- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Jagoda K Arendt
- Telefonní číslo: +48 509 388 251
- E-mail: jagoda.arendt@gumed.edu.pl
Studijní místa
-
-
Pomeranian Voivodeship
-
Gdansk, Pomeranian Voivodeship, Polsko, 80-952
- University Clinical Centre
-
Kontakt:
- Łukasz W Balwicki, Assoc. Prof., DSc
- Telefonní číslo: +48 606 369 656
- E-mail: balwicki@gumed.edu.pl
-
Vrchní vyšetřovatel:
- Jagoda K Arendt
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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).
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Žádný zásah: 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.
|
|
|
Experimentální: 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.
|
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.
|
|
Experimentální: 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:
|
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:
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Patient attendance at scheduled follow-up visit
Časové okno: At the second scheduled visit at the Nicotine Cessation Clinic (2-8 weeks after baseline).
|
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.
|
At the second scheduled visit at the Nicotine Cessation Clinic (2-8 weeks after baseline).
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Impact of sociodemographic and clinical factors on patient attendance
Časové okno: at baseline and 2 to 8 weeks after enrollment
|
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)).
|
at baseline and 2 to 8 weeks after enrollment
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- 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.
Užitečné odkazy
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- KB/134/2026
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .