- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT04599049
Evaluation Study on Smoke-free Teens Programme 2020-2021
The objectives are:
i. To evaluate Smoke-free Teens' change in knowledge on smoking hazards, attitudes towards smoking, tobacco control and smoking cessation, and practices for promoting smoking prevention and cessation, ii. To evaluate the process and quality of smoke-free programmes organized by the Smoke-free Teens in their schools/community, and iii. To measure the number of people reached in the smoke-free programmes organized by the Smoke-free Teens.
A tanulmány áttekintése
Állapot
Körülmények
Részletes leírás
Participants Youth between Form 1 and 4 or aged 14 to 18 in the school academic year 2019-2020 will be nominated by secondary schools, youth centres and uniform groups to participate in the Smoke-free Teens Programme 2020-2021.
Outcomes The primary outcomes include the change in (1) knowledge on smoking hazards, (2) attitudes towards smoking, tobacco control and smoking cessation, (3) practices for promoting smoking prevention and cessation, and (4) the Smoke-free Teens' satisfaction on the training camp.
The secondary outcomes are (1) the number of people participated in the school- or community-based smoke-free programmes organised by the Smoke-free Teens, and (2) the number of smokers advised and referred to existing smoking cessation services by the Smoke-free Teens.
Smoke-free Teens Programme The Smoke-free teens will join six sessions of online classes via an e-platform in October 2020 and followed by virtual training day camps through Zoom in two days in December 2020 organized by Hong Kong Council on Smoking and Health (COSH). The online classes will educate students the knowledge on smoking hazards, tobacco control and smoking cessation.In addition, the teens will be taught how to deliver a brief smoking cessation intervention using the "AWARD" Model: 1) Ask about smoking, 2) Warn the smokers that at least half will be killed by smoking, 3) Advise to quit (reduce) as soon as possible, 4) Refer to cessation clinics or hotlines, and 5) Do it again until the smokers quit. By the end of the training camp, the teens should be confident and competent in delivering the brief smoking cessation intervention to smokers. After the online classes, the teens will then break down into groups to organize smoke-free programmes in their schools or in the community.
Survey instrument A structured questionnaire designed by the smoking cessation team, School of Nursing, the University of Hong Kong will be used to evaluate the training camp. The questionnaire covers four areas, including (1) knowledge on smoking hazards, (2) attitudes towards smoking, tobacco control and smoking cessation, (3) practices for promoting smoking prevention and cessation, and (4) self-efficacy to deliver smoking cessation advices. The items of the questionnaire have been adopted and modified from previous studies on smoking cessation, with well-established psychometric properties. A process evaluation form (Appendix 4) will also be developed by the smoking cessation team to assess how the teens satisfy with the online classes and training camp, and to determine whether the content of online classes and training camp meets the learning needs and expectations of the teens. Table 1 shows the items that will be asked at each time point.
To evaluate the smoke-free programmes organized after the training camp, each group of the Smoke-free Teens will be required to submit a written proposal to COSH. In addition, a final report that contains the information about the number of people reached by the programmes, publicity, and the process and outcomes of the programmes, will be submitted for review.
Data collection Data collection will be conducted by COSH. All Smoke-free Teens will be invited to respond to the structured questionnaire at baseline (T1), immediately after the online classes (T2), and 3 months later (T4). In addition, they will be asked to complete a process evaluation form immediately after the training camp (T3). Comments and suggestions provided by the teens in the process evaluation form will be taken into account for future improvement of the training camp. In addition, each group of teens will have to submit the written proposal and final report regarding the smoke-free programme to COSH at 3 months (T4), respectively.
Statistical analysis The Statistical Package for Social Science (SPSS: Version 23; SPSS Inc., Chicago, IL, USA) for Windows will be employed to analyze the data. Descriptive statistics will be used to describe the demographic characteristics of the Smoke-free Teens. Paired samples t-test and Wilcoxon signed-rank test will be conducted to assess the change in knowledge, attitudes and practices of the Smoke-free Teens regarding smoking, tobacco control and smoking cessation before and after the training camp. To evaluate the smoke-free programmes organized by the Smoke-free Teens after the training camp, descriptive statistics will be used to report the number of people reached by the programmes, publicity, and the process and outcomes of the programmes.
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
-
-
HK
-
Hong Kong, HK, Hong Kong
- William Ho-cheung Li
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
Inclusion Criteria: be able to communicate with Cantonese, nominated by secondary schools, youth centres and uniform groups -
Exclusion Criteria:
-
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Egészségügyi szolgáltatások kutatása
- Kiosztás: N/A
- Beavatkozó modell: Egyetlen csoportos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Egyéb: six sessions of online classes and virtual training day camps through Zoom in two days
The Smoke-free teens will join six sessions of online classes via an e-platform in October 2020 and followed by virtual training day camps through Zoom in two days in December 2020 organized by COSH. The online classes will educate students the knowledge on smoking hazards, tobacco control and smoking cessation. In addition, the teens will be taught how to deliver a brief smoking cessation intervention using the "AWARD" Model. After the online classes, the teens will then break down into groups to organize smoke-free programmes in their schools or in the community. All Smoke-free Teens will be invited to respond to the structured questionnaire at baseline (T1), immediately after the online classes (T2), and 3 months later (T4). They will be asked to complete a process evaluation form immediately after the training camp (T3). Each group of teens will have to submit the written proposal and final report regarding the smoke-free programme to COSH at 3 months (T4), respectively. |
The Smoke-free teens will join six sessions of online classes via an e-platform in October 2020 and followed by virtual training day camps through Zoom in two days in December 2020 organized by COSH. The online classes will educate students the knowledge on smoking hazards, tobacco control and smoking cessation. In addition, the teens will be taught how to deliver a brief smoking cessation intervention using the "AWARD" Model. After the online classes, the teens will then break down into groups to organize smoke-free programmes in their schools or in the community. All Smoke-free Teens will be invited to respond to the structured questionnaire at baseline (T1), immediately after the online classes (T2), and 3 months later (T4). They will be asked to complete a process evaluation form immediately after the training camp (T3). Each group of teens will have to submit the written proposal and final report regarding the smoke-free programme to COSH at 3 months (T4), respectively. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Alapszintű ismeretek a dohányzás veszélyeiről
Időkeret: Alapvonal
|
A dohányzástól mentes tizenévesek dohányzási veszélyekkel kapcsolatos alapszintű tudását a „dohányzás veszélyeivel kapcsolatos ismeretek” skálával mérik egy önbevallásos strukturált kérdőívben.
