Trial Outcomes & Findings for Evaluating a Telephone-Based Smoking Cessation Program Among People in the Military (The AFIII Study) (NCT NCT00632411)
NCT ID: NCT00632411
Last Updated: 2018-03-14
Results Overview
No cigarette smoking since two weeks after the target quit date.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1298 participants
Primary outcome timeframe
Measured at Year 1
Results posted on
2018-03-14
Participant Flow
Participant milestones
| Measure |
Proactive Group
Study staff will initiate contact to conduct 6 individual counseling sessions.
Participants will receive 8 weeks of Nicotine Replacement Therapy in the form of a patch.
|
Reactive Group
Participant will initiate contact with participant to conduct 6 individual counseling sessions.
Participants will receive 2 weeks of Nicotine Replacement Therapy in the form of a patch.
|
|---|---|---|
|
Overall Study
STARTED
|
649
|
649
|
|
Overall Study
COMPLETED
|
489
|
473
|
|
Overall Study
NOT COMPLETED
|
160
|
176
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating a Telephone-Based Smoking Cessation Program Among People in the Military (The AFIII Study)
Baseline characteristics by cohort
| Measure |
Proactive Group
n=649 Participants
Research study staff will contact participant to initiate sessions.
8 weeks of Nicotine Replacement Therapy in the form of patch will be distributed this group.
Six sessions will be proactively delivered to the participant.
Phone session 1 will focus on smoking reduction.
Phone session 2 will focus on preparing to quit and surviving the first days as a non-smoker. A quit date will be set in 7 to 10 days.
Phone session 3 will focus on the first days after the quit date.
Phone session 4 will focus on a review of progress and challenges of quitting. Plans to manage high-risk situations will be discussed.
Phone session 5 will focus on short-term relapse prevention.
Phone session 6 will focus on long-term relapse prevention.
|
Reactive Group
n=649 Participants
Participant will contact the research study staff to initiate sessions.
2 weeks of Nicotine Replacement Therapy in the form of patch will be distributed this group.
Six sessions will be delivered to the participant as long as the participant calls to initiate the sessions.
Phone session 1 will focus on smoking reduction.
Phone session 2 will focus on preparing to quit and surviving the first days as a non-smoker. A quit date will be set in 7 to 10 days.
Phone session 3 will focus on the first days after the quit date.
Phone session 4 will focus on a review of progress and challenges of quitting. Plans to manage high-risk situations will be discussed.
Phone session 5 will focus on short-term relapse prevention.
Phone session 6 will focus on long-term relapse prevention.
|
Total
n=1298 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
649 Participants
n=5 Participants
|
649 Participants
n=7 Participants
|
1298 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
39.59 years
STANDARD_DEVIATION 13.65 • n=5 Participants
|
39.42 years
STANDARD_DEVIATION 13.82 • n=7 Participants
|
39.50 years
STANDARD_DEVIATION 13.73 • n=5 Participants
|
|
Sex: Female, Male
Female
|
291 Participants
n=5 Participants
|
271 Participants
n=7 Participants
|
562 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
358 Participants
n=5 Participants
|
378 Participants
n=7 Participants
|
736 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
63 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
585 Participants
n=5 Participants
|
588 Participants
n=7 Participants
|
1173 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
13 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
85 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
493 Participants
n=5 Participants
|
509 Participants
n=7 Participants
|
1002 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
649 participants
n=5 Participants
|
649 participants
n=7 Participants
|
1298 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at Year 1Population: Participants
No cigarette smoking since two weeks after the target quit date.
Outcome measures
| Measure |
Proactive Group
n=521 Participants
Study staff will initiate contact to conduct 6 individual counseling sessions.
Participants will receive 8 weeks of Nicotine Replacement Therapy in the form of a patch.
|
Reactive Group
n=529 Participants
Participant will initiate contact with participant to conduct 6 individual counseling sessions.
Participants will receive 2 weeks of Nicotine Replacement Therapy in the form of a patch.
|
|---|---|---|
|
Continuous Abstinence
|
173 Participants
|
136 Participants
|
Adverse Events
Proactive Group
Serious events: 16 serious events
Other events: 307 other events
Deaths: 0 deaths
Reactive Group
Serious events: 6 serious events
Other events: 98 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Proactive Group
n=649 participants at risk
Study staff will initiate contact to conduct 6 individual counseling sessions.
