Health LiteracyNCT03561636
Health Literacy in the General Population in Belgium
An observational study of Health Literacy, run by University of Liege at 2 sites in Belgium.
Trial summary
The aims of the study are: To measure health literacy (HL) levels in a sample composed of members of a health mutual (Solidaris), and its potential associations with several determinants (health, health services consumption, health behaviours...) To identify potential groups at risk of a lower HL To identify the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Literacy
- How many people
- 2,535 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Jun 2017to 30 Jun 2018
- Phase
- Observational
- 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
Study population: Adults affiliated to Solidaris
Who may be able to join
- 18 years old or more
- Affiliated to Solidaris (health mutual), with a valid phone number
- Consent to participate
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
University of Liège
Liège, 4000
University Hospital of Liege
Liège, B-4000
About this study
Official title: Health Literacy in the General Population in Belgium: Associations and Determinants
The aims of the study are:
- To measure health literacy (HL) levels in a sample composed of members of a health mutual (Solidaris), and its potential associations with several determinants (health, health services consumption, health behaviours...)
- To identify potential groups at risk of a lower HL
- To identify the determinants of HL level
- Conditions
- Health Literacy
- Keywords
- Health literacy
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Literacy
The degree to which individuals can obtain, process and understand basic health information and services needed to make appropriate health decisions. It also includes the cognitive and social skills which determine the motivation and ability of individuals to gain access to, understand and use information in ways which promote and maintain good health. It is measured by the Health Literacy Questionnaire (HLQ) (Osborne et al., 2013), composed of 44 items (9 dimensions).
Measured: At the inclusion in the study
Secondary outcomes (9)
General health
Measured with the EQ-5D-5L (EuroQol Group, 1990), divided into 2 parts. The first part is composed of 5 items investigating 5 dimensions (mobility, autonomy, daily activities, pain, and anxiety and depression).
Measured: At the inclusion in the study
General health
Measured with the EQ-5D-5L (EuroQol Group, 1990), divided into 2 parts: the second part is composed of 1 Visual Analogue Scale (VAS, from 0 to 100), investigating the perceived health.
Measured: At the inclusion in the study
Chronic illnesses
Questions about the presence of chronic illness(es) are asked, along with their duration.
Measured: At the inclusion in the study
Body Mass Index
Calculated with the standard formula (weight/height²)
Measured: At the inclusion in the study
Feeling of stigma associated with the chronic illness
Measured with the Stigma Scale for Chronic Illnesses (Molina et al., 2013), which assesses enacted and internalised stigma. It is composed of 8 items. The responses for each item can be: 1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, and 5 = Always. The raw summed score range is 8-40, with a higher score indicating a higher perceived stigma. Raw scores are then transformed into T-scores (a result of rescaling raw scores into standardized scores with a mean of 50 and a standard deviation of 10).
Measured: At the inclusion in the study
Satisfaction about health services
Investigation of the participant's satisfaction about hospitals, dentists, specialised physician, general practitioners, home care and Solidaris, through 6 questions ranging from 1 (very unsatisfied) to 5 (very satisfied).
Measured: At the inclusion in the study
Consumption behaviors
Tobacco, alcohol, fruits and vegetables consumption are investigated through 5 questions: do you smoke ? / If yes, what do you smoke? / How often do you drink alcohol? / How often do you eat fruits? / How often do you eat vegetables?
Measured: At the inclusion in the study
Physical activity
Investigated through 2 questions: during the last 7 days, how many days did you practice intense physical activity? / during the last 7 days, how many days did you practice moderate physical activity? For each question, answers range from 0 to 7.
Measured: At the inclusion in the study
Use of the Internet for health purposes
Investigated through 1 question: "how often do you use the Internet to search information about your health?". Answers range from 1 (never) to 5 (always).
Measured: At the inclusion in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start1 Jun 2017
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health LiteracyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,535 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Collaborators
- Solidaris
- Responsible party
- Principal investigator, Isabelle Bragard, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561636
- Sponsor's protocol ID
- HL-Solidaris
- Status last verified
- Apr 2019
- First submitted
- 23 May 2018
- Last updated
- 24 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Literacy in the General Population in Belgium: Associations and Determinants
- ClinicalTrials.gov ID
- NCT03561636
- Acronym / sponsor ID
- HL-Solidaris
- Conditions
- Health Literacy
- Keywords
- Health literacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,535 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Collaborators
- Solidaris
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 19 Jun 2018 (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 aims of the study are:
- To measure health literacy (HL) levels in a sample composed of members of a health mutual (Solidaris), and its potential associations with several determinants (health, health services consumption, health behaviours...)
- To identify potential groups at risk of a lower HL
- To identify the determinants of HL level
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults affiliated to Solidaris
Key inclusion criteria (3 listed)
- 18 years old or more
- Affiliated to Solidaris (health mutual), with a valid phone number
- Consent to participate
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health Literacy
Time frame: At the inclusion in the study
The degree to which individuals can obtain, process and understand basic health information and services needed to make appropriate health decisions. It also includes the cognitive and social skills which determine the motivation and ability of individuals to gain access to, understand and use information in ways which promote and maintain good health. It is measured by the Health Literacy Questionnaire (HLQ) (Osborne et al., 2013), composed of 44 items (9 dimensions).
9 secondary outcomes
General health
Time frame: At the inclusion in the study
General health
Time frame: At the inclusion in the study
Chronic illnesses
Time frame: At the inclusion in the study
Body Mass Index
Time frame: At the inclusion in the study
Feeling of stigma associated with the chronic illness
Time frame: At the inclusion in the study
Satisfaction about health services
Time frame: At the inclusion in the study
Consumption behaviors
Time frame: At the inclusion in the study
Physical activity
Time frame: At the inclusion in the study
Use of the Internet for health purposes
Time frame: At the inclusion in the study
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 24 Apr 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Literacy, run by University of Liege at 2 sites in Belgium.
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 1 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 24 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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?
Health Literacy (time frame: At the inclusion in the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2019; AzTrials last refreshed its copy on 8 Nov 2026.