COVID-19NCT06076421
Equity Evaluation of Fact Boxes on Informed COVID-19 and Influenza Vaccination Decisions - Study Protocol
A study testing Fact box in people with COVID-19 and Influenza, run by Harding Center for Risk Literacy at 1 site in Germany.
Trial summary
The study aims to evaluate whether evidence-based fact boxes on COVID-19 and influenza vaccination contribute to the decision making of laypeople from different social backgrounds in different educational settings (e.g. medical practices, outreach work). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Fact box
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteGermany
- Study dates
- 17 Nov 2023to 30 May 2025
- 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
- Adults of legal age with current residence in Germany and who speak Arabic, German, Russian, Turkish
- People who are currently facing a decision about COVID-19 or influenza vaccination for themselves or a family member (e.g. caring relatives)
- Informed online consent
Who cannot join
- Language other than Arabic, German, Russian, Turkish
- People without a current vaccination decision
- No informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Harding Center for Risk Literacy, Faculty of Health Sciences Brandenburg, University of Potsdam
Potsdam, Brandenburg, 14482
About this study
Official title: Do Evidence-based Fact Boxes Improve Informed Decision-making About COVID-19 and Influenza Vaccination in More and Less Disadvantaged Groups Equally? - Study Protocol for a Multi-center Cluster RCT in Health and Social Care in Germany
The study aims to evaluate whether evidence-based fact boxes on COVID-19 and influenza vaccination contribute to the decision making of laypeople from different social backgrounds in different educational settings (e.g. medical practices, outreach work). Furthermore, the study will investigate whether evidence-based fact boxes can contribute to more equitable health care by improving shared decision-making.
Read the detailed description
Background
Evidence-based health information (EBHI) and decision aids (DA) are key components for improving health care by enabling more people to make informed decisions. However, despite their overall effectiveness, there is a risk that only certain groups of the population will benefit from them. Because although they are target group oriented, the factors that lead to inequality in terms of shared and informed decision-making have not yet been sufficiently taken into account in their development process. For example, there are many patient-oriented materials written at an advanced level, which makes the materials less accessible to people with reading difficulties, lower education, health literacy or socioeconomic status (SES).
Evidence-based fact boxes have been shown to support informed decision-making. However, few studies have analysed how the boxes support decision-making in different social groups. Further, it is unclear whether fact boxes promote informed and shared decision making equally when implemented by health educators (HE) in different settings. Hence, there is a risk that fact boxes will only help less disadvantaged people to make informed health decisions.
Objective
In a Multi-center, cluster-randomised, cross-sectional study, the effectiveness of evidence-based fact boxes (intervention) compared with usual health education/care (control) on outcomes relevant to the decision to vaccinate will be investigated in people from different backgrounds in Germany.
Fact boxes on COVID-19 and influenza vaccination have been adapted in several steps to meet the information needs and requirements of the population. This included feedback from various public health stakeholders on a COVID-19 fact box implemented in Germany in January 2021 by a national Public Health institute, the identification of information needs and requirements of the population in Germany based on secondary data analyses, and testing of COVID-19 fact boxes in pre-studies in population-wide surveys with N=1,942 to N=6,056 respondents in Germany. The data basis and individual studies have been described in detail elsewhere.
The Influenza vaccination fact box was updated in 2021 based on current evidence and is available on the Harding Center website for older people (65 years and older) and for people aged 16 to 65. During cognitive interviews, simplified COVID-19 and Influenza vaccination fact boxes were first piloted with German-speaking laypeople and adapted based on their feedback. Visualized COVID-19 fact boxes were also piloted with Arabic-, Turkish- and Russian-speaking laypeople from disadvantaged neighbourhoods in Berlin. A visualized flu fact box is currently being piloted by the University of Erfurt with German-speaking lay people.
Main research question
Do disadvantaged people benefit to the same extent as non-disadvantaged people in terms of informed and shared decision-making from receiving COVID-19 and influenza vaccination fact boxes as opposed to standard vaccination communication in medical practices and outreach work (field settings)?
Research questions (RQ) and main hypotheses (HYP)
RQ1 Is the use of fact boxes more effective than standard vaccine communication (control condition) in the field?
Primary HYP
- Compared to standard vaccine communication, fact boxes will lead to higher vaccination knowledge.
- Compared to standard vaccine communication, fact boxes will lead to more vaccination intentions that are in line with attitudes and vaccination knowledge (informed vaccination intentions; operationalised based on the multidimensional construct of informed choice by Marteau et al. 2001).
