Background
Methods
Study design
Study setting
Study population
Participant selection and illegibility
Sample size calculation
Randomization
Interventions
Initiation visit protocol
Pharmaceutical treatment
Rotation procedures
Statistical analyses
Results
Baseline characteristics and between-arms comparison
Sociodemographic characteristics
Variable | Total | Control group | Intervention group | p-value |
---|---|---|---|---|
Age: mean ± SD | 43.65 ± 14.04 | 43.16 ± 15.29 | 44.19 ± 12.14 | 0.415 |
Sex ratio | 18.08 | 20.36 | 0.836 | |
Male: n (%) | 459 (95) | 235 (94.8) | 224 (95.3) | |
Female: n (%) | 24 (5) | 13 (05.2) | 11 (04.7) | |
Distance to clinic: n (%) | ||||
In 20 km radios | 422 (91.1) | 206 (88.8) | 216 (93.5) | 0.101 |
Out 20 km radios | 41 (8.9) | 26 (11.2) | 15 (06.5) | |
Schooling level: n (%) | 0.291 | |||
Unschooled | 6 (1.3) | 1 (0.4) | 5 (02.2) | |
Primary school | 114 (25.1) | 61 (26.4) | 53 (23.8) | |
Secondary school | 147 (32.4) | 90 (39.0) | 57 (25.6) | |
High school | 57 (12.6) | 17 (07.4) | 40 (17.9) | |
Two years of higher education | 47 (10.4) | 17 (07.4) | 30 (13.5) | |
Higher | 83 (18.3) | 45 (19.5) | 38 (17.0) | |
Profession: n (%) | ||||
Active | 312 (67.8) | 147 (62.6) | 165 (73.3) | 0.136 |
Unemployed | 39 (8.5) | 27 (11.5) | 12 (05.3) | |
Student | 39 (8.5) | 26 (11.1) | 13 (05.8) | |
Retired | 67 (14.6) | 32 (13.6) | 35 (15.6) | |
With physical disability | 3 (0.7) | 3 (01.3) | 0 (0.0) | |
Familial issues: n (%) | ||||
Yes | 126 (27.8) | 70 (30.0) | 56 (25.5) | 0.295 |
No | 327 (72.2) | 163 (70.0) | 164 (74.5) | |
Professional issues: n (%) | ||||
Yes | 120 (28) | 63 (28.1) | 57 (25.9) | 0.669 |
No | 324 (72) | 161 (71.9) | 163 (74.1) |
Smoking profile
Characteristics | Total | Control group | Spirometry Group | p-value |
---|---|---|---|---|
First cigarette age: mean ± SD | 17.33 ± 4.71 | 17.11 ± 4.76 | 17.57 ± 4.66 | 0.438 |
Regular smoking age: mean ± SD | 20.16 ± 4.97 | 19.74 ± 5.13 | 20.59 ± 4.92 | 0.463 |
Cigarette/day: mean ± SD | 31.23 ± 15.88 | 32.13 ± 16.51 | 30.27 ± 15.14 | 0.203 |
Light smoker: n (%) | 26 (05) | 14 (05.6) | 12 (05.1) | |
Moderate smoker: n (%) | 27 (05) | 14 (05.6) | 13 (05.5) | |
Heavy smoker: n (%) | 257 (53) | 123 (49.6) | 134 (57.0) | 0.321 |
Super heavy smoker: n(%) | 162 (33) | 93 (37.5) | 69 (29.4) | |
Pack-Year: mean ± SD | 37.07 ± 29.45 | 35.51 ± 31.46 | 38.70 ± 26.19 | 0.258 |
Budget for smoking: (Tunisian Dinars/week) mean ± SD | 36.2 ± 14.4 | 37.7 ± 23.7 | 35.5 ± 28.2 | 0.378 |
Fagerstrom score: mean ± SD | 6.46 ± 2.27 | 6.46 ± 2.28 | 6.46 ± 2.26 | 0.974 |
HAD score: mean ± SD | 13.56 ± 6.71 | 13.82 ± 7.03 | 13.26 ± 6.35 | 0.568 |
Anxiety Score | 8.31 ± 4.21 | 8.44 ± 4.28 | 8.17 ± 4.13 | 0.498 |
Depression Score | 5.27 ± 3.59 | 5.42 ± 3.81 | 5.12 ± 3.33 | 0.372 |
Characteristics | Total | Control group | Spirometry Group | p-value |
---|---|---|---|---|
Other smokers at home: yes n (%) | 135 (28.97) | 76 (31.1) | 59 (26.3) | 0.251 |
Use of other forms of tobacco: yes n (%) | 55 (13.78) | 30 (12.3) | 25 (16.2) | 0.096 |
Coffee drink per day: mean | 2.86 | 2.88 | 2.84 | 0.824 |
Meal per day: mean | 2.73 | 2.8 | 2.66 | 0.063 |
Alcohol consumption: yes n (%) | 137 (29.0) | 77 (31.6) | 60 (26.2) | 0.199 |
Physical activity (hour/week): mean | 1.01 | 1.09 | 0.91 | 0.106 |
Clinical features
Variables | Total | Control group | Spirometry group | p-value |
---|---|---|---|---|
