Health LiteracyTHELEHEPATNCT04189380
Therapeutic Literacy Evaluation in Liver Transplanted Patients
A study testing HLQ (Health literacy questionnaire) and MoCA (Montreal Cognitive Assessment) in people with Health Literacy and Liver Transplantation, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Health literacy is a new concept in therapeutic patient education. Health Literacy has been defined as 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Literacy, Liver Transplantation
- What is being tested?
- HLQ (Health literacy questionnaire) and MoCA (Montreal Cognitive Assessment)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jan 2019to 18 Jun 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient > 18 years
- Liver transplanted patient > 1 year at the start of the study
- patient who are followed-up by an hepatologist in the center
- patient who understands and speaks French
Who cannot join
- patient not yet liver transplanted (on the waiting-list)
- patient who has not come back home yet
- patient who does not speak or understand French
- patient refusal to participate
- patient under supervision or guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Health literacy is a new concept in therapeutic patient education. Health Literacy has been defined as 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. Health literacy seems predictive of adherence 's patients to treatment or positive health behavior.
Liver transplanted patients need to modify their lifestyle and to perform new behaviors in order to improve their survival and their quality of life. Health literacy evaluation in these patients is necessary to know what they understand and to improve their intake.
Read more
The Aim of the study is to evaluate health literacy among liver transplanted patient and to perform liver transplanted patient profiles related to their own health literacy.
The second aim is to study the impact of health literacy on medication adherence and iatrogenic hospitalizations It is a monocentric non-randomized study. During the hepatologist consultation, the HLQ Health Literacy Questionnaire is performed to explore patient health understanding and perception. Then the pharmacist interviews the patient to explore motivations and brakes for their own healthcare; Furthermore, a cognitive and precarity evaluation is performed in order to analyze psychological or social factors which can influence health literacy.
Read the detailed description
Tests performed:
- Health Literacy Questionnaire: HLQ
- Montreal Cognitive Evaluation Assessment: MoCA
- EPICES: precarity test validated in French
- A qualitative interview
- Conditions
- Health Literacy, Liver Transplantation
- Being tested
- HLQ (Health literacy questionnaire), MoCA (Montreal Cognitive Assessment)
- Keywords
- Health literacy, liver transplanted patients, cognitive evaluation, social status
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLQ (Health literacy questionnaire)Other
each patient complete survey and self-assessment questionnaire before or after his medical consultation
MoCA (Montreal Cognitive Assessment)Other
each patient complete survey and self-assessment questionnaire before or after his medical consultation
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | liver transplanted patient Receives: Other: HLQ (Health literacy questionnaire); Other: MoCA (Montreal Cognitive Assessment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
health literacy questionnaire
a survey in 2 parts. Each part contains about twenty questions with Likert scale
Measured: day 1
Secondary outcomes (2)
MoCA questionnaire
evaluation of cognitive assessment and detection mild cognitive dysfunction at the consultation
Measured: day 1
EPICES questionnaire
auto-evaluation of social and economic status
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start23 Jan 2019
- Primary completion18 Jun 2019
- Study completion18 Jun 2019
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.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Talavera, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189380
- Sponsor's protocol ID
- RBHP 2018 TALAVERA
- Other IDs
- 2018-A01031-54
- Acronym
- THELEHEPAT
- Status last verified
- Dec 2020
- First submitted
- 28 Nov 2019
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Literacy Evaluation in Liver Transplanted Patients
- ClinicalTrials.gov ID
- NCT04189380
- Acronym / sponsor ID
- THELEHEPAT / RBHP 2018 TALAVERA
- Conditions
- Health Literacy, Liver Transplantation
- Keywords
- Health literacy, liver transplanted patients, cognitive evaluation, social status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 23 Jan 2019 (actual)
- Primary completion
- 18 Jun 2019 (actual)
- Study completion
- 18 Jun 2019 (actual)
- First posted
- 6 Dec 2019 (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.
Health literacy is a new concept in therapeutic patient education. Health Literacy has been defined as 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. Health literacy seems predictive of adherence 's patients to treatment or positive health behavior.
Liver transplanted patients need to modify their lifestyle and to perform new behaviors in order to improve their survival and their quality of life. Health literacy evaluation in these patients is necessary to know what they understand and to improve their intake.
The Aim of the study is to evaluate health literacy among liver transplanted patient and to perform liver transplanted patient profiles related to their own health literacy.
The second aim is to study the impact of health literacy on medication adherence and iatrogenic hospitalizations It is a monocentric non-randomized study. During the hepatologist consultation, the HLQ Health Literacy Questionnaire is performed to explore patient health understanding and perception. Then the pharmacist interviews the patient to explore motivations and brakes for their own healthcare; Furthermore, a cognitive and precarity evaluation is performed in order to analyze psychological or social factors which can influence health literacy.
Detailed description
Tests performed:
- Health Literacy Questionnaire: HLQ
- Montreal Cognitive Evaluation Assessment: MoCA
- EPICES: precarity test validated in French
- A qualitative interview
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Other: HLQ (Health literacy questionnaire), Other: MoCA (Montreal Cognitive Assessment)liver transplanted patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patient > 18 years
- Liver transplanted patient > 1 year at the start of the study
- patient who are followed-up by an hepatologist in the center
- patient who understands and speaks French
Key exclusion criteria (5 listed)
- patient not yet liver transplanted (on the waiting-list)
- patient who has not come back home yet
- patient who does not speak or understand French
- patient refusal to participate
- patient under supervision or guardianship
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 |
|---|---|---|
| HLQ (Health literacy questionnaire)each patient complete survey and self-assessment questionnaire before or after his medical consultation | Other | Cohort 1 |
| MoCA (Montreal Cognitive Assessment)each patient complete survey and self-assessment questionnaire before or after his medical consultation | Other | Cohort 1 |
Primary outcome
health literacy questionnaire
Time frame: day 1
a survey in 2 parts. Each part contains about twenty questions with Likert scale
2 secondary outcomes
MoCA questionnaire
Time frame: day 1
EPICES questionnaire
Time frame: day 1
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 14 Dec 2020.
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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.
Sarah Talavera principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HLQ (Health literacy questionnaire) and MoCA (Montreal Cognitive Assessment) in people with Health Literacy and Liver Transplantation, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 5 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 14 Dec 2020. 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 France. 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 questionnaire (time frame: day 1). 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 14 Dec 2020.