Secondary HYP
- Compared to standard vaccine communication, fact boxes will improve risk perception.
- Compared to standard vaccine communication, fact boxes will increase patient involvement in medical decision making.
- Compared to standard vaccine communication, fact boxes will decrease decisional conflict.
RQ2 Are fact boxes as effective for people with disadvantaging factors as for those without factors associated with disadvantages?
Primary HYP
Compared to standard vaccine communication, fact boxes will lead to a greater alignment of knowledge, informed vaccination intentions, and accuracy of risk perception between:
- People with low and high education through fact boxes compared to usual care.
- People with problematic or inadequate and excellent or sufficient level of health literacy through fact boxes compared to usual care.
- Non-native (Arabic, Turkish and Russian speaking participants, only with low German skills) and native German speakers (including non-native speakers with high German skills), because the investigators not only provide information in the native language, but also tested it with these target groups.
- People with low and high reading literacy in different languages, because fact boxes are a complexity-reduced format of health information and the investigators tried to address accessibility through pilot testing with different groups.
RQ3 Does the use of fact boxes in outreach work promote more shared and informed decision-making than in regular health care settings?
HYP
- Compared to standard vaccine communication fact boxes will more likely lead to more informed vaccination intentions and shared decisions in outreach work than in regular health care settings.
Explorative analyses
- The investigators will analyse the effect of fact boxes on knowledge, vaccination intentions, accuracy of risk perception between people with low and medium or high SSS through fact boxes compared to usual care.
- The investigators will analyse the effect of fact boxes on vaccination intentions, knowledge, risk perception, patient involvement, and decisional conflict among people with migration-related indicators (e.g., residential status, length of stay in Germany) compared to usual care, controlling for other factors describing the social situation (e.g., education, health literacy).
- Being tested
- Fact box
- Keywords
- health inequity, informed decision making, fact box, evidence-based health information, risk communication
- Medical subject headings
- COVID-19, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fact boxOther
Fact boxes provide a tabular or graphical overview of the benefits and harms of the COVID-19 or influenza vaccination through transparent risk communication. The fact boxes are available for two different age groups each: COVID-19 vaccination for people aged 18 to 59 and over 60, influenza vaccination for people aged 16 to 64 and over 65 in Arabic, German, Russian and Turkish.
| Study group | Role | What they receive |
|---|---|---|
| Evidence-based fact box on COVID-19 or influenza (intervention) | Experimental | Health educators (HE) will receive a flyer with a brief description of the study, a Quick Response-code (QR-code) and a link to an online survey, including either a fact box as tabular format or a visualization on the reverse side about COVID-19 or the flu vaccine to distribute to potential study participants. HE are free to decide if and how to use the fact boxes: whether during, before or after vaccination education, and who to target.
Participants who receive the flyer from their HE can decide on their own to participate in the study by using the QR-code or link on the flyer. Receives: Other: Fact box |
| Usual education/care | No intervention | Study participants whose HE will be randomised to the control will receive the same flyer but without a fact box on the reverse side. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge
10 items: five items on basic knowledge of the disease (e.g. how is Corona or the flu contracted and what are the possible baseline risks) and uncertainty (e.g. quality of evidence), each with 4 possible answers, of which only one is correct. A further five questions that can only be answered through the fact box, including one question on the benefits of vaccination gist and three questions on the benefits and harms of vaccination verbatim. Responses will be graded according to the best available evidence in July 2023.
Measured: at T1 (initial survey; study period: 3-6 month)
Informed vaccination intention
Based on vaccination knowledge, a person's attitudes and vaccination intentions.
Knowledge will be measured as described above. Attitudes will be measured using an 11-point Likert scale that captures the personal assessment of the balance between the potential benefits and risks of the respective vaccine. Vaccination intention will be measured by asking whether participants would have themselves or their relatives vaccinated at the next opportunity, on a scale of 1-5 (Definitely yes, probably yes, probably not, definitely not, I cannot yet say / am still undecided).
Measured: at T1 (initial survey; study period: 3-6 month)
Secondary outcomes (3)
Risk perception
Based on a frequency format (Please imagine 10 people like yourself: How many of them will be re-infected with COVID-19 after a previous coronavirus infection if they come into contact with a person who is infected with the coronavirus variant XBB.1.5?; How many will contract influenza in a year if the virus is widespread?): Correct responses (reflected the best available evidence, which can be found in the fact boxes together with the medical references.
