{"doc_desc":{"title":"Assessing the efficacy and impact of a personalised smoking cessation intervention among type 2 diabetic smokers: an open label randomised controlled trial","producers":[{"name":"Center for Primary Care and Public Health (Unisant\u00e9), University of Lausanne, Switzerland","abbreviation":"Unisant\u00e9","affiliation":"","role":""}],"version_statement":{"version":"Version 1.0 (02.2022)"}},"study_desc":{"title_statement":{"idno":"10.16909-dataset-34","title":"Assessing the efficacy and impact of a personalised smoking cessation intervention among type 2 diabetic smokers: an open label randomised controlled trial","sub_title":"DISCGo-RCT"},"authoring_entity":[{"name":"CLAIR, Carole","affiliation":"Center for Primary Care and Public Health (Unisant\u00e9), Department of ambulatory care (DDP)"}],"production_statement":{"producers":[{"name":"LOCATELLI, Isabella","affiliation":"Center for Primary Care and Public Health (Unisant\u00e9), Department of epidemiology and health systems (DESS)","role":"Statistician"},{"name":"JACOT-SADOWSKI, Isabelle","affiliation":"Center for Primary Care and Public Health (Unisant\u00e9), Department of Prevention and Health Promotion (DPSP)","role":"Collaborator"},{"name":"BERLIN, Ivan","affiliation":"Center for Primary Care and Public Health (Unisant\u00e9), Department of Prevention and Health Promotion (DPSP)","role":"Collaborator"},{"name":"ZANCHI, Ane","affiliation":"Service of Endocrinology, Diabetes and Metabolism, Centre Hospitalier Universitaire Vaudois (CHUV)","role":"Collaborator"},{"name":"PUDER, Jardena","affiliation":"Obstetric Service, Department Woman-Mother-Child, Centre Hospitalier Universitaire Vaudois (CHUV) ","role":"Collaborator"}],"copyright":"(c) 2022, Center for Primary Care and Public Health (Unisant\u00e9), University of Lausanne, Switzerland","funding_agencies":[{"name":"Swiss National Science Foundation","abbreviation":"SNSF","role":""}]},"distribution_statement":{"contact":[{"name":"C\u00e9line Racine (Repository administrator)","affiliation":"Center for Primary Care and Public Health (Unisant\u00e9), University of Lausanne, Switzerland","email":"dfri.data@unisante.ch","uri":""},{"name":"Clair, Carole","affiliation":"Department of ambulatory care (DDP), Center for Primary Care and Public Health (Unisant\u00e9), University of Lausanne, Switzerland","email":"carole.clair@unisante.ch","uri":""}]},"version_statement":{"version_date":""},"study_notes":"Depuis le 1er janvier 2019, la Policlinique m\u00e9dicale universitaire, l\u2019Institut universitaire de m\u00e9decine sociale et pr\u00e9ventive, l\u2019Institut universitaire romand de sant\u00e9 au travail, l\u2019association Promotion Sant\u00e9 Vaud et la Fondation vaudoise pour le d\u00e9pistage du cancer forment Unisant\u00e9, Centre universitaire de m\u00e9decine g\u00e9n\u00e9rale et sant\u00e9 publique \u00e0 Lausanne. www.unisante.ch","study_info":{"keywords":[{"keyword":"Smoking cessation","vocab":"","uri":""},{"keyword":"Type 2 diabetes","vocab":"","uri":""},{"keyword":"Behavioral intervention","vocab":"","uri":""},{"keyword":"Gender","vocab":"","uri":""}],"abstract":"Objectives\nThe aim of this study is to assess the efficacy of a smoking cessation intervention in a population of smokers with type 2 diabetes and to measure the metabolic impact of smoking cessation.\n\nDesign\nOpen label randomised controlled trial\n\nSetting\nAmbulatory care population recruited from a sanitary region in Switzerland from 2018 to 2020. \n\nParticipants\n48 participants were included, 19 women (39.6%) and 29 men (60.4%), their mean age was 61.8 years (SD 9.84), 28 completed the last follow-up. To be included, participants needed to speak and understand French, to be \u2265 18 years old, to have been diagnosed with type 2 diabetes and to have smoked > 100 cigarettes during their entire life and be currently smoking cigarettes. People not able to give informed consent and to follow the study procedure (due to dementia, psychological disorder, language problem), being enrolled in another smoking cessation study or program or in a multi-behavioural program that includes smoking cessation, planning to move out of Switzerland or pregnant or breastfeeding persons were excluded. \nParticipants were recruited from different centers, such as the ambulatory care clinic of the Center for Primary Care and Public Health (former PMU) in Lausanne and the Centre Hospitalier Universitaire Vaudois (CHUV) with patients hospitalized in medical or surgical wards. Participants were also enrolled from the diabetes\/endocrinology (EDM) department of CHUV and cardiology consultations, as well as from private practices of diabetes\/endocrinology specialists and general internists in the Lausanne area. Advertisements were also made on selected websites, newspapers and social networks, and recruitment also took place in pharmacies from Unisant\u00e9 and from the Lausanne area.\n\nInterventions\nThe intervention consisted in four individual behavioural counselling sessions over 12 weeks, conducted by trained research nurses, using motivational interviews and addressing diabetes and gender specificities. The control group had one short counselling session at baseline. Both groups had a follow-up visit at 6 and 12 months. \n\nPrimary and secondary outcome measures\nThe primary study outcome is continuous smoking abstinence validated by expired-air CO from week 12 to week 52. Secondary study outcomes are continuous and 7-day point-prevalence smoking abstinence at 12 and 26 weeks; change in motivation to quit and cigarette consumption; and change in HbA1c levels, body weight, waist circumference, and renal function after smoking cessation.\n\nResults\n48 participants were randomized, in the intervention (n=23) and control (n=25) groups. Follow-up rate was 77% at 3 months, 63% at 6 months and 58% at 12 months. The mean cigarettes consumption per day was 21.2 cig\/d, 62.5% planned to quit, 29.2% to reduce and 8.3% did not plan to quit. All participants had type 2 diabetes, with a mean duration of 11.9 years (DS 9.77), the mean BMI was 29.0 kg\/m2 (SD 4.06) and mean HbA1c 7.0% (SD 1.08). Continuous smoking abstinence from month 3 to month 6 was 4.3% (n=1) in the intervention and 4.0% (n=1) in the control group (p-value 0.95), and 0 and 4.0% (n=1) from month 3 to month 12 (p-value 0.33). At 3 month, 7-day point prevalence abstinence was 12.5% in the intervention group vs. 14.3% in the control group (p-value 0.88), and at 6 months 7.1% vs. 25% (p-value 0.19). Metabolic changes after smoking cessation could not be assessed given the small number of quitters.\n\nConclusions\nIn this study, stopped prematurely due to the slow recruitment, smoking cessation rate was low in both the intervention and control group without significant differences between groups. \nTrial registration \nClinicalTrials.gov NCT03426423 and FOPH portal SNCTP000002178","coll_dates":[{"start":"2017-01-07","end":"2021-04-06","cycle":""}],"nation":[{"name":"Switzerland","abbreviation":"CHE"}],"geog_coverage":"French-speaking part of Switzerland (Lausanne area)","analysis_unit":"Individual data, n=48","universe":"Participants to a research trial","data_kind":"Sociodemographic data, medical data, laboratory"},"method":{"data_collection":{"sampling_procedure":"48 participants were included, 19 women (39.6%) and 29 men (60.4%), their mean age was 61.8 years (SD 9.84), 28 completed the last follow-up. To be included, participants needed to speak and understand French, to be \u2265 18 years old, to have been diagnosed with type 2 diabetes and to have smoked > 100 cigarettes during their entire life and be currently smoking cigarettes. People not able to give informed consent and to follow the study procedure (due to dementia, psychological disorder, language problem), being enrolled in another smoking cessation study or program or in a multi-behavioural program that includes smoking cessation, planning to move out of Switzerland or pregnant or breastfeeding persons were excluded\n\t\t\n\t\tParticipants were recruited from different centers, such as the ambulatory care clinic of the Center for Primary Care and Public Health (former PMU) in Lausanne and the Centre Hospitalier Universitaire Vaudois (CHUV) with patients hospitalized in medical or surgical wards. Participants were also enrolled from the diabetes\/endocrinology (EDM) department of CHUV and cardiology consultations, as well as from private practices of diabetes\/endocrinology specialists and general internists in the Lausanne area. Advertisements were also made on selected websites, newspapers and social networks, and recruitment also took place in pharmacies from Unisant\u00e9 and from the Lausanne area.","coll_mode":"Face to face or telephone interviews with research nurses.\n\t\t\tThe data was entered into a REDCap survey by the research nurses on a tablet except for 2 questionnaires (ADDQoL and FFQ) which were auto-administered by participants on paper documents","research_instrument":"REDCap"}},"data_access":{"dataset_use":{"cit_req":"Carole Clair, Isabella Locatelli, Aur\u00e9lie Augsburger, C\u00e9line Varrin, Isabelle Jacot-Sadowski, Ivan Berlin, Anne Zanchi, Jardena J. Puder. Assessing the efficacy and impact of a personalised smoking cessation intervention among type 2 diabetic smokers: an open label randomised controlled trial (DISCGO-RCT). Center for Primary Care and Public Health (Unisant\u00e9), University of Lausanne, Switzerland. Version 1.0 of the licensed dataset (09\/2022), provided by the Unisant\u00e9 Research Data Repository. DOI:10.16909\/DATASET\/34","disclaimer":"The user of the data acknowledges that the original collector of the data, the authorized distributor of the data, and the relevant funding agency bear no responsibility for use of the data or for interpretations or inferences based upon such uses."}}},"schematype":"survey"}