Participants will receive 8 weeks of Nicotine Replacement Therapy in the form of a patch.
|
Reactive Group
n=649 participants at risk
Participant will initiate contact with participant to conduct 6 individual counseling sessions.
Participants will receive 2 weeks of Nicotine Replacement Therapy in the form of a patch.
|
|---|---|---|
|
Surgical and medical procedures
Hospitalization
|
2.5%
16/649 • Number of events 16 • 1 year
|
0.92%
6/649 • Number of events 6 • 1 year
|
Other adverse events
| Measure |
Proactive Group
n=649 participants at risk
Study staff will initiate contact to conduct 6 individual counseling sessions.
Participants will receive 8 weeks of Nicotine Replacement Therapy in the form of a patch.
|
Reactive Group
n=649 participants at risk
Participant will initiate contact with participant to conduct 6 individual counseling sessions.
Participants will receive 2 weeks of Nicotine Replacement Therapy in the form of a patch.
|
|---|---|---|
|
General disorders
Headache
|
2.2%
14/649 • Number of events 14 • 1 year
|
0.62%
4/649 • Number of events 4 • 1 year
|
|
Injury, poisoning and procedural complications
Skin Rash
|
13.6%
88/649 • Number of events 88 • 1 year
|
4.0%
26/649 • Number of events 26 • 1 year
|
|
Injury, poisoning and procedural complications
Sleep Disturbance
|
9.9%
64/649 • Number of events 64 • 1 year
|
2.9%
19/649 • Number of events 19 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory illness/ Sinus/ Sore throat/ Cold/Flu/Seasonal allergies
|
8.5%
55/649 • Number of events 55 • 1 year
|
2.0%
13/649 • Number of events 13 • 1 year
|
|
Injury, poisoning and procedural complications
Stomach illness/Nausea/Diarrhea
|
4.6%
30/649 • Number of events 30 • 1 year
|
2.2%
14/649 • Number of events 14 • 1 year
|
|
Injury, poisoning and procedural complications
Pain/Joint Pain/Muscle Aches/ Back Pain
|
3.5%
23/649 • Number of events 23 • 1 year
|
0.92%
6/649 • Number of events 6 • 1 year
|
|
Psychiatric disorders
Anxiety/Irritability
|
1.1%
7/649 • Number of events 7 • 1 year
|
0.31%
2/649 • Number of events 2 • 1 year
|
|
Metabolism and nutrition disorders
Fatigue/Lethargy
|
0.77%
5/649 • Number of events 5 • 1 year
|
0.77%
5/649 • Number of events 5 • 1 year
|
|
Cardiac disorders
Increased Heart Rate/Heart Palpitations
|
0.62%
4/649 • Number of events 4 • 1 year
|
0.31%
2/649 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Injury: knee/foot
|
0.62%
4/649 • Number of events 4 • 1 year
|
0.00%
0/649 • 1 year
|
|
Renal and urinary disorders
Hernia
|
0.62%
4/649 • Number of events 4 • 1 year
|
0.00%
0/649 • 1 year
|
|
Surgical and medical procedures
Gall bladder surgery
|
0.15%
1/649 • Number of events 1 • 1 year
|
0.31%
2/649 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
Urinary Tract Infection, Bladder problems
|
0.31%
2/649 • Number of events 2 • 1 year
|
0.15%
1/649 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Tooth extraction
|
0.15%
1/649 • Number of events 1 • 1 year
|
0.15%
1/649 • Number of events 1 • 1 year
|
|
Cardiac disorders
Elevated Blood Pressure
|
0.15%
1/649 • Number of events 1 • 1 year
|
0.15%
1/649 • Number of events 1 • 1 year
|
|
Ear and labyrinth disorders
Ringing in Ears
|
0.15%
1/649 • Number of events 1 • 1 year
|
0.15%
1/649 • Number of events 1 • 1 year
|
|
Infections and infestations
Ear Infection
|
0.15%
1/649 • Number of events 1 • 1 year
|
0.15%
1/649 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin biopsy
|
0.31%
2/649 • Number of events 2 • 1 year
|
0.00%
0/649 • 1 year
|
Additional Information
Dr. Robert Klesges
University of Tennessee Health Science Center
Phone: 901-448-3174
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place