Measured: at T1 (initial survey; study period: 3-6 month)
Decisional conflict
The 4-item SURE (Sure of myself; Understand information; Risk-benefit ratio; Encouragement) screening test will be used (if yes: 1, if no: 0; a score of < 4 is a positive result for decisional conflict)
Measured: at T1 (initial survey; study period: 3-6 month)
Patient involvement in decision making
Measured with the 9-item Shared Decision Making Questionnaire (SDM-Q-9). The instrument contains nine statements which are rated on a six-point Likert scale (from 0 'completely disagree' to 5 'completely agree').
Measured: at T1 (initial survey; study period: 3-6 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start17 Nov 2023
- Primary completion31 Mar 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomised cross-sectional controlled trial with a 2x2-design with the between-subjects factors: format (usual care plus evidence-based fact box vs. usual care), health educator (cluster unit medical practice vs. cluster unit outreach work settings) taking into account various factors of disadvantage (e.g., low education).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harding Center for Risk Literacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felix G. Rebitschek, Harding Center for Risk Literacy
- Investigators
- Christin Ellermann, MSc, Principal investigator, Harding Center for Risk LiteracyFelix G. Rebitschek, Dr., Principal investigator, Harding Center for Risk Literacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076421
- Sponsor's protocol ID
- 57/2022
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2023
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All relevant data will be provided in the manuscript and supporting information or made available in a public repository after completion of the study.
Publications
Adler NE, Epel ES, Castellazzo G, Ickovics JR. Relationship of subjective and objective social status with psychological and physiological functioning: preliminary data in healthy white women. Health Psychol. 2000 Nov;19(6):586-92. doi: 10.1037//0278-6133.19.6.586.
PubMed 11129362Pelikan JM, Link T, Strassmayr C, Waldherr K, Alfers T, Boggild H, Griebler R, Lopatina M, Miksova D, Nielsen MG, Peer S, Vrdelja M; HLS19 Consortium of the WHO Action Network M-POHL. Measuring Comprehensive, General Health Literacy in the General Adult Population: The Development and Validation of the HLS19-Q12 Instrument in Seventeen Countries. Int J Environ Res Public Health. 2022 Oct 29;19(21):14129. doi: 10.3390/ijerph192114129.
PubMed 36361025Kriston L, Scholl I, Holzel L, Simon D, Loh A, Harter M. The 9-item Shared Decision Making Questionnaire (SDM-Q-9). Development and psychometric properties in a primary care sample. Patient Educ Couns. 2010 Jul;80(1):94-9. doi: 10.1016/j.pec.2009.09.034. Epub 2009 Oct 30.
PubMed 19879711Legare F, Kearing S, Clay K, Gagnon S, D'Amours D, Rousseau M, O'Connor A. Are you SURE?: Assessing patient decisional conflict with a 4-item screening test. Can Fam Physician. 2010 Aug;56(8):e308-14.
PubMed 20705870Rebitschek FG, Ellermann C, Jenny MA, Siegel NA, Spinner C, Wagner GG. Fact boxes that inform individual decisions may contribute to a more positive evaluation of COVID-19 vaccinations at the population level. PLoS One. 2022 Sep 12;17(9):e0274186. doi: 10.1371/journal.pone.0274186. eCollection 2022.
PubMed 36095020Marteau TM, Dormandy E, Michie S. A measure of informed choice. Health Expect. 2001 Jun;4(2):99-108. doi: 10.1046/j.1369-6513.2001.00140.x.
PubMed 11359540Durand MA, Yen RW, O'Malley AJ, Schubbe D, Politi MC, Saunders CH, Dhage S, Rosenkranz K, Margenthaler J, Tosteson ANA, Crayton E, Jackson S, Bradley A, Walling L, Marx CM, Volk RJ, Sepucha K, Ozanne E, Percac-Lima S, Bergin E, Goodwin C, Miller C, Harris C, Barth RJ Jr, Aft R, Feldman S, Cyr AE, Angeles CV, Jiang S, Elwyn G. What matters most: Randomized controlled trial of breast cancer surgery conversation aids across socioeconomic strata. Cancer. 2021 Feb 1;127(3):422-436. doi: 10.1002/cncr.33248. Epub 2020 Nov 10.
PubMed 33170506Miller DP Jr, Spangler JG, Case LD, Goff DC Jr, Singh S, Pignone MP. Effectiveness of a web-based colorectal cancer screening patient decision aid: a randomized controlled trial in a mixed-literacy population. Am J Prev Med. 2011 Jun;40(6):608-15. doi: 10.1016/j.amepre.2011.02.019.
PubMed 21565651Ellermann C, Savaskan N, Rebitschek FG. Do summaries of evidence enable informed decision-making about COVID-19 and influenza vaccination equitably across more and less disadvantaged groups? Study protocol for a multi-centre cluster randomised controlled trial of 'fact boxes' in health and social care in Germany. BMJ Open. 2024 Nov 1;14(10):e083515. doi: 10.1136/bmjopen-2023-083515.
PubMed 39486820
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Evidence-based Fact Boxes Improve Informed Decision-making About COVID-19 and Influenza Vaccination in More and Less Disadvantaged Groups Equally? - Study Protocol for a Multi-center Cluster RCT in Health and Social Care in Germany
- ClinicalTrials.gov ID
- NCT06076421
- Acronym / sponsor ID
- 57/2022
- Keywords
- health inequity, informed decision making, fact box, evidence-based health information, risk communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Harding Center for Risk LiteracyUniversity, hospital or other
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 10 Oct 2023 (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.
The study aims to evaluate whether evidence-based fact boxes on COVID-19 and influenza vaccination contribute to the decision making of laypeople from different social backgrounds in different educational settings (e.g. medical practices, outreach work). Furthermore, the study will investigate whether evidence-based fact boxes can contribute to more equitable health care by improving shared decision-making.
Detailed description
Background
Evidence-based health information (EBHI) and decision aids (DA) are key components for improving health care by enabling more people to make informed decisions. However, despite their overall effectiveness, there is a risk that only certain groups of the population will benefit from them. Because although they are target group oriented, the factors that lead to inequality in terms of shared and informed decision-making have not yet been sufficiently taken into account in their development process. For example, there are many patient-oriented materials written at an advanced level, which makes the materials less accessible to people with reading difficulties, lower education, health literacy or socioeconomic status (SES).
Evidence-based fact boxes have been shown to support informed decision-making. However, few studies have analysed how the boxes support decision-making in different social groups. Further, it is unclear whether fact boxes promote informed and shared decision making equally when implemented by health educators (HE) in different settings. Hence, there is a risk that fact boxes will only help less disadvantaged people to make informed health decisions.
Objective
In a Multi-center, cluster-randomised, cross-sectional study, the effectiveness of evidence-based fact boxes (intervention) compared with usual health education/care (control) on outcomes relevant to the decision to vaccinate will be investigated in people from different backgrounds in Germany.
Fact boxes on COVID-19 and influenza vaccination have been adapted in several steps to meet the information needs and requirements of the population. This included feedback from various public health stakeholders on a COVID-19 fact box implemented in Germany in January 2021 by a national Public Health institute, the identification of information needs and requirements of the population in Germany based on secondary data analyses, and testing of COVID-19 fact boxes in pre-studies in population-wide surveys with N=1,942 to N=6,056 respondents in Germany. The data basis and individual studies have been described in detail elsewhere.
The Influenza vaccination fact box was updated in 2021 based on current evidence and is available on the Harding Center website for older people (65 years and older) and for people aged 16 to 65. During cognitive interviews, simplified COVID-19 and Influenza vaccination fact boxes were first piloted with German-speaking laypeople and adapted based on their feedback. Visualized COVID-19 fact boxes were also piloted with Arabic-, Turkish- and Russian-speaking laypeople from disadvantaged neighbourhoods in Berlin. A visualized flu fact box is currently being piloted by the University of Erfurt with German-speaking lay people.
Main research question
Do disadvantaged people benefit to the same extent as non-disadvantaged people in terms of informed and shared decision-making from receiving COVID-19 and influenza vaccination fact boxes as opposed to standard vaccination communication in medical practices and outreach work (field settings)?
Research questions (RQ) and main hypotheses (HYP)
RQ1 Is the use of fact boxes more effective than standard vaccine communication (control condition) in the field?
Primary HYP
- Compared to standard vaccine communication, fact boxes will lead to higher vaccination knowledge.
- Compared to standard vaccine communication, fact boxes will lead to more vaccination intentions that are in line with attitudes and vaccination knowledge (informed vaccination intentions; operationalised based on the multidimensional construct of informed choice by Marteau et al. 2001).
Secondary HYP
- Compared to standard vaccine communication, fact boxes will improve risk perception.
- Compared to standard vaccine communication, fact boxes will increase patient involvement in medical decision making.
- Compared to standard vaccine communication, fact boxes will decrease decisional conflict.
RQ2 Are fact boxes as effective for people with disadvantaging factors as for those without factors associated with disadvantages?
Primary HYP
Compared to standard vaccine communication, fact boxes will lead to a greater alignment of knowledge, informed vaccination intentions, and accuracy of risk perception between:
- People with low and high education through fact boxes compared to usual care.
- People with problematic or inadequate and excellent or sufficient level of health literacy through fact boxes compared to usual care.
- Non-native (Arabic, Turkish and Russian speaking participants, only with low German skills) and native German speakers (including non-native speakers with high German skills), because the investigators not only provide information in the native language, but also tested it with these target groups.
- People with low and high reading literacy in different languages, because fact boxes are a complexity-reduced format of health information and the investigators tried to address accessibility through pilot testing with different groups.
RQ3 Does the use of fact boxes in outreach work promote more shared and informed decision-making than in regular health care settings?
HYP
- Compared to standard vaccine communication fact boxes will more likely lead to more informed vaccination intentions and shared decisions in outreach work than in regular health care settings.
Explorative analyses
- The investigators will analyse the effect of fact boxes on knowledge, vaccination intentions, accuracy of risk perception between people with low and medium or high SSS through fact boxes compared to usual care.
- The investigators will analyse the effect of fact boxes on vaccination intentions, knowledge, risk perception, patient involvement, and decisional conflict among people with migration-related indicators (e.g., residential status, length of stay in Germany) compared to usual care, controlling for other factors describing the social situation (e.g., education, health literacy).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Cluster randomised cross-sectional controlled trial with a 2x2-design with the between-subjects factors: format (usual care plus evidence-based fact box vs. usual care), health educator (cluster unit medical practice vs. cluster unit outreach work settings) taking into account various factors of disadvantage (e.g., low education).
| Arm | Type | Receives |
|---|---|---|
| Evidence-based fact box on COVID-19 or influenza (intervention) | Experimental | Other: Fact boxHealth educators (HE) will receive a flyer with a brief description of the study, a Quick Response-code (QR-code) and a link to an online survey, including either a fact box as tabular format or a visualization on the reverse side about COVID-19 or the flu vaccine to distribute to potential study participants. HE are free to decide if and how to use the fact boxes: whether during, before or after vaccination education, and who to target. Participants who receive the flyer from their HE can decide on their own to participate in the study by using the QR-code or link on the flyer. |
| Usual education/care | No intervention | –Study participants whose HE will be randomised to the control will receive the same flyer but without a fact box on the reverse side. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults of legal age with current residence in Germany and who speak Arabic, German, Russian, Turkish
- People who are currently facing a decision about COVID-19 or influenza vaccination for themselves or a family member (e.g. caring relatives)
- Informed online consent
Key exclusion criteria (3 listed)
- Language other than Arabic, German, Russian, Turkish
- People without a current vaccination decision
- No informed consent
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 |
|---|---|---|
| Fact boxFact boxes provide a tabular or graphical overview of the benefits and harms of the COVID-19 or influenza vaccination through transparent risk communication. The fact boxes are available for two different age groups each: COVID-19 vaccination for people aged 18 to 59 and over 60, influenza vaccination for people aged 16 to 64 and over 65 in Arabic, German, Russian and Turkish. | Other | Evidence-based fact box on COVID-19 or influenza (intervention) |
Primary outcome
Knowledge
Time frame: at T1 (initial survey; study period: 3-6 month)
10 items: five items on basic knowledge of the disease (e.g. how is Corona or the flu contracted and what are the possible baseline risks) and uncertainty (e.g. quality of evidence), each with 4 possible answers, of which only one is correct. A further five questions that can only be answered through the fact box, including one question on the benefits of vaccination gist and three questions on the benefits and harms of vaccination verbatim. Responses will be graded according to the best available evidence in July 2023.
Informed vaccination intention
Time frame: at T1 (initial survey; study period: 3-6 month)
Based on vaccination knowledge, a person's attitudes and vaccination intentions. Knowledge will be measured as described above. Attitudes will be measured using an 11-point Likert scale that captures the personal assessment of the balance between the potential benefits and risks of the respective vaccine. Vaccination intention will be measured by asking whether participants would have themselves or their relatives vaccinated at the next opportunity, on a scale of 1-5 (Definitely yes, probably yes, probably not, definitely not, I cannot yet say / am still undecided).
3 secondary outcomes
Risk perception
Time frame: at T1 (initial survey; study period: 3-6 month)
Decisional conflict
Time frame: at T1 (initial survey; study period: 3-6 month)
Patient involvement in decision making
Time frame: at T1 (initial survey; study period: 3-6 month)
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 29 Sep 2026.
- Background: PubMed 11129362Adler NE, Epel ES, Castellazzo G, Ickovics JR. Relationship of subjective and objective social status with psychological and physiological functioning: preliminary data in healthy white women. Health Psychol. 2000 Nov;19(6):586-92. doi: 10.1037//0278-6133.19.6.586.
- Background: PubMed 36361025Pelikan JM, Link T, Strassmayr C, Waldherr K, Alfers T, Boggild H, Griebler R, Lopatina M, Miksova D, Nielsen MG, Peer S, Vrdelja M; HLS19 Consortium of the WHO Action Network M-POHL. Measuring Comprehensive, General Health Literacy in the General Adult Population: The Development and Validation of the HLS19-Q12 Instrument in Seventeen Countries. Int J Environ Res Public Health. 2022 Oct 29;19(21):14129. doi: 10.3390/ijerph192114129.
- Background: PubMed 19879711Kriston L, Scholl I, Holzel L, Simon D, Loh A, Harter M. The 9-item Shared Decision Making Questionnaire (SDM-Q-9). Development and psychometric properties in a primary care sample. Patient Educ Couns. 2010 Jul;80(1):94-9. doi: 10.1016/j.pec.2009.09.034. Epub 2009 Oct 30.
- Background: PubMed 20705870Legare F, Kearing S, Clay K, Gagnon S, D'Amours D, Rousseau M, O'Connor A. Are you SURE?: Assessing patient decisional conflict with a 4-item screening test. Can Fam Physician. 2010 Aug;56(8):e308-14.
- Background: PubMed 36095020Rebitschek FG, Ellermann C, Jenny MA, Siegel NA, Spinner C, Wagner GG. Fact boxes that inform individual decisions may contribute to a more positive evaluation of COVID-19 vaccinations at the population level. PLoS One. 2022 Sep 12;17(9):e0274186. doi: 10.1371/journal.pone.0274186. eCollection 2022.
- Background: PubMed 11359540Marteau TM, Dormandy E, Michie S. A measure of informed choice. Health Expect. 2001 Jun;4(2):99-108. doi: 10.1046/j.1369-6513.2001.00140.x.
- Background: PubMed 33170506Durand MA, Yen RW, O'Malley AJ, Schubbe D, Politi MC, Saunders CH, Dhage S, Rosenkranz K, Margenthaler J, Tosteson ANA, Crayton E, Jackson S, Bradley A, Walling L, Marx CM, Volk RJ, Sepucha K, Ozanne E, Percac-Lima S, Bergin E, Goodwin C, Miller C, Harris C, Barth RJ Jr, Aft R, Feldman S, Cyr AE, Angeles CV, Jiang S, Elwyn G. What matters most: Randomized controlled trial of breast cancer surgery conversation aids across socioeconomic strata. Cancer. 2021 Feb 1;127(3):422-436. doi: 10.1002/cncr.33248. Epub 2020 Nov 10.
- Background: PubMed 21565651Miller DP Jr, Spangler JG, Case LD, Goff DC Jr, Singh S, Pignone MP. Effectiveness of a web-based colorectal cancer screening patient decision aid: a randomized controlled trial in a mixed-literacy population. Am J Prev Med. 2011 Jun;40(6):608-15. doi: 10.1016/j.amepre.2011.02.019.
- Derived from this study: PubMed 39486820Ellermann C, Savaskan N, Rebitschek FG. Do summaries of evidence enable informed decision-making about COVID-19 and influenza vaccination equitably across more and less disadvantaged groups? Study protocol for a multi-centre cluster randomised controlled trial of 'fact boxes' in health and social care in Germany. BMJ Open. 2024 Nov 1;14(10):e083515. doi: 10.1136/bmjopen-2023-083515.
- Individual participant dataSharing planned: Yes. All relevant data will be provided in the manuscript and supporting information or made available in a public repository after completion of the study.
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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.
Christin Ellermann, MSc principal investigator
Harding Center for Risk Literacy
Felix G. Rebitschek, Dr. principal investigator
Harding Center for Risk Literacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fact box in people with COVID-19 and Influenza, run by Harding Center for Risk Literacy at 1 site in Germany.
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 3 inclusion and 3 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 29 Sep 2026. 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 Germany. 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?
Knowledge (time frame: at T1 (initial survey; study period: 3-6 month)). 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 NCT06076421, which also lists 9 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 29 Sep 2026.