- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07779161
Impact of Appointment Reminder Strategies on Smoking Cessation Clinic Attendance (NO-SHOW-NCC)
Effect of Reminder Strategies on No-Show Rates in a Nicotine Cessation Clinic: A Randomized Controlled Trial
The goal of this clinical trial is to learn whether different appointment reminder methods can improve attendance at an anti-smoking (smoking cessation) clinic among adult smokers.
The main question it aims to answer is:
"Which reminder method helps participants come to their scheduled smoking cessation clinic appointments most often?" Researchers will compare different appointment reminder methods with standard appointment scheduling to see if they help participants attend their clinic visits more often.
Participants will:
- Receive appointment reminders using different methods
- Come to their scheduled visits at a smoking cessation (anti-nicotine) clinic
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jagoda K Arendt
- Número de teléfono: +48 509 388 251
- Correo electrónico: jagoda.arendt@gumed.edu.pl
Ubicaciones de estudio
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Pomeranian Voivodeship
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Gdansk, Pomeranian Voivodeship, Polonia, 80-952
- University Clinical Centre
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Contacto:
- Łukasz W Balwicki, Assoc. Prof., DSc
- Número de teléfono: +48 606 369 656
- Correo electrónico: balwicki@gumed.edu.pl
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Investigador principal:
- Jagoda K Arendt
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age ≥ 18 years. Confirmed diagnosis of nicotine dependence (F17 according to the International Classification of Diseases, 10th Revision [ICD-10]) and active patient status at the Smoking Cessation Clinic.
- Provision of voluntary, written, informed consent to participate in the study and to be contacted by telephone or short text message.
- Ability to independently provide information and operate a mobile phone.
- At the time of study enrollment, attendance at an initial visit at the clinic.
Exclusion Criteria
- Age < 18 years.
- Lack of written, informed consent to participate in the study.
- Inability to independently understand the study procedures or provide responses (e.g., due to dementia or a language barrier).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Standard of care - Text message
Participants will receive a standard, automated text message reminding them of their scheduled appointment.
The message will be sent 1 day before the scheduled appointment.
The content of the message will be limited to logistical information (date, time, and location) and instructions on how to reschedule or cancel the appointment.
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Experimental: Text message and standard phone call
Participants will receive a text message (similar to Arm 1) one day before the appointment and, additionally, a phone call from a trained staff member 1-5 days before the appointment.
The conversation will follow a strictly standardized script limited solely to confirming the appointment date, without any motivational or therapeutic elements.
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Participants will receive a phone call from a trained staff member 1-5 days before the appointment.
The conversation will follow a strictly standardized script limited solely to confirming the appointment date, without any motivational or therapeutic elements.
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Experimental: Text message and phone call with MINDSPACE elements
Participants will receive a short text message (similar to Arm 1) and a phone call 1-5 days before their appointment. The conversation will follow a standardized script incorporating behavioral intervention (nudging) elements based on the MINDSPACE (Messenger, Incentives, Norms, Defaults, Salience, Priming, Affect, Commitments, Ego) framework. Key components of the script include:
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Participants will receive a phone call 1-5 days before their appointment. The conversation will follow a standardized script incorporating behavioral intervention (nudging) elements based on the MINDSPACE framework. Key components of the script include:
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Patient attendance at scheduled follow-up visit
Periodo de tiempo: At the second scheduled visit at the Nicotine Cessation Clinic (2-8 weeks after baseline).
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Primary Outcome: The primary outcome measure is a binary assessment of patient attendance (Present/Absent) at the scheduled second visit, which takes place 2-8 weeks after the initial visit, as determined by the physician's individual assessment.
Attendance will be verified on the day of the scheduled visit based on objective data recorded in the "CliniNET" hospital system.