Anamneses | ||||
History of cardiovascular disease: n (%) | 83 (17.4) | 44 (18.0) | 39 (16.7) | 0.725 |
History of pulmonary disease: n (%) | 39 (08.1) | 27 (11.0) | 17 (07.3) | 0.163 |
History of psychiatric disease: n (%) | 13 (02.7) | 8 (03.3) | 5 (02.1) | 0.452 |
History of diabetes: n (%) | 88 (18.2) | 48 (19.6) | 42 (18.0) | 0.662 |
Number of comorbidities: n (%) | ||||
0 | 298 (62.3) | 129 (52,7) | 169 (72.5) | 0.093 |
1 | 140 (29.3) | 86 (35.1) | 54 (23.2) | |
2 | 38 (07.9) | 29 (11.8) | 9 (3.9) | |
3 | 02 (0.4) | 1 (0.4) | 1 (0.4) | |
Symptom, dyspnea: n (%) | 295 (65.7) | 152 (67.9) | 143 (63.6) | 0.337 |
Symptom, couth: n (%) | 276 (61.6) | 150 (61.7) | 135 (57.4) | 0.340 |
Symptom, chest pain: n (%) | 197 (44.1) | 107 (48.2) | 90 (40.0) | 0.081 |
Symptom, epigastralgia: n (%) | 182 (40.6) | 95 (42.6) | 87 (38.7) | 0.397 |
Symptom, dental damage: n (%) | 332 (67.3) | 173 (70.6) | 159 (67.7) | 0.484 |
Other symptoms: n (%) | 29 (06.5) | 12 (05.4) | 17 (07.6) | 0.356 |
Clinical examination | ||||
Weight: mean ± SD | 77.56 ± 17.08 | 76.22 ± 15.91 | 78,84 ± 18.08 | 0.126 |
Height: mean ± SD | 174.52 ± 8.87 | 174.01 ± 07.87 | 174,99 ± 9.68 | 0.269 |
BMI: mean ± SD | 25.54 ± 4.79 | 25.26 ± 04.70 | 25,79 ± 4.86 | 0.291 |
Systolic Blood Pressure (SBP): mean ± SD | 124.81 ± 18.14 | 121.81 ± 19.52 | 121,72 ± 16.69 | 0.957 |
Diastolic Blood Pressure (DBP): mean ± SD | 75.14 ± 13.27 | 75.50 ± 10.16 | 76,97 ± 10.41 | 0.198 |
Capillary glycemia (Dextro): mean ± SD | 1.16 ± 0.45 | 1.21 ± 0.52 | 1,13 ± 0.39 | 0.137 |
CO-Oxymetry: mean ± SD | 11.07 ± 6.750 | 10.63 ± 6.53 | 11,57 ± 6.98 | 0.159 |
Quitting motivation
Characteristics | Control group | Spirometry Group | p-value |
---|---|---|---|
Importance of quitting (score/10): mean ± SD | 9.14 ± 1.89 | 9.37 ± 1.34 | 0.161 |
Quitting confidence (score/10): mean ± SD) | 7.14 ± 2.88 | 7.38 ± 2.65 | 0.269 |
Longest previous cessation period: n (%) | |||
None | 35 (16.1) | 29 (14.8) | 0.350 |
Less than 6 months | 149 (68.7) | 125 (63.8) | |
Between 6 and 12 months | 9 (04.1) | 15 (07.7) | |
More than 12 months | 24 (11.1) | 27 (13.8) | |
Delay to the last cessation attempt: n (%) | |||
None | 35 (16.3) | 28 (14.4) | 0.069 |
Less than 6 months | 21 (09.8) | 46 (23.7) | |
Between 6 and 12 months | 30 (14.0) | 24 (12.4) | |
More than 12 months | 129 (60.0) | 96 (49.5 | |
Main quitting argument: n (%) | |||
Health | 207 (93.7) | 207 (91.6) | 0.781 |
Family | 2 (0.9) | 4 (1.8) | |
Money | 4 (1.8) | 4 (1.8) | |
Others | 8 (3.6) | 11 (4.9) | |
Main quitting concerns: n (%) | |||
None | 97 (43.7) | 75 (36.4) | 0.530 |
Stress | 91 (41.0) | 74 (35.9) | |
Obesity | 6 (2.7) | 7 (3.4) | |
Onset of a disease | 20 (9.0) | 33 (16.0) | |
Other | 8 (3.6) | 16 (7.8) | |
Prochaska: n (%) | |||
Contemplation | 64 (29.1) | 61 (29.2) | 0.878 |
Preparation | 45 (20.5) | 49 (23.4) | |
Action | 101 (45.9) | 85 (40.7) | |
Maintenance | 1 (0.5) | 0 (0.0) | |
Relapse | 9 (4.1) | 14 (06.7) |
Follow-up and outcome
Outcome variable | Control group | Spirometry group | p-value |
---|---|---|---|
Treatment availability: n (%) | 70.3% | 71.9% | 0.757 |
Number of visits: n (%) | 3.01 | 5,74 | 0.000 |
Six months—cessation rate n (%: IC95%) | 78 (33.1:27.1–39.1) | 106 (48.0: 41.4–54.6) | 0.002 |
One year—cessation rate n (%: IC95%) | 39 (16.5: 11.7–21.2) | 56 (25.5: 19.7–31.3) | 0.019 |
Smoking reduction (cigarettes / day) mean | 10.05 | 12.22 | 0.349 |