Canga 2000.
Study characteristics | ||
Methods | Design: Randomized controlled trial Setting: 15 primary care centres, 2 hospitals, Spain Recruitment: Identified through practice records |
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Participants | 280 people who smoked with diabetes (incl 16 recent quitters) aged 17 ‐ 84 (133 control, 147 intervention), average age 40.7, 19 cpd, 15% female, did not need to be motivated to quit | |
Interventions | Intervention: participants received a 40‐minute, face‐to‐face interview on smoking cessation with a nurse and set a quit date. Participants also received self‐help materials. All of those who smoked heavily received nicotine patches unless contraindicated. In addition, participants were provided with a follow‐up program consisting of 5 contacts: a telephone call the day before the quit date, a follow‐up visit 2 weeks after the quit date, a letter 3 weeks after the quit day, a second follow‐up visit 2 months after the quit date, and a final evaluation after 6 months. Control: participants received usual care, established in the Navarre diabetes care program, including advice to quit smoking. No further details reported |
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Outcomes | > 5m sustained abstinence at 6m Quit attempts Validation: Urine cotinine < 20 ng/ml |
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Funding Source | Not reported | |
Author's declarations of interest | Not reported | |
Notes | Strategy: Adjunctive counseling Level: Patient Comparison type: Single component vs. standard care It is not possible to separate the primary care settings' data from the secondary care settings' data, and so this study is not included in any meta‐analyses |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Sequence Generation | Low risk | Computer‐generated allocation method |
Allocation concealment | Low risk | Sealed envelopes |
Blinding of outcome assessors All outcomes | Low risk | Smoking status was validated by urinary cotinine |
Incomplete outcome data All outcomes | Low risk | Overall, 0.7% of participants were lost to follow‐up |