Behaviour Change in Context to Contain the Spread of COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 425
- 试验地点
- 2
- 主要终点
- Average frequency of correct hand hygiene behaviour at key times
研究概览
简要总结
Project BECCCS (=Behavior Change in Context to Contain the Spread of COVID-19) aims to optimise and test a behaviour change intervention to promote correct hand hygiene at key times in the short and long term.
The study's specific aims are:
- Optimisation phase: Identify the most effective combination and sequence of three different intervention modules (habit, motivation, social norms), and to assess usability and fidelity measures in order to optimise the intervention
- Evaluation phase: Test the final intervention against an active control group (basic app content including "Federal Office of Public Health" advice)
详细描述
Study design:
In this study, the MOST methodology (multiphase optimization strategy; Collins et al., 2014) will be applied. First, the most effective intervention components for specific target groups will be determined, which is called the optimisation phase. To this end, the investigators run a parallel randomized trial that investigates all combinations of three interventions modules (= 9 combinations) in terms of its usability and its effectiveness.
To collect in-depth information about usability and feasibility, the investigators will additionally run a qualitative survey with a small subsample of the trial.
After this optimisation phase, the intervention's effectiveness will be tested against an active control group in a randomized controlled trial, which is called the evaluation phase.
For the optimisation phase, participants will be randomly assigned to one of nine conditions. All participants are randomized into one of nine intervention group in a 1:1:1:1:1:1:1:1 ratio. For the randomization, an even randomization procedure is applied using Qualtrics. Because the randomization is even, the probability is fixed if the number of the participants can be divided by 9, it means that at the end the investigators will have exactly even number of participants in each group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be at least 18 years old
- •Have signed an electronically written informed consent (online) form to participate in the study
- •Own a smartphone with mobile access to the internet
- •Be proficient in the German language to the degree that they understand the contents and instructions of the study.
排除标准
- 未提供
结局指标
主要结局
Average frequency of correct hand hygiene behaviour at key times
时间窗: Day 33 (after module 2)
First, participants indicate, whether they experienced key times, e.g. arriving home, after using the toilet, which require to wash or disinfect hands since the last questionnaire. Participants will then be asked how many times they correctly washed or disinfected hands at the indicated key times. The response options are 0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = always. Participants receive 5 questionnaires during a diary day. People attend a diary day after module 1 and after module 2. The frequencies across the 5-times daily diaries will be averaged to indicate the average frequency by which participants correctly performed hand hygiene at key times that day (scale ranging from 0 to 4).
次要结局
- Frequency of hand hygiene behaviour at key times, but not correctly(Day 16 (after module 1) and day 33 (after module 2))
- Self-reported behavioural intention(Day 17 (main survey T2) and day 34 (main survey T3))
- Mean score of three self-reported injunctive norm items(Day 17 (main survey T2) and day 34 (main survey T3))
- Mean score of three self-reported action planning items(Day 17 (main survey T2) and day 34 (main survey T3))
- Mean score of eight self-reported self-efficacy items(Day 17 (main survey T2) and day 34 (main survey T3))
- Mean score of self-reported fife risk perception items(Day 17 (main survey T2) and day 34 (main survey T3))
- Mean score of eight self-reported outcome-expectancies items(Day 17 (main survey T2) and day 34 (main survey T3))
- Mean score of four self-reported coping planning items(Day 17 (main survey T2) and day 34 (main survey T3))
- Habit strength assessed with the self-report habit index (SRHI)(Day 17 (main survey T2) and day 34 (main survey T3))
- Mean score of two self-reported descriptive norm items(Day 17 (main survey T2) and day 34 (main survey T3))
- Mean score of intervention fidelity items(Day 17 (main survey T2) and day 34 (main survey T3))
- Self-reported flu-like infection symptoms(Day 17 (main survey T2) and day 34 (main survey T3))
- Self-reported statement of the occurrences of Covid-19.(Day 17 (main survey T2) and day 34 (main survey T3))
- Mean score of six self-reported attitude items(Day 17 (main survey T2) and day 34 (main survey T3))
- Mean score of three self-reported action control items(Day 17 (main survey T2) and day 34 (main survey T3))
- Intervention usability using the System Usability Scale (SUS)(Day 17 (main survey T2) and day 34 (main survey T3))
- Satisfaction using the ZUF-8 (Original Englische Version CSQ-8)(Day 17 (main survey T2) and day 34 (main survey T3))
- User engagement assessed with the DBCI Engagement Scale(Day 17 (main survey T2) and day 34 (main survey T3))