Effectiveness of a telephone-based intervention for smoking cessation in patients with severe mental disorders : Study protocol for a randomized controlled trial

Autor: Ballbè, M., Martínez, C., Feliu, A., Torres, N., Nieva, Gemma, Pinet, C., Raich, A., Mondon, S., Barrio, P., Hernández-Ribas, R., Vicens, J., Costa, Silvia, Vilaplana, J., Alaustre, L., Vilalta, E., Blanch, R., Subirà, S., Bruguera, Eugeni, Suelves, J. M., Guydish, J., Fernández, E., Universitat Autònoma de Barcelona
Přispěvatelé: Institut Català de la Salut, [Ballbè M] Tobacco Control Unit, Cancer Control and Prevention Program, Institut Català d'Oncologia-ICO, L'Hospitalet de Llobregat, Barcelona, Spain. Cancer Control and Prevention Group, Institut d'Investigació Biomèdica de Bellvitge-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain. Addictions Unit, Institute of Neurosciences, Hospital Clínic de Barcelona, Barcelona, Spain. [Martínez C] Tobacco Control Unit, Cancer Control and Prevention Program, Institut Català d'Oncologia-ICO, L'Hospitalet de Llobregat, Barcelona, Spain. Cancer Control and Prevention Group, Institut d'Investigació Biomèdica de Bellvitge-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain. Medicine and Health Sciences School, Universitat Internacional de Catalunya, Sant Cugat del Valles, Barcelona, Spain. Department of Clinical Sciences, School of Medicine, Universitat de Barcelona, L'Hospitalet del Llobregat, Barcelona, Spain. [Feliu A] Tobacco Control Unit, Cancer Control and Prevention Program, Institut Català d'Oncologia-ICO, L'Hospitalet de Llobregat, Barcelona, Spain. Cancer Control and Prevention Group, Institut d'Investigació Biomèdica de Bellvitge-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain. Department of Clinical Sciences, School of Medicine, Universitat de Barcelona, L'Hospitalet del Llobregat, Barcelona, Spain. [Torres N] 061 CatSalut Respon, Sistema d'Emergències Mèdiques, L'Hospitalet de Llobregat, Barcelona, Spain. [Nieva G] Servei de Psiquiatria, Hospital Universitari Vall d'Hebron, Barcelona, Spain. Vall d’Hebron Institut de Recerca, Barcelona, Spain. Departament de Medicina, Universitat Autònoma de Barcelona, Barcelona, Spain. [Pinet C] Addictive Behaviors Unit, Psychiatry Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. [Bruguera E] Servei de Psiquiatria, Hospital Universitari Vall d'Hebron, Barcelona, Spain. Vall d’Hebron Institut de Recerca, Barcelona, Spain. Departament de Medicina, Universitat Autònoma de Barcelona, Barcelona, Spain., Hospital Universitari Vall d'Hebron, Universitat de Barcelona, Vall d'Hebron Barcelona Hospital Campus
Rok vydání: 2019
Předmět:
Male
Other subheadings::/methods [Other subheadings]
Personas::Personas con Discapacidad::Enfermos Mentales [DENOMINACIONES DE GRUPOS]
Instalaciones para Atención de Salud
Recursos Humanos y Servicios::Servicios de Salud::Servicios Médicos de Urgencia::Líneas Directas [ATENCIÓN DE SALUD]
medicine.medical_treatment
Smoking Prevention
Mental disorders
Smoking cessation
Cardiovascular
law.invention
Pathological psychology
Study Protocol
0302 clinical medicine
Otros calificadores::/métodos [Otros calificadores]
Medicine
Multicenter Studies as Topic
Pharmacology (medical)
Características de los Estudios::Estudio Clínico::Ensayo Clínico [CARACTERÍSTICAS DE PUBLICACIONES]
media_common
Cancer
education.field_of_study
Smoking Cessation Agents
Tobacco Use Disorder
Tabaquisme - Tractament
Clinical trial
Estudi de casos
Health Care Facilities
Manpower
and Services::Health Services::Emergency Medical Services::Hotlines [HEALTH CARE]
Number needed to treat
Respiratory
lcsh:Medicine (General)
medicine.medical_specialty
media_common.quotation_subject
Clinical Trials and Supportive Activities
Clinical Sciences
03 medical and health sciences
características del estudio::estudio clínico::ensayo clínico [CARACTERÍSTICAS DE PUBLICACIONES]
Clinical Research
Study Characteristics::Clinical Study::Clinical Trial [PUBLICATION CHARACTERISTICS]
Humans
education
Persons::Disabled Persons::Mentally Ill Persons [NAMED GROUPS]
Aged
Tobacco Smoke and Health
Prevention
Odds ratio
Abstinence
Prevention of disease and conditions
Psicopatologia
personas::personas con discapacidad::personas con enfermedad mental [DENOMINACIONES DE GRUPOS]
3.1 Primary prevention interventions to modify behaviours or promote wellbeing
Telèfon
030217 neurology & neurosurgery
Comparative Effectiveness Research
and promotion of well-being
Time Factors
Medicine (miscellaneous)
Cardiorespiratory Medicine and Haematology
Randomized controlled trial
law
Single-Blind Method
030212 general & internal medicine
lcsh:R5-920
Cardiovascular Medicine And Haematology
Conducta y Mecanismos de Conducta::Conducta::Conductas Relacionadas con la Salud::Cese del Hábito de Fumar [PSIQUIATRÍA Y PSICOLOGÍA]
Smoking
Substance Abuse
Middle Aged
Combined Modality Therapy
Stroke
Quitline
Treatment Outcome
Mental Health
Behavior and Behavior Mechanisms::Behavior::Health Behavior::Smoking Cessation [PSYCHIATRY AND PSYCHOLOGY]
Female
Protocols clínics
Adult
Quitlines
Adolescent
Population
Assessorament psicològic per telèfon
Young Adult
Patient Education as Topic
General & Internal Medicine
Pragmatic Clinical Trials as Topic
Tobacco
Tractament del tabaquisme
business.industry
instalaciones
servicios y personal de asistencia sanitaria::servicios de salud::servicios médicos de urgencia::líneas directas [ATENCIÓN DE SALUD]
Mental health
Brain Disorders
Medical protocols
Telephone
Good Health and Well Being
Cardiovascular System & Hematology
Spain
Physical therapy
Case studies
business
Malalties mentals
conducta y mecanismos de la conducta::conducta::conducta sanitaria::cese del hábito de fumar [PSIQUIATRÍA Y PSICOLOGÍA]
Assaigs clínics
Zdroj: Dipòsit Digital de Documents de la UAB
Universitat Autònoma de Barcelona
Trials, Vol 20, Iss 1, Pp 1-11 (2019)
Dipòsit Digital de la UB
Universidad de Barcelona
Scientia
Trials, vol 20, iss 1
Repositorio Abierto de la UdL
Universitad de Lleida
Recercat. Dipósit de la Recerca de Catalunya
instname
Trials
r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
Recercat: Dipósit de la Recerca de Catalunya
Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Ballbè, M; Martínez, C; Feliu, A; Torres, N; Nieva, G; Pinet, C; et al.(2019). Effectiveness of a telephone-based intervention for smoking cessation in patients with severe mental disorders: Study protocol for a randomized controlled trial. Trials, 20(1), 38. doi: 10.1186/s13063-018-3106-5. UC Office of the President: Research Grants Program Office (RGPO). Retrieved from: http://www.escholarship.org/uc/item/1md332th
ISSN: 1745-6215
DOI: 10.1186/s13063-018-3106-5.
Popis: Background Up to 75% of inpatients with mental disorders smoke, and their life expectancy is decreased by up to 25 years compared to the general population. Hospitalized patients without monitoring after discharge quickly return to prehospitalization levels of tobacco use. The aim of the 061 QuitMental study is to assess the effectiveness of a multicomponent and motivational telephone-based intervention to stop smoking through a quitline addressed to smokers discharged from mental health hospital wards. Methods A pragmatic randomized controlled trial, single blinded, will include 2:1 allocation to the intervention group (IG) and the control group (CG). The IG will receive telephone assistance to quit smoking (including psychological and psychoeducational support, and pharmacological treatment advice if required) proactively for 12 months, and the CG will receive only brief advice after discharge. The sample size, calculated with an expected difference of 15 points on smoking abstinence between groups (IG, 20% and CG, 5%), α = 0.05, β = 0.10, and 20% loss, will be 334 participants (IG) and 176 participants (CG). Participants are adult smokers discharged from psychiatric units of five acute hospitals. Measurements include dependent variables (self-reported 7-day point prevalence smoking abstinence (carbon monoxide verified), duration of abstinence, number of quit attempts, motivation, and self-efficacy to quit) and independent variables (age, sex, and psychiatric diagnoses). In data analysis, IG and CG data will be compared at 48 h and 1, 6, and 12 months post discharge. Multivariate logistic regression (odds ratio; 95% confidence interval) of dependent variables adjusted for potential confounding variables will be performed. The number needed to treat to achieve one abstinence outcome will be calculated. We will compare the abstinence rate of enrolled patients between groups. Discussion This trial evaluates an innovative format of a quitline for smokers with severe mental disorders regardless of their motivation to quit. If effective, the pragmatic nature of the study will permit transfer to routine clinical practice in the National Health System. Trial registration ClinicalTrials.gov, NCT03230955. Registered on 24 July 2017. Electronic supplementary material The online version of this article (10.1186/s13063-018-3106-5) contains supplementary material, which is available to authorized users.
Databáze: OpenAIRE
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