105 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
222 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
103 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
98 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
190 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
51 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
208 participants
n=5 Participants
|
202 participants
n=7 Participants
|
410 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 MonthsParticipants answered "In the past 7 days, have you smoked a cigarette? (yes/no)"; % of "yes" is reported per arm
Outcome measures
| Measure |
Intervention Arm
n=128 Participants
Integrated Smoking Cessation and Financial Counseling: Participants in the intervention group will receive up to nine counseling sessions that integrate two evidence-based counseling approaches: financial management counseling and smoking cessation counseling. Participants will also be eligible to receive a free four-week supply of NRT. Participants will be surveyed at baseline, 2- months, 6-months and 12-months to assess outcomes and treatment satisfaction.
Nicotine Replacement Therapy (NRT): Participants in both arms will be eligible to receive a free four-week supply of NRT.
|
Waitlist Control
n=155 Participants
Waitlist Integrated Smoking Cessation and Financial Counseling: Control participants in the waitlist control group will receive usual care for the first 6 months of the study, while the Intervention Arm receives integrated counseling. The waitlist control group will receive the same counseling program as the Intervention group 6 months after enrollment (up to nine counseling sessions and four weeks of NRT). Participants will be surveyed at baseline, 2-months, 6-months and 12-months to assess outcomes and treatment satisfaction.
Nicotine Replacement Therapy (NRT): Participants in both arms will be eligible to receive a free four-week supply of NRT.
|
|---|---|---|
|
% of Participants Who Had Smoked Cigarette(s) in the Past 7 Days (at 6 Months From Baseline)
|
27 % of participants
|
13 % of participants
|
Adverse Events
Intervention Arm
Serious events: 11 serious events
Other events: 0 other events
Deaths: 3 deaths
Waitlist Control
Serious events: 5 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Intervention Arm
n=208 participants at risk
Integrated Smoking Cessation and Financial Counseling: Participants in the intervention group will receive up to nine counseling sessions that integrate two evidence-based counseling approaches: financial management counseling and smoking cessation counseling. Participants will also be eligible to receive a free four-week supply of NRT. Participants will be surveyed at baseline, 2- months, 6-months and 12-months to assess outcomes and treatment satisfaction.
Nicotine Replacement Therapy (NRT): Participants in both arms will be eligible to receive a free four-week supply of NRT.
|
Waitlist Control
n=202 participants at risk
Waitlist Integrated Smoking Cessation and Financial Counseling: Control participants in the waitlist control group will receive usual care for the first 6 months of the study, while the Intervention Arm receives integrated counseling. The waitlist control group will receive the same counseling program as the Intervention group 6 months after enrollment (up to nine counseling sessions and four weeks of NRT). Participants will be surveyed at baseline, 2-months, 6-months and 12-months to assess outcomes and treatment satisfaction.
Nicotine Replacement Therapy (NRT): Participants in both arms will be eligible to receive a free four-week supply of NRT.
|
|---|---|---|
|
General disorders
Hospitaliztion
|
5.3%
11/208 • Number of events 11 • 6 months
|
2.5%
5/202 • Number of events 5 • 6 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place