Mixed and Match vs One-size-fits-all
2022年3月22日 更新者：Dr Katherine Lam、The Hong Kong Polytechnic University
Mixed and Match Versus One-size-fits-all: A Randomized Controlled Trial of Self-determination Theory on a Menu of Smoking Cessation Options (SDTM) Among Adult Smokers
Most existing smoking cessation services are based on '5A's' and '5R's' models which are recognized by the World Health Organization as a standardized tool for smoking cessation.
While there are more techniques that are known to be effective and could be incorporated in existing smoking cessation interventions to further promote their effectiveness.
This study is to examine the effectiveness SDTM in assisting adult smokers in Hong Kong to quit.
調査の概要
詳細な説明
A randomized controlled trial (RCT) will be conducted.
One-hundred adult smokers aged 25 or above will be recruited from smoking hotspots in Hong Kong.
Participants in the intervention group will be contacted by our trained research assistant to receive a telephone counselling session at baseline.
Participants can choose to receive their own smoking cessation treatment options from our menu.
Control group participants will only receive a self-help quitting leaflet
研究の種類
介入
入学 (予想される)
500
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Katherine Lam, PhD
- 電話番号：27666420
- メール：kwkatlam@polyu.edu.hk
研究連絡先のバックアップ
- 名前：Eva Ho, PhD
- 電話番号：27666417
- メール：kyeva.ho@polyu.edu.hk
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
25年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- have smoking in the previous 30 days.
- be above 25 years old
- able to speak Cantonese and read Chinese
Exclusion Criteria:
- who are receiving current smoking cessation services
- report psychological disorders
- at risk of suicide
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：Mixed and Match
Participants can choose to receive their own smoking cessation treatment options from our menu.
|
Participants will receive a brief 15-minute counselling session based on the 5A's' and '5R's' models by our trained research assistant.
Participants will be able to choose their smoking cessation treatment options from our menu.
|
|
他の：Control
Participants will receive a self-help quitting leaflet
|
Participants in the control group will receive a self-help quitting leaflet issued by the TACO
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Self-reported abstinence at 6-month follow-up
時間枠：At 6-month follow-up
|
participants will be asked about their self-reported abstinence in the past 7 and 30 days
|
At 6-month follow-up
|
|
Biochemically validated abstinence
時間枠：At 6 months follow-up
|
validate the self-reported abstinence if the level of carbon monoxide in expired air was less than 4 parts per million and saliva cotinine level was less than100 ng/mL in parallel tests
|
At 6 months follow-up
|
|
Self-efficacy at 6-month follow-up
時間枠：At 6-month follow-up
|
Participants will be asked about their self-efficacy in quitting.
The score ranges from 0 to 10. Higher scores represent a higher self-efficacy.
|
At 6-month follow-up
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Screening rate
時間枠：at day 1
|
calculated as the number of smokers screened at smoking hotspots by the RA divided by number of smokers available
|
at day 1
|
|
Eligibility rate
時間枠：at day 1
|
calculated by dividing the number of smokers who are eligible by the number who are screened.
|
at day 1
|
|
Randomization rate
時間枠：at day 1
|
calculated by dividing the number of smokers who are randomized into intervention and control groups by those who provide consent.
|
at day 1
|
|
Attendance rate
時間枠：Immediately after the training workshop
|
calculated by dividing the number of smokers who complete the intervention by those who are randomized.
|
Immediately after the training workshop
|
|
Retention rate at 1-week follow-up
時間枠：At 1-week follow-up
|
calculated by dividing the number of smokers who remain in the study by those who are randomized
|
At 1-week follow-up
|
|
Retention rate at 1-month follow-up
時間枠：At 1-month follow-up
|
calculated by dividing the number of smokers who remain in the study by those who are randomized
|
At 1-month follow-up
|
|
Retention rate at 6-month follow-up
時間枠：At 6-month follow-up
|
calculated by dividing the number of smokers who remain in the study by those who are randomized
|
At 6-month follow-up
|
|
Retention rate at 3-month follow-up
時間枠：At 3-month follow-up
|
calculated by dividing the number of smokers who remain in the study by those who are randomized
|
At 3-month follow-up
|
|
Adherence to intervention protocol at 1-week follow-up
時間枠：At 1-week follow-up
|
calculated by dividing the number of smokers who follow and practice the chosen treatment options by those who are randomized
|
At 1-week follow-up
|
|
Adherence to intervention protocol at 1-month follow-up
時間枠：At 1-month follow-up
|
calculated by dividing the number of smokers who follow and practice the chosen treatment options by those who are randomized
|
At 1-month follow-up
|
|
Adherence to intervention protocol at 3-month follow-up
時間枠：At 3-month follow-up
|
calculated by dividing the number of smokers who follow and practice the chosen treatment options by those who are randomized
|
At 3-month follow-up
|
|
Adherence to intervention protocol at 6-month follow-up
時間枠：At 6-month follow-up
|
calculated by dividing the number of smokers who follow and practice the chosen treatment options by those who are randomized
|
At 6-month follow-up
|
|
Complete rate at 1-week follow-up
時間枠：At 1-week follow-up
|
calculated by dividing the number of smokers who returned questionnaires by the number of questionnaires distributed
|
At 1-week follow-up
|
|
Complete rate at 1-month follow-up
時間枠：At 1-month follow-up
|
calculated by dividing the number of smokers who returned questionnaires by the number of questionnaires distributed
|
At 1-month follow-up
|
|
Complete rate at 3-month follow-up
時間枠：At 3-month follow-up
|
calculated by dividing the number of smokers who returned questionnaires by the number of questionnaires distributed
|
At 3-month follow-up
|
|
Complete rate at 6-month follow-up
時間枠：At 6-month follow-up
|
calculated by dividing the number of smokers who returned questionnaires by the number of questionnaires distributed
|
At 6-month follow-up
|
|
Missing data at 1-week follow-up
時間枠：At 1-week follow-up
|
calculated as the percentage of missing values in the dataset
|
At 1-week follow-up
|
|
Missing data at 1-month follow-up
時間枠：At 1-month follow-up
|
calculated as the percentage of missing values in the dataset
|
At 1-month follow-up
|
|
Missing data at 3-month follow-up
時間枠：At 3-month follow-up
|
calculated as the percentage of missing values in the dataset
|
At 3-month follow-up
|
|
Missing data at 6-month follow-up
時間枠：At 6-month follow-up
|
calculated as the percentage of missing values in the dataset
|
At 6-month follow-up
|
|
Adverse events at 6-month follow-up
時間枠：At 6-month follow-up
|
Participants will report any unfavorable and unintended events
|
At 6-month follow-up
|
|
Adverse events at 1-week follow-up
時間枠：At 1-week follow-up
|
Participants will report any unfavorable and unintended events
|
At 1-week follow-up
|
|
Adverse events at 1-month follow-up
時間枠：At 1-month follow-up
|
Participants will report any unfavorable and unintended events
|
At 1-month follow-up
|
|
Adverse events at 3-month follow-up
時間枠：At 3-month follow-up
|
Participants will report any unfavorable and unintended events
|
At 3-month follow-up
|
|
Self-reported abstinence at 1-week follow-up
時間枠：At 1-week follow-up
|
Participants will be asked about their self-reported abstinence in the past 7 and 30 days
|
At 1-week follow-up
|
|
Self-reported abstinence at 1-month follow-up
時間枠：At 1-month follow-up
|
participants will be asked about their self-reported abstinence in the past 7 and 30 days
|
At 1-month follow-up
|
|
Self-reported abstinence at 3-month follow-up
時間枠：At 3-month follow-up
|
participants will be asked about their self-reported abstinence in the past 7 and 30 days
|
At 3-month follow-up
|
|
Self-efficacy at 1-week follow-up
時間枠：at 1-week follow-up
|
Participants will be asked about their self-efficacy in quitting.
The score ranges from 0 to 10. Higher scores represent a higher self-efficacy.
|
at 1-week follow-up
|
|
Self-efficacy at 1-month follow-up
時間枠：at 1-month follow-up
|
Participants will be asked about their self-efficacy in quitting.
The score ranges from 0 to 10. Higher scores represent a higher self-efficacy.
|
at 1-month follow-up
|
|
Self-efficacy at 3-month follow-up
時間枠：at 3-month follow-up
|
Participants will be asked about their self-efficacy in quitting.
The score ranges from 0 to 10. Higher scores represent a higher self-efficacy.
|
at 3-month follow-up
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Katherine Lam, PhD、The Hong Kong Polytechnic University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (予想される)
2022年7月1日
一次修了 (予想される)
2023年12月31日
研究の完了 (予想される)
2023年12月31日
試験登録日
最初に提出
2021年5月18日
QC基準を満たした最初の提出物
2022年3月22日
最初の投稿 (実際)
2022年3月28日
学習記録の更新
投稿された最後の更新 (実際)
2022年3月28日
QC基準を満たした最後の更新が送信されました
2022年3月22日
最終確認日
2022年3月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- SDTM-adult
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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