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At the second scheduled visit at the Nicotine Cessation Clinic (2-8 weeks after baseline).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Impact of sociodemographic and clinical factors on patient attendance
Periodo de tiempo: at baseline and 2 to 8 weeks after enrollment
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Secondary Outcomes: Secondary analyses will include an assessment of the impact of sociodemographic and clinical factors based on tests routinely performed as part of a medical visit (age, sex, level of dependence according to the Fagerström Test for Nicotine Dependence (FTND)).
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at baseline and 2 to 8 weeks after enrollment
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- West R, Raw M, McNeill A, Stead L, Aveyard P, Bitton J, Stapleton J, McRobbie H, Pokhrel S, Lester-George A, Borland R. Health-care interventions to promote and assist tobacco cessation: a review of efficacy, effectiveness and affordability for use in national guideline development. Addiction. 2015 Sep;110(9):1388-403. doi: 10.1111/add.12998.
- Marcolino MS, Oliveira JAQ, D'Agostino M, Ribeiro AL, Alkmim MBM, Novillo-Ortiz D. The Impact of mHealth Interventions: Systematic Review of Systematic Reviews. JMIR Mhealth Uhealth. 2018 Jan 17;6(1):e23. doi: 10.2196/mhealth.8873.
- Kheirkhah P, Feng Q, Travis LM, Tavakoli-Tabasi S, Sharafkhaneh A. Prevalence, predictors and economic consequences of no-shows. BMC Health Serv Res. 2016 Jan 14;16:13. doi: 10.1186/s12913-015-1243-z.
- Wu Q, Zhang R, Tao L, Cai W, Cao X, Mao Z, Zhang J. Nudge theories and strategies influencing adult health behaviors and outcomes in COPD management: a systematic review. Front Public Health. 2024 Nov 5;12:1404590. doi: 10.3389/fpubh.2024.1404590. eCollection 2024.
- Wills L, Kenny PJ. Addiction-related neuroadaptations following chronic nicotine exposure. J Neurochem. 2021 Jun;157(5):1652-1673. doi: 10.1111/jnc.15356.
- Wang F, Li Y, Zhang C, Arbing R, Chen WT, Huang F. Evaluating digital nudge interventions for the promotion of cancer screening behavior: a systematic review and meta-analysis. BMC Med. 2025 Apr 14;23(1):214. doi: 10.1186/s12916-025-04028-8.
- Tang, B. (2022). Effect of SMS reminders on attendance rates for healthcare appointments: A systematic review & meta-analysis. Journal of Clinical Case Studies Reviews&Reports, 4(5), 1-8. https://doi.org/10.47363/JCCSR/2022(4)217
- Sakthisankaran, S. M., Sakthipriya, D., & Swamivelmanickam, M. (2024). Health risks associated with tobacco consumption in humans: An overview. Journal of Drug Delivery and Therapeutics, 14(5), 163-173. http://dx.doi.org/10.22270/jddt.v14i5.6523
- Rohrig B, du Prel JB, Wachtlin D, Kwiecien R, Blettner M. Sample size calculation in clinical trials: part 13 of a series on evaluation of scientific publications. Dtsch Arztebl Int. 2010 Aug;107(31-32):552-6. doi: 10.3238/arztebl.2010.0552. Epub 2010 Aug 9.
- Pęksa, J. W., & Dembe, K. (2021). Treatment of tobacco addiction - Outline of issues. Medycyna Ogólna i Nauki o Zdrowiu, 27(1), 32-39. https://doi.org/10.26444/monz/132652
- Picciotto MR, Kenny PJ. Mechanisms of Nicotine Addiction. Cold Spring Harb Perspect Med. 2021 May 3;11(5):a039610. doi: 10.1101/cshperspect.a039610.
- Michalek IM, Didkowska J, Koczkodaj P. First tobacco-free generation in Europe - A lost cause? Latest Global Youth Tobacco Survey data from Poland and the CEE region. J Cancer Policy. 2025 Sep;45:100601. doi: 10.1016/j.jcpo.2025.100601. Epub 2025 May 30.