|
Alapvonal
|
|
The change in knowledge on smoking hazards
Időkeret: Baseline, immediately after the online classes and 3 months
|
The change in Smoke-free Teens' knowledge on smoking hazards immediately after the online classes and 3 months will be measured by the scale called "knowledge on smoking hazards" in a self-reporting structured questionnaire.
|
Baseline, immediately after the online classes and 3 months
|
|
A dohányzással, a dohányzás visszaszorításával és a dohányzás abbahagyásával kapcsolatos attitűdök kiindulási szinten
Időkeret: Alapvonal
|
A dohányzásmentes tizenévesek dohányzással, dohányzásszabályozással és dohányzásról való leszokással kapcsolatos attitűdjét alapszinten a „dohányzáshoz, a dohányzás visszaszorításához és a dohányzás abbahagyásához” nevezett skála méri egy önbevallásos strukturált kérdőívben.
|
Alapvonal
|
|
The change in attitudes towards smoking, tobacco control and smoking cessation
Időkeret: Baseline, immediately after the online classes and 3 months
|
The change in Smoke-free Teens' attitudes towards smoking, tobacco control and smoking cessation immediately after the online classes and 3 months will be measured by the scale called "attitudes towards smoking, tobacco control and smoking cessation" in a self-reporting structured questionnaire.
|
Baseline, immediately after the online classes and 3 months
|
|
Practices for promoting smoking prevention and cessation at baseline level
Időkeret: Baseline
|
Smoke-free Teens' practices for promoting smoking prevention and cessation at baseline level will be measured by the scale called "practices for promoting smoking prevention and cessation" in a self-reporting structured questionnaire
|
Baseline
|
|
The change in practices for promoting smoking prevention and cessation
Időkeret: Baseline and 3 months
|
The change in Smoke-free Teens' practices for promoting smoking prevention and cessation after 3 months will be measured by the scale called "practices for promoting smoking prevention and cessation" in a self-reporting structured questionnaire.
|
Baseline and 3 months
|
|
Önhatékonyság a dohányzás abbahagyására vonatkozó tanácsok kiindulási szinten történő nyújtásához
Időkeret: Alapvonal
|
A dohányzásról való leszokásról szóló tanácsokat a dohányzásról való leszokásról szóló önhatékonyságnak nevezett skálán mérik egy önbevallást készítő strukturált kérdőívben a dohányzásmentes tizenévesek dohányzásról való leszokásról szóló tanácsaival kapcsolatos önhatékonysága.
|
Alapvonal
|
|
The change in self-efficacy to deliver smoking cessation advices
Időkeret: Baseline, immediately after the online classes and 3 months
|
The change in Smoke-free Teens' self-efficacy to deliver smoking cessation advices immediately after the training camp, after after the online classes and 3 months will be measured by the scale called "self-efficacy to deliver smoking cessation advices" in a self-reporting structured questionnaire.
|
Baseline, immediately after the online classes and 3 months
|
|
Az edzőtábor folyamatértékelése
Időkeret: közvetlenül az edzőtábor után
|
A dohányzásmentes tizenévesek visszajelzéseit és az edzőtáborral kapcsolatos véleményét közvetlenül az edzőtábor után a „folyamatértékelés”-nek nevezett skálával mérjük egy önbeszámoló strukturált kérdőívben.
|
közvetlenül az edzőtábor után
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
The number of people participated in the school- or community-based smoke-free programmes organized by the Smoke-free Teens after the training camp
Időkeret: 3 months
|
After the online classes, the teens will be required to organize smoke-free programmes in their schools or communities so as to deliver brief smoking cessation intervention and to promote smoke-free messages in their schools and communities.
The number of people participated in these school- or community-based smoke-free programmes will be measured by a final report submitted by the teens that indicate the relevant information.
|
3 months
|
|
The number of smokers advised and referred to existing smoking cessation
Időkeret: 3 months
|
After the online classes, the teens will organize smoke-free programmes in their schools or in the communities so as to deliver brief smoking cessation intervention and to promote smoke-free messages in their schools and communities.
The number of smokers the teens advised and referred to existing smoking cessation services during these school- or community-based smoke-free programmes will be measured by a final report submitted by the teens that indicate the relevant information.
|
3 months
|
Együttműködők és nyomozók
Szponzor
Nyomozók
- Kutatásvezető: William LI, Phd, School of Nursing, The University of Hong Kong
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
Egyéb vizsgálati azonosító számok
- Smoke-free Teens 2020
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
IPD megosztási időkeret
IPD-megosztási hozzáférési feltételek
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .