Hand HygieneNCT04830761
Behavior Change in Context to Contain the Spread of COVID-19
A study testing Motivation, Habit and Social in people with Hand Hygiene, run by University of Bern at 1 site in Switzerland.
Trial summary
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: 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hand Hygiene
- What is being tested?
- Motivation, Habit and Social
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 425 participants
- Where
- 1 siteSwitzerland
- Study dates
- 26 Mar 2021to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Behaviour Change in Context to Contain the Spread of COVID-19
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)
Read the detailed description
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.
In the evaluation phase, the optimised intervention from the optimisation phase will be tested in an RCT. To this end, participants will be randomly assigned to one of two conditions: final intervention vs. active control group. The active control group has access to the app, receives the basic module to test the effect of the final intervention, will answer the three questionnaires (pre-test, post-test, follow-up), and the short questionnaires (diary days).
Recruitment and informed consent procedure:
The sample will be recruited via Facebook and Instagram. Those who click on the link of the campaign will lead to a landing page with the relevant study information. Here, participants read the study info and enter their e-mail address. When they click on "send", an info box explains that an email has been sent including the link to the actual study.
In the mail, the participants can access via link to an eligibility and consent survey with detailed information about the nature of the study (=optimization and evaluation phase), its purpose, the procedures involved, the expected duration, the potential risks and benefits, any discomfort it may entail and finally an e-consent form to give consent to the study electronically. If people meet all inclusion criteria, the participants can directly sign with the mouse (on computer) or finger (on mobile device) the consent form.
After the participants agree to participate in the study, they receive a registration code via e-Mail to participate in the study as well as a signed copy of the consent form (at the latest of one week after giving consent electronically).
In the mail, the participants are guided to download the app "soapp" from their app store with the registration code. After downloading the app, they have to register and tip in the registration code. After that, they start with the first questionnaire T1 (optimization phase) or pre-test (evaluation phase).
Study procedure:
The duration of the study is 5 weeks (optimisation phase) plus a 6-month follow-up in the evaluation phase. Each participant receives two different intervention modules which each last 2 weeks.
After downloading the study app, the participants receive the first baseline questionnaire (T1 or pre-test).
Optimization phase: The day after T1, people attend a diary day. The diary day includes five 1-minute-questionnaires during one day. People will be informed that the intervention starts on the subsequent day after the diary day. The intervention will take four weeks and includes two modules. During the first module, people will attend another diary day at the end of each week (2 in total during one module). On the subsequent day of the last dairy day of the first module, people will receive the second questionnaire (T2). After T2, the second intervention module follows in the same structure: The participants follow the instructions of the intervention and their hand hygiene behaviour is surveyed on the last day of each week using the short questionnaire within the diary day. A day after the participants completed the last diary day and with that the second module, they receive the last questionnaire (T3). Additionally, to the normal questionnaire, the participants can indicate at T3, whether they are willing to take part in a qualitative survey. Here, people will be interviewed via telephone by a study member. This interview will take around 30 minutes for the participants, where they will be asked questions about the usability of the app and their experience with the intervention modules. This information will be used to improve the study app before starting with the evaluation phase. By the end of the study, the participants will have completed three questionnaires (T1-T3) and five short-questionnaires.
Evaluation phase: The day after the pre-test questionnaire, people attend a diary day to assess their previous hand hygiene behaviour. People will be informed that the intervention starts on the subsequent day after the diary day. The intervention will run for four weeks. During these four weeks, people will attend another diary day at the end of each week (4 in total during the total intervention). A day after the last diary day of the intervention, participants are asked to fill in the second questionnaire (post-test). In the evaluation phase, the participants will receive a six-month follow-up. They will first attend a diary day after 6 months after the intervention started and will then receive the follow-up questionnaire the subsequent day. By the end of the study, the participants will have completed three questionnaires (pre-test, post-test, follow-up) and six short-questionnaires.
Hypotheses:
Optimisation:
Hyp.1: The intervention groups show a significant increase in correct hand hygiene behaviour at key times (T3).
Hyp.2: The intervention groups significantly differ in their effects on correct hand hygiene behaviour at key times (T1-T3).
Hyp.3. The intervention groups show a significant increase in (not correct) hand hygiene behaviour at key times (T3).
Hyp.4. The groups attending a motivation module show a significant increase in a) intention, b) self-efficacy, c) outcome expectancies and d) attitude from T1 to the post measures.
Hyp.5. The groups attending a habit module show a significant increase in a) habit strength, b) action control, and c) planning from T1 to the post measures.
Hyp.6. The groups attending a social norms module show a significant increase in a) injunctive norms and b) descriptive norms from T1 to the post measures.
Evaluation:
Hyp. 7. The intervention group show a greater increase in correct hand hygiene behaviour at key times at the post measure (H7a) and at 6-month follow-up (H7b) compared to the control group.
Hyp. 8 The intervention group show a significant increase in the targeted behavioural determinants that are included compared to the control group at the post-intervention measure (H8a) and at 6-month follow-up (H8b). [the exact behavioural determinants depend on the results of the optimisation phase].
Statistics:
In the optimisation phase, 387 subjects are to be randomized. This sample size was determined with an a priori power analysis with g*power (Faul et al., 2009). The aim is that a statistical analysis using repeated-measures ANOVA with a within-between-interaction with a power of 0.80 and α = 0.05, a small effect of f =0.1 should be detectable. Accounting for 20% attrition, this leads to N = 465 for the enrolment in the parallel control trial.
In the evaluation phase, 204 new subjects are to be randomized. The aim is that that a statistical analysis using an independent samples t-test adopting an error probability and statistical power of α = 0.05 and β = 0.80, at least a small intermediate intervention effect of Cohen's d = 0.35 should be detectable (Faul et al., 2007). Accounting for 20% attrition, this leads to N = 245 for the enrolment in the RCT.
There is no statistical criterion of termination of trial. If more participate are included in the study than 387 people in the optimisation phase and 204 people in the evaluation phase, the results can be examined in more detail and more complex contexts in terms of differential indication can be examined thereby helping to improve the intervention.
Planned Analyses:
The analysed sample includes all randomized participants. The analyses are carried out on the basis of the intention-to-treat approach.
In the optimisation phase, the primary analyses will be conducted (T1-T3) to test the hypotheses using R and SPSS after 387 participants have completed the study.
To address the primary research question, the main effect of a univariate analysis of variance with repeated measures will be analysed. After, post-hoc comparison analyses with independent t-test will be conducted between all groups. Last, multiple linear regression analyses will be conducted to test the effect of the targeted behavioural determinants on the outcome.
In the evaluation phase, the primary analyses will be conducted (pre-test, post-test, follow-up) to test the hypotheses using R and SPSS after 204 participants have completed the study. Secondary follow-up analyses will be conducted six months later. Multiple linear regression analyses will be conducted to test the effect of the targeted behavioural determinants on the outcome and to test mediation hypotheses.
The qualitative data in the optimisation phase are analysed by using thematic analysis (Braun \& Clarke, 2006).
No interim analyses or safety analyses are planned. Deviations from the planned analyses will be reported in the final report.
Handling of missing data and drop-outs:
The main analysis will be performed according to the intention-to-treat (ITT) principle. The ITT analysis includes every subject who is randomized according to randomized study group. It ignores noncompliance, protocol deviations as not adhering to the intervention modules, and anything that happens after randomization. Participants who withdrew consent are excluded from ITT analysis. ITT analysis avoids overoptimistic estimates of the efficacy of an intervention resulting from the removal of non-compliers by accepting that noncompliance and protocol deviations are likely to occur in practice.
To analyse the investigators' hypotheses and research questions, the investigators follow-the ITT analysis strategy. This includes: 1) Attempt to follow up all randomized individuals, even if they withdraw from allocated group. 2) Perform a main analysis that is valid under a plausible assumption about the missing data and that uses all observed data 3) Perform sensitivity analyses to explore the impact of departures from the assumption made in the main analysis 4) Account for all randomized individuals, at least in the sensitivity analyses.
- Conditions
- Hand Hygiene
- Being tested
- Motivation, Habit, Social
- Keywords
- Behavioral intervention, Hand hygiene behavior, MOST, Health behavior change
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MotivationBehavioural
The key constructs targeted by the motivational module are attitudes towards the target behavior, risk perception, outcome expectancies and self-efficacy. The intervention includes the following techniques: information about health consequences, salience of consequences, goal setting (behavior), problem solving, verbal persuasion about capabilities, focus on past success (Michie et al., 2013)
HabitBehavioural
The goal of the habit module is to guide participants to perform correct hand hygiene at self-selected key times repeatedly. The aim is that the behavior will be translated into a habit. The intervention includes the following techniques: Information about antecedents, self-monitoring of behavior, action planning, prompts/cues, habit formation, behavioral practice/ rehearsal, prompts/cues (physical cue) (Michie et al., 2013).
SocialBehavioural
The key constructs targeted by the social module are perceived norms including descriptive norms and injunctive norm. The intervention includes the following techniques: Monitoring of behavior by others, social incentive, social comparison, social reward, restructuring the physical environment, information about others approval, credible source, information about health consequences, feedback on behavior (Michie et al., 2013).
| Study group | Role | What they receive |
|---|---|---|
| Habit - Motivation group | Experimental | First: 2 weeks habit intervention; Second: 2 weeks motivation intervention Receives: Behavioral: Motivation; Behavioral: Habit |
| Habit - Social group | Experimental | First: 2 weeks habit intervention; Second: 2 weeks social intervention Receives: Behavioral: Habit; Behavioral: Social |
| Habit - Habit group | Experimental | 4 weeks habit intervention Receives: Behavioral: Habit |
| Motivation - Habit group | Experimental | First: 2 weeks motivation intervention; Second: 2 weeks habit intervention Receives: Behavioral: Motivation; Behavioral: Habit |
| Motivation - Social group | Experimental | First: 2 weeks motivation intervention; Second: 2 weeks social intervention Receives: Behavioral: Motivation; Behavioral: Social |
| Motivation - Motivation group | Experimental | 4 weeks motivation intervention Receives: Behavioral: Motivation |
| Social - Habit group | Experimental | First: 2 weeks social intervention; Second: 2 weeks habit intervention Receives: Behavioral: Habit; Behavioral: Social |
| Social - Motivation group | Experimental | First: 2 weeks social intervention; Second: 2 weeks motivation intervention Receives: Behavioral: Motivation; Behavioral: Social |
| Social - Social group | Experimental | 4 weeks social intervention Receives: Behavioral: Social |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average frequency of correct hand hygiene behaviour at key times
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).
Measured: Day 16 (after module 1)
Average frequency of correct hand hygiene behaviour at key times
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).
Measured: Day 33 (after module 2)
Secondary outcomes (18)
Frequency of hand hygiene behaviour at key times, but not correctly
How many times they wash or disinfect their hands, but not correctly? The responses 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 not-correctly performed hand hygiene at key times that day (scale ranging from 0 to 4).
Measured: Day 16 (after module 1) and day 33 (after module 2)
Self-reported behavioural intention
One item: "To what extent do you intend to correctly perform your hand hygiene behavior at key times?" The response options ranged from 1 "not at all" to 6 "very strongly." Higher scores indicate stronger intention.
Measured: Day 17 (main survey T2) and day 34 (main survey T3)
Mean score of self-reported fife risk perception items
Fife items such as "To what extent do you think that the probability is high that I will have serious health problems, if I do not perform correct hand hygiene behavior at key times?" The response options ranged from 1 "not at all" to 6 "very strongly." Higher scores indicate higher risk perception.
Measured: Day 17 (main survey T2) and day 34 (main survey T3)
Mean score of eight self-reported outcome-expectancies items
Eight items such as "If I do not perform correct hand hygiene behavior at key times, then I stay rather healthy" The response options ranged from 1 "not at all" to 6 "very strongly." Higher scores indicate higher outcome-expectancies.
Measured: Day 17 (main survey T2) and day 34 (main survey T3)
Mean score of four self-reported coping planning items
Four items such as: "I have made a detailed plan about how I can perform correct hand hygiene behavior at key times, when soap and water are not available' The response options ranged from 1 "not at all" to 6 "very strongly." Higher scores indicate higher coping planning.
Measured: Day 17 (main survey T2) and day 34 (main survey T3)
Mean score of three self-reported action planning items
Three items such as: "I have made a detailed plan about when I am going to wash and disinfect may hands." The response options ranged from 1 "not at all" to 6 "very strongly." Higher scores indicate higher action planning.
Measured: Day 17 (main survey T2) and day 34 (main survey T3)
Habit strength assessed with the self-report habit index (SRHI)
Self-Report Habit Index (SRHI) with four times such as: "Correct hand hygiene behavior at key times is something that I do automatically." The response options ranged from 1 "strongly disagree" to 6 "strongly agree"
Measured: Day 17 (main survey T2) and day 34 (main survey T3)
Mean score of three self-reported injunctive norm items
Three items such as "To what extent do you think that most people who are important to me approve correct hand hygiene behavior at key times? The response options ranged from 1 "not at all" to 6 "very strongly." Higher scores indicate higher injunctive norms.
Measured: Day 17 (main survey T2) and day 34 (main survey T3)
Mean score of two self-reported descriptive norm items
Two times such as "To what extent do you think that most people who are important to me perform correct hand hygiene behavior at key times? The response options ranged from 1 "not at all" to 6 "very strongly." Higher scores indicate higher descriptive norms.
Measured: Day 17 (main survey T2) and day 34 (main survey T3)
Mean score of six self-reported attitude items
Six items such as "Correct hand hygiene behavior at key times is…" response range from pleasant to unpleasant. Higher scores indicate higher attitude.
Measured: Day 17 (main survey T2) and day 34 (main survey T3)
Mean score of three self-reported action control items
Three items such as "During the last two weeks I have constantly monitored myself whether I washed or disinfected my hands according to my plans" The response options ranged from 1 "not at all" to 6 "very strongly." With the additional item option "During the last two weeks, I did not intend to perform correct hand hygiene behavior at key times". Higher scores indicate higher action control.
Measured: Day 17 (main survey T2) and day 34 (main survey T3)
User engagement assessed with the DBCI Engagement Scale
Eight items such as "How strongly did you experience interest?" Response ranged from "not at all" to "moderately" to "extremely"
Measured: Day 17 (main survey T2) and day 34 (main survey T3)
Intervention usability using the System Usability Scale (SUS)
Ten items such as "I think that I would like to use this product frequently". Response range from 1 "strongly disagree" to 6 "strongly agree"
Measured: Day 17 (main survey T2) and day 34 (main survey T3)
Satisfaction using the ZUF-8 (Original Englische Version CSQ-8)
Eight items such as "Would you recommend this app to a friend" responses are 1 definitely not / 2 not really / 3 rather yes / 4 definitely yes
Measured: Day 17 (main survey T2) and day 34 (main survey T3)
Mean score of intervention fidelity items
Items generated to evaluate the interventions. Fifteen items such as "The description in the soapp app was clear to me" or "The tasks with the pro and contra list was fun" The response options ranged from 1 "not at all" to 6 "very strongly."
Measured: Day 17 (main survey T2) and day 34 (main survey T3)
Self-reported flu-like infection symptoms
In the last two weeks, did you have flu-like infection symptoms?
Measured: Day 17 (main survey T2) and day 34 (main survey T3)
Self-reported statement of the occurrences of Covid-19.
In the last two weeks, did you have a positive corona test?
Measured: Day 17 (main survey T2) and day 34 (main survey T3)
Mean score of eight self-reported self-efficacy items
Eight items such as "How confident are you that you correctly wash/disinfect your hands at key times, when you are on the way" The response options ranged from 1 "not at all" to 6 "very strongly." Higher scores indicate higher self-efficacy.
Measured: Day 17 (main survey T2) and day 34 (main survey T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start26 Mar 2021
- Primary completion31 Dec 2022
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Hand HygieneStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this study, the MOST methodology (multiphase optimization strategy; Collins et al., 2007) 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 with nine intervention groups that investigates three interventions modules in different order. After this optimisation phase, the final intervention will be tested against an active control group (basic app content) in a randomized controlled trial, which is called the evaluation phase.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 425 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Ursula Wirz Stiftung
- Responsible party
- Sponsor
- Investigators
- Dario Baretta, Dr., Study chair, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830761
- Sponsor's protocol ID
- 2021-00164
- Status last verified
- May 2023
- First submitted
- 25 Mar 2021
- Last updated
- 8 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Michie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, Eccles MP, Cane J, Wood CE. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013 Aug;46(1):81-95. doi: 10.1007/s12160-013-9486-6.
PubMed 23512568Collins LM, Murphy SA, Strecher V. The multiphase optimization strategy (MOST) and the sequential multiple assignment randomized trial (SMART): new methods for more potent eHealth interventions. Am J Prev Med. 2007 May;32(5 Suppl):S112-8. doi: 10.1016/j.amepre.2007.01.022.
PubMed 17466815Reyes Fernandez B, Knoll N, Hamilton K, Schwarzer R. Social-cognitive antecedents of hand washing: Action control bridges the planning-behaviour gap. Psychol Health. 2016 Aug;31(8):993-1004. doi: 10.1080/08870446.2016.1174236. Epub 2016 Apr 26.
PubMed 27049339Allan JL, Sniehotta FF, Johnston M. The best laid plans: planning skill determines the effectiveness of action plans and implementation intentions. Ann Behav Med. 2013 Aug;46(1):114-20. doi: 10.1007/s12160-013-9483-9.
PubMed 23456214Bierbauer W, Inauen J, Schaefer S, Kleemeyer MM, Luscher J, Konig C, Tobias R, Kliegel M, Ihle A, Zimmerli L, Holzer BM, Siebenhuener K, Battegay E, Schmied C, Scholz U. Health Behavior Change in Older Adults: Testing the Health Action Process Approach at the Inter- and Intraindividual Level. Appl Psychol Health Well Being. 2017 Nov;9(3):324-348. doi: 10.1111/aphw.12094. Epub 2017 Oct 12.
PubMed 29024515Orbell S, Verplanken B. The automatic component of habit in health behavior: habit as cue-contingent automaticity. Health Psychol. 2010 Jul;29(4):374-83. doi: 10.1037/a0019596.
PubMed 20658824Ajzen I. The theory of planned behaviour: reactions and reflections. Psychol Health. 2011 Sep;26(9):1113-27. doi: 10.1080/08870446.2011.613995.
PubMed 21929476Sniehotta FF, Scholz U, Schwarzer R. Action plans and coping plans for physical exercise: A longitudinal intervention study in cardiac rehabilitation. Br J Health Psychol. 2006 Feb;11(Pt 1):23-37. doi: 10.1348/135910705X43804.
PubMed 16480553Perski O, Blandford A, Garnett C, Crane D, West R, Michie S. A self-report measure of engagement with digital behavior change interventions (DBCIs): development and psychometric evaluation of the "DBCI Engagement Scale". Transl Behav Med. 2020 Feb 3;10(1):267-277. doi: 10.1093/tbm/ibz039.
PubMed 30927357Schmidt J, Lamprecht F, Wittmann WW. [Satisfaction with inpatient management. Development of a questionnaire and initial validity studies]. Psychother Psychosom Med Psychol. 1989 Jul;39(7):248-55. German.
PubMed 2762479Schwarzer R, Schuz B, Ziegelmann JP, Lippke S, Luszczynska A, Scholz U. Adoption and maintenance of four health behaviors: theory-guided longitudinal studies on dental flossing, seat belt use, dietary behavior, and physical activity. Ann Behav Med. 2007 Apr;33(2):156-66. doi: 10.1007/BF02879897.
PubMed 17447868Braun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative research in psychology, 3(2), 77-101.
Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PubMed 17695343Baretta D, Ruttimann CL, Amrein MA, Inauen J. Promoting Hand Hygiene During the COVID-19 Pandemic: Randomized Controlled Trial of the Optimized Soapp+ App. JMIR Mhealth Uhealth. 2025 Apr 24;13:e57191. doi: 10.2196/57191.
PubMed 40273441Baretta D, Amrein MA, Bader C, Ruschetti GG, Ruttimann C, Del Rio Carral M, Fabian C, Inauen J. Promoting Hand Hygiene During the COVID-19 Pandemic: Parallel Randomized Trial for the Optimization of the Soapp App. JMIR Mhealth Uhealth. 2023 Feb 3;11:e43241. doi: 10.2196/43241.
PubMed 36599056
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behaviour Change in Context to Contain the Spread of COVID-19
- ClinicalTrials.gov ID
- NCT04830761
- Acronym / sponsor ID
- 2021-00164
- Conditions
- Hand Hygiene
- Keywords
- Behavioral intervention, Hand hygiene behavior, MOST, Health behavior change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- Ursula Wirz Stiftung
- Study start
- 26 Mar 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 5 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
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.
In the evaluation phase, the optimised intervention from the optimisation phase will be tested in an RCT. To this end, participants will be randomly assigned to one of two conditions: final intervention vs. active control group. The active control group has access to the app, receives the basic module to test the effect of the final intervention, will answer the three questionnaires (pre-test, post-test, follow-up), and the short questionnaires (diary days).
Recruitment and informed consent procedure:
The sample will be recruited via Facebook and Instagram. Those who click on the link of the campaign will lead to a landing page with the relevant study information. Here, participants read the study info and enter their e-mail address. When they click on "send", an info box explains that an email has been sent including the link to the actual study.
In the mail, the participants can access via link to an eligibility and consent survey with detailed information about the nature of the study (=optimization and evaluation phase), its purpose, the procedures involved, the expected duration, the potential risks and benefits, any discomfort it may entail and finally an e-consent form to give consent to the study electronically. If people meet all inclusion criteria, the participants can directly sign with the mouse (on computer) or finger (on mobile device) the consent form.
After the participants agree to participate in the study, they receive a registration code via e-Mail to participate in the study as well as a signed copy of the consent form (at the latest of one week after giving consent electronically).
In the mail, the participants are guided to download the app "soapp" from their app store with the registration code. After downloading the app, they have to register and tip in the registration code. After that, they start with the first questionnaire T1 (optimization phase) or pre-test (evaluation phase).
Study procedure:
The duration of the study is 5 weeks (optimisation phase) plus a 6-month follow-up in the evaluation phase. Each participant receives two different intervention modules which each last 2 weeks.
After downloading the study app, the participants receive the first baseline questionnaire (T1 or pre-test).
Optimization phase: The day after T1, people attend a diary day. The diary day includes five 1-minute-questionnaires during one day. People will be informed that the intervention starts on the subsequent day after the diary day. The intervention will take four weeks and includes two modules. During the first module, people will attend another diary day at the end of each week (2 in total during one module). On the subsequent day of the last dairy day of the first module, people will receive the second questionnaire (T2). After T2, the second intervention module follows in the same structure: The participants follow the instructions of the intervention and their hand hygiene behaviour is surveyed on the last day of each week using the short questionnaire within the diary day. A day after the participants completed the last diary day and with that the second module, they receive the last questionnaire (T3). Additionally, to the normal questionnaire, the participants can indicate at T3, whether they are willing to take part in a qualitative survey. Here, people will be interviewed via telephone by a study member. This interview will take around 30 minutes for the participants, where they will be asked questions about the usability of the app and their experience with the intervention modules. This information will be used to improve the study app before starting with the evaluation phase. By the end of the study, the participants will have completed three questionnaires (T1-T3) and five short-questionnaires.
Evaluation phase: The day after the pre-test questionnaire, people attend a diary day to assess their previous hand hygiene behaviour. People will be informed that the intervention starts on the subsequent day after the diary day. The intervention will run for four weeks. During these four weeks, people will attend another diary day at the end of each week (4 in total during the total intervention). A day after the last diary day of the intervention, participants are asked to fill in the second questionnaire (post-test). In the evaluation phase, the participants will receive a six-month follow-up. They will first attend a diary day after 6 months after the intervention started and will then receive the follow-up questionnaire the subsequent day. By the end of the study, the participants will have completed three questionnaires (pre-test, post-test, follow-up) and six short-questionnaires.
Hypotheses:
Optimisation:
Hyp.1: The intervention groups show a significant increase in correct hand hygiene behaviour at key times (T3).
Hyp.2: The intervention groups significantly differ in their effects on correct hand hygiene behaviour at key times (T1-T3).
Hyp.3. The intervention groups show a significant increase in (not correct) hand hygiene behaviour at key times (T3).
Hyp.4. The groups attending a motivation module show a significant increase in a) intention, b) self-efficacy, c) outcome expectancies and d) attitude from T1 to the post measures.
Hyp.5. The groups attending a habit module show a significant increase in a) habit strength, b) action control, and c) planning from T1 to the post measures.
Hyp.6. The groups attending a social norms module show a significant increase in a) injunctive norms and b) descriptive norms from T1 to the post measures.
Evaluation:
Hyp. 7. The intervention group show a greater increase in correct hand hygiene behaviour at key times at the post measure (H7a) and at 6-month follow-up (H7b) compared to the control group.
Hyp. 8 The intervention group show a significant increase in the targeted behavioural determinants that are included compared to the control group at the post-intervention measure (H8a) and at 6-month follow-up (H8b). [the exact behavioural determinants depend on the results of the optimisation phase].
Statistics:
In the optimisation phase, 387 subjects are to be randomized. This sample size was determined with an a priori power analysis with g*power (Faul et al., 2009). The aim is that a statistical analysis using repeated-measures ANOVA with a within-between-interaction with a power of 0.80 and α = 0.05, a small effect of f =0.1 should be detectable. Accounting for 20% attrition, this leads to N = 465 for the enrolment in the parallel control trial.
In the evaluation phase, 204 new subjects are to be randomized. The aim is that that a statistical analysis using an independent samples t-test adopting an error probability and statistical power of α = 0.05 and β = 0.80, at least a small intermediate intervention effect of Cohen's d = 0.35 should be detectable (Faul et al., 2007). Accounting for 20% attrition, this leads to N = 245 for the enrolment in the RCT.
There is no statistical criterion of termination of trial. If more participate are included in the study than 387 people in the optimisation phase and 204 people in the evaluation phase, the results can be examined in more detail and more complex contexts in terms of differential indication can be examined thereby helping to improve the intervention.
Planned Analyses:
The analysed sample includes all randomized participants. The analyses are carried out on the basis of the intention-to-treat approach.
In the optimisation phase, the primary analyses will be conducted (T1-T3) to test the hypotheses using R and SPSS after 387 participants have completed the study.
To address the primary research question, the main effect of a univariate analysis of variance with repeated measures will be analysed. After, post-hoc comparison analyses with independent t-test will be conducted between all groups. Last, multiple linear regression analyses will be conducted to test the effect of the targeted behavioural determinants on the outcome.
In the evaluation phase, the primary analyses will be conducted (pre-test, post-test, follow-up) to test the hypotheses using R and SPSS after 204 participants have completed the study. Secondary follow-up analyses will be conducted six months later. Multiple linear regression analyses will be conducted to test the effect of the targeted behavioural determinants on the outcome and to test mediation hypotheses.
The qualitative data in the optimisation phase are analysed by using thematic analysis (Braun \& Clarke, 2006).
No interim analyses or safety analyses are planned. Deviations from the planned analyses will be reported in the final report.
Handling of missing data and drop-outs:
The main analysis will be performed according to the intention-to-treat (ITT) principle. The ITT analysis includes every subject who is randomized according to randomized study group. It ignores noncompliance, protocol deviations as not adhering to the intervention modules, and anything that happens after randomization. Participants who withdrew consent are excluded from ITT analysis. ITT analysis avoids overoptimistic estimates of the efficacy of an intervention resulting from the removal of non-compliers by accepting that noncompliance and protocol deviations are likely to occur in practice.
To analyse the investigators' hypotheses and research questions, the investigators follow-the ITT analysis strategy. This includes: 1) Attempt to follow up all randomized individuals, even if they withdraw from allocated group. 2) Perform a main analysis that is valid under a plausible assumption about the missing data and that uses all observed data 3) Perform sensitivity analyses to explore the impact of departures from the assumption made in the main analysis 4) Account for all randomized individuals, at least in the sensitivity analyses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 9
- Model description
- In this study, the MOST methodology (multiphase optimization strategy; Collins et al., 2007) 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 with nine intervention groups that investigates three interventions modules in different order. After this optimisation phase, the final intervention will be tested against an active control group (basic app content) in a randomized controlled trial, which is called the evaluation phase.
| Arm | Type | Receives |
|---|---|---|
| Habit - Motivation group | Experimental | Behavioral: Motivation, Behavioral: HabitFirst: 2 weeks habit intervention; Second: 2 weeks motivation intervention |
| Habit - Social group | Experimental | Behavioral: Habit, Behavioral: SocialFirst: 2 weeks habit intervention; Second: 2 weeks social intervention |
| Habit - Habit group | Experimental | Behavioral: Habit4 weeks habit intervention |
| Motivation - Habit group | Experimental | Behavioral: Motivation, Behavioral: HabitFirst: 2 weeks motivation intervention; Second: 2 weeks habit intervention |
| Motivation - Social group | Experimental | Behavioral: Motivation, Behavioral: SocialFirst: 2 weeks motivation intervention; Second: 2 weeks social intervention |
| Motivation - Motivation group | Experimental | Behavioral: Motivation4 weeks motivation intervention |
| Social - Habit group | Experimental | Behavioral: Habit, Behavioral: SocialFirst: 2 weeks social intervention; Second: 2 weeks habit intervention |
| Social - Motivation group | Experimental | Behavioral: Motivation, Behavioral: SocialFirst: 2 weeks social intervention; Second: 2 weeks motivation intervention |
| Social - Social group | Experimental | Behavioral: Social4 weeks social intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MotivationThe key constructs targeted by the motivational module are attitudes towards the target behavior, risk perception, outcome expectancies and self-efficacy. The intervention includes the following techniques: information about health consequences, salience of consequences, goal setting (behavior), problem solving, verbal persuasion about capabilities, focus on past success (Michie et al., 2013) | Behavioural | Habit - Motivation group, Motivation - Habit group, Motivation - Motivation group, Motivation - Social group, Social - Motivation group |
| HabitThe goal of the habit module is to guide participants to perform correct hand hygiene at self-selected key times repeatedly. The aim is that the behavior will be translated into a habit. The intervention includes the following techniques: Information about antecedents, self-monitoring of behavior, action planning, prompts/cues, habit formation, behavioral practice/ rehearsal, prompts/cues (physical cue) (Michie et al., 2013). | Behavioural | Habit - Habit group, Habit - Motivation group, Habit - Social group, Motivation - Habit group, Social - Habit group |
| SocialThe key constructs targeted by the social module are perceived norms including descriptive norms and injunctive norm. The intervention includes the following techniques: Monitoring of behavior by others, social incentive, social comparison, social reward, restructuring the physical environment, information about others approval, credible source, information about health consequences, feedback on behavior (Michie et al., 2013). | Behavioural | Habit - Social group, Motivation - Social group, Social - Habit group, Social - Motivation group, Social - Social group |
Primary outcome
Average frequency of correct hand hygiene behaviour at key times
Time frame: Day 16 (after module 1)
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).
Average frequency of correct hand hygiene behaviour at key times
Time frame: 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).
18 secondary outcomes
Frequency of hand hygiene behaviour at key times, but not correctly
Time frame: Day 16 (after module 1) and day 33 (after module 2)
Self-reported behavioural intention
Time frame: Day 17 (main survey T2) and day 34 (main survey T3)
Mean score of self-reported fife risk perception items
Time frame: Day 17 (main survey T2) and day 34 (main survey T3)
Mean score of eight self-reported outcome-expectancies items
Time frame: Day 17 (main survey T2) and day 34 (main survey T3)
Mean score of four self-reported coping planning items
Time frame: Day 17 (main survey T2) and day 34 (main survey T3)
Mean score of three self-reported action planning items
Time frame: Day 17 (main survey T2) and day 34 (main survey T3)
Habit strength assessed with the self-report habit index (SRHI)
Time frame: Day 17 (main survey T2) and day 34 (main survey T3)
Mean score of three self-reported injunctive norm items
Time frame: Day 17 (main survey T2) and day 34 (main survey T3)
Mean score of two self-reported descriptive norm items
Time frame: Day 17 (main survey T2) and day 34 (main survey T3)
Mean score of six self-reported attitude items
Time frame: Day 17 (main survey T2) and day 34 (main survey T3)
Mean score of three self-reported action control items
Time frame: Day 17 (main survey T2) and day 34 (main survey T3)
User engagement assessed with the DBCI Engagement Scale
Time frame: Day 17 (main survey T2) and day 34 (main survey T3)
Intervention usability using the System Usability Scale (SUS)
Time frame: Day 17 (main survey T2) and day 34 (main survey T3)
Satisfaction using the ZUF-8 (Original Englische Version CSQ-8)
Time frame: Day 17 (main survey T2) and day 34 (main survey T3)
Mean score of intervention fidelity items
Time frame: Day 17 (main survey T2) and day 34 (main survey T3)
Self-reported flu-like infection symptoms
Time frame: Day 17 (main survey T2) and day 34 (main survey T3)
Self-reported statement of the occurrences of Covid-19.
Time frame: Day 17 (main survey T2) and day 34 (main survey T3)
Mean score of eight self-reported self-efficacy items
Time frame: Day 17 (main survey T2) and day 34 (main survey T3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2023.
- Background: PubMed 23512568Michie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, Eccles MP, Cane J, Wood CE. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013 Aug;46(1):81-95. doi: 10.1007/s12160-013-9486-6.
- Background: PubMed 17466815Collins LM, Murphy SA, Strecher V. The multiphase optimization strategy (MOST) and the sequential multiple assignment randomized trial (SMART): new methods for more potent eHealth interventions. Am J Prev Med. 2007 May;32(5 Suppl):S112-8. doi: 10.1016/j.amepre.2007.01.022.
- Background: PubMed 27049339Reyes Fernandez B, Knoll N, Hamilton K, Schwarzer R. Social-cognitive antecedents of hand washing: Action control bridges the planning-behaviour gap. Psychol Health. 2016 Aug;31(8):993-1004. doi: 10.1080/08870446.2016.1174236. Epub 2016 Apr 26.
- Background: PubMed 23456214Allan JL, Sniehotta FF, Johnston M. The best laid plans: planning skill determines the effectiveness of action plans and implementation intentions. Ann Behav Med. 2013 Aug;46(1):114-20. doi: 10.1007/s12160-013-9483-9.
- Background: PubMed 29024515Bierbauer W, Inauen J, Schaefer S, Kleemeyer MM, Luscher J, Konig C, Tobias R, Kliegel M, Ihle A, Zimmerli L, Holzer BM, Siebenhuener K, Battegay E, Schmied C, Scholz U. Health Behavior Change in Older Adults: Testing the Health Action Process Approach at the Inter- and Intraindividual Level. Appl Psychol Health Well Being. 2017 Nov;9(3):324-348. doi: 10.1111/aphw.12094. Epub 2017 Oct 12.
- Background: PubMed 20658824Orbell S, Verplanken B. The automatic component of habit in health behavior: habit as cue-contingent automaticity. Health Psychol. 2010 Jul;29(4):374-83. doi: 10.1037/a0019596.
- Background: PubMed 21929476Ajzen I. The theory of planned behaviour: reactions and reflections. Psychol Health. 2011 Sep;26(9):1113-27. doi: 10.1080/08870446.2011.613995.
- Background: PubMed 16480553Sniehotta FF, Scholz U, Schwarzer R. Action plans and coping plans for physical exercise: A longitudinal intervention study in cardiac rehabilitation. Br J Health Psychol. 2006 Feb;11(Pt 1):23-37. doi: 10.1348/135910705X43804.
- Background: PubMed 30927357Perski O, Blandford A, Garnett C, Crane D, West R, Michie S. A self-report measure of engagement with digital behavior change interventions (DBCIs): development and psychometric evaluation of the "DBCI Engagement Scale". Transl Behav Med. 2020 Feb 3;10(1):267-277. doi: 10.1093/tbm/ibz039.
- Background: PubMed 2762479Schmidt J, Lamprecht F, Wittmann WW. [Satisfaction with inpatient management. Development of a questionnaire and initial validity studies]. Psychother Psychosom Med Psychol. 1989 Jul;39(7):248-55. German.
- Background: PubMed 17447868Schwarzer R, Schuz B, Ziegelmann JP, Lippke S, Luszczynska A, Scholz U. Adoption and maintenance of four health behaviors: theory-guided longitudinal studies on dental flossing, seat belt use, dietary behavior, and physical activity. Ann Behav Med. 2007 Apr;33(2):156-66. doi: 10.1007/BF02879897.
- BackgroundBraun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative research in psychology, 3(2), 77-101.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dario Baretta, Dr. study chair
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivation, Habit and Social in people with Hand Hygiene, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average frequency of correct hand hygiene behaviour at key times (time frame: Day 16 (after module 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04830761, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2023.