- Jankowski M, Grudziaz-Sekowska J, Kaminska A, Sekowski K, Wrzesniewska-Wal I, Moczeniat G, Gujski M, Kaleta D, Ostrowski J, Pinkas J. A 2024 nationwide cross-sectional survey to assess the prevalence of cigarette smoking, e-cigarette use and heated tobacco use in Poland. Int J Occup Med Environ Health. 2024 Sep 10;37(3):271-286. doi: 10.13075/ijomeh.1896.02402. Epub 2024 Jun 14.
- Hwang AS, Atlas SJ, Cronin P, Ashburner JM, Shah SJ, He W, Hong CS. Appointment "no-shows" are an independent predictor of subsequent quality of care and resource utilization outcomes. J Gen Intern Med. 2015 Oct;30(10):1426-33. doi: 10.1007/s11606-015-3252-3. Epub 2015 Mar 17.
- Hrobjartsson A, Boutron I, Hopewell S, Moher D, Schulz KF, Collins GS, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne DR, Farmer AJ, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson DJ, Vohra S, White IR, Chan AW. SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials. BMJ. 2025 Apr 28;389:e081660. doi: 10.1136/bmj-2024-081660.
- Hoogsteder PH, Kotz D, van Spiegel PI, Viechtbauer W, Brauer R, Kessler PD, Kalnik MW, Fahim RE, van Schayck OC. The efficacy and safety of a nicotine conjugate vaccine (NicVAX(R)) or placebo co-administered with varenicline (Champix(R)) for smoking cessation: study protocol of a phase IIb, double blind, randomized, placebo controlled trial. BMC Public Health. 2012 Dec 6;12:1052. doi: 10.1186/1471-2458-12-1052.
- Hasvold PE, Wootton R. Use of telephone and SMS reminders to improve attendance at hospital appointments: a systematic review. J Telemed Telecare. 2011;17(7):358-64. doi: 10.1258/jtt.2011.110707. Epub 2011 Sep 20.
- Dantas LF, Fleck JL, Cyrino Oliveira FL, Hamacher S. No-shows in appointment scheduling - a systematic literature review. Health Policy. 2018 Apr;122(4):412-421. doi: 10.1016/j.healthpol.2018.02.002. Epub 2018 Feb 15.
- Bauerle WB, Reese V, Stoltzfus J, Benton A, Knipe J, Wilde-Onia R, Castillo R, Thomas P, Cipolla J, Braverman MA. Effect of Standardized Reminder Calls on Trauma Patient No-Show Rate. J Am Coll Surg. 2024 Feb 1;238(2):236-241. doi: 10.1097/XCS.0000000000000898. Epub 2023 Oct 20.
- Bahadir A, Iliaz S, Yurt S, Ortakoylu MG, Bakan ND, Yazar E. Factors affecting dropout in the smoking cessation outpatient clinic. Chron Respir Dis. 2016 May;13(2):155-61. doi: 10.1177/1479972316629953. Epub 2016 Feb 4.
- Alkomos MF, Mendez D, Mazzei-Pifano D, Shafeek F, Rodriguez C, Ali F, Banks C, Melki G, Michael P. Patients' reasons for missing scheduled clinic appointments and their solutions at a major urban-based academic medical center. J Community Hosp Intern Med Perspect. 2020 Sep 3;10(5):426-430. doi: 10.1080/20009666.2020.1796903.
Enlaces Útiles
- Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy, (February 2026), Poradnia Pomocy Palącym
- Telefoniczna poradnia pomocy palącym (TPPP) (2026 Luty), Jak rzucić palenie Telefoniczna poradnia pomocy palącym (TPPP)
- Uniwersyteckie Centrum Kliniczne w Gdańsku (2026 Luty) Uniwersyteckie Centrum Kliniczne Poradnia Antynikotynowa
- WHO. (2025). Tobacco.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KB/134/2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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