Patient Education as TopicQUILAMNCT02865525
Development and Validation of a Self-administered QUestionnaire to Identify Levers of Adhesion Behavior to Patient's Medication in Order to Adapt the Educational Monitoring.
An observational study of Patient Education as Topic and Surveys and Questionnaires, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Medication non-adherence is an economic problem and a major public health challenge. Factors influencing medication adherence can be modelled according to five dimensions: disease, medication, patient and its close relatives, demographic and socioeconomic factors and health care system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Education as Topic, Surveys and Questionnaires, Medication Adherence
- How many people
- 282 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2013to Aug 2020
- How long will I take part?
- 12 Months
- 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
- No healthy volunteers
- Adult, Older adult
Study population: targeted pathologies: type 2 diabetes heart failure Chronic obstructive pulmonary disease
Who may be able to join
- Patient with at least one of the following pathologies: diabetes type II, COPD, heart failure
- person available for a follow-up of 1 year
- Affiliated to the social security or recipient of such a regime
Who cannot join
- Persons referred to in articles L1121-5 and L1121-8 in the french public health code
- Patient who do not speak french
Trial locations and contacts
1 site in 1 country.
About this study
Official title: QUILAM : Development and Validation of a Self-administered QUestionnaire to Identify Levers of Adhesion Behavior to Patient's Medication in Order to Adapt the Educational Monitoring
Medication non-adherence is an economic problem and a major public health challenge. Factors influencing medication adherence can be modelled according to five dimensions: disease, medication, patient and its close relatives, demographic and socioeconomic factors and health care system. A tool is needed to qualify medication adherence in order to adapt tailored support for individual patients to promote and optimize adherence to therapy.
The objective of this work is to present the preliminary results of QUILAM project which is divided into 3 phases: 1. Development of a tool to assess barriers to medication adherence in chronic patient (COPD, Heart failure, Type 2 diabetes) ; 2. Validation of the instrument (especially against clinical criteria) ; 3. Evaluation of the sensitivity of the tool during educational interventions.
- Conditions
- Patient Education as Topic, Surveys and Questionnaires, Medication Adherence, Pulmonary Disease, Chronic Obstructive, Diabetes Mellitus, Type 2, Heart Failure
- Keywords
- Surveys and Questionnaires, Patient Education as Topic, Medication Adherence, Pulmonary Disease, Chronic Obstructive, Diabetes Mellitus, Type 2, Heart failure
- Medical subject headings
- Medication Adherence, Pulmonary Disease, Chronic Obstructive, Diabetes Mellitus, Type 2, Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of events 'hospitalization and death' for 2 patient groups defined through the questionnaire QUILAM score
Measured: 12 month
Secondary outcomes (5)
Feasibility and acceptability of the questionnaire (duration / missing data)
Measured: 12 month
Reliability over time of the questionnaire (test-retest J0 - J15)
Measured: 12 month
External construct validity (Girerd, SatMedQ, BMQ)
Measured: 12 month
Number of clinical events for 2 patient groups
Measured: 12 month
Number of events 'hospitalization and death' for 2 patient groups separate with different cut off
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startMar 2013
- Primary completionAug 2020
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Education as TopicStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 282 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoît ALLENET, PharmD, PHD, Study director, TIMC-IMAG UMR 5525 / ThEMAS, University Grenoble-Alpes/ Grenoble University Hospital, Grenoble, France/Aurelie Gauchet, PHD, Study director, Inter-University Laboratory of Psychology (LIP), University Grenoble-Alpes, Grenoble, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865525
- Sponsor's protocol ID
- 38RC14.084
- Acronym
- QUILAM
- Status last verified
- Oct 2020
- First submitted
- 4 Aug 2016
- Last updated
- 26 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QUILAM : Development and Validation of a Self-administered QUestionnaire to Identify Levers of Adhesion Behavior to Patient's Medication in Order to Adapt the Educational Monitoring
- ClinicalTrials.gov ID
- NCT02865525
- Acronym / sponsor ID
- QUILAM / 38RC14.084
- Conditions
- Patient Education as Topic, Surveys and Questionnaires, Medication Adherence, Pulmonary Disease, Chronic Obstructive, Diabetes Mellitus, Type 2, Heart Failure
- Keywords
- Surveys and Questionnaires, Patient Education as Topic, Medication Adherence, Pulmonary Disease, Chronic Obstructive, Diabetes Mellitus, Type 2, Heart failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- Aug 2020 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 12 Aug 2016 (estimated)
- 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.
Medication non-adherence is an economic problem and a major public health challenge. Factors influencing medication adherence can be modelled according to five dimensions: disease, medication, patient and its close relatives, demographic and socioeconomic factors and health care system. A tool is needed to qualify medication adherence in order to adapt tailored support for individual patients to promote and optimize adherence to therapy.
The objective of this work is to present the preliminary results of QUILAM project which is divided into 3 phases: 1. Development of a tool to assess barriers to medication adherence in chronic patient (COPD, Heart failure, Type 2 diabetes) ; 2. Validation of the instrument (especially against clinical criteria) ; 3. Evaluation of the sensitivity of the tool during educational interventions.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- targeted pathologies: type 2 diabetes heart failure Chronic obstructive pulmonary disease
Key inclusion criteria (3 listed)
- Patient with at least one of the following pathologies: diabetes type II, COPD, heart failure
- person available for a follow-up of 1 year
- Affiliated to the social security or recipient of such a regime
Key exclusion criteria (2 listed)
- Persons referred to in articles L1121-5 and L1121-8 in the french public health code
- Patient who do not speak french
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
Number of events 'hospitalization and death' for 2 patient groups defined through the questionnaire QUILAM score
Time frame: 12 month
5 secondary outcomes
Feasibility and acceptability of the questionnaire (duration / missing data)
Time frame: 12 month
Reliability over time of the questionnaire (test-retest J0 - J15)
Time frame: 12 month
External construct validity (Girerd, SatMedQ, BMQ)
Time frame: 12 month
Number of clinical events for 2 patient groups
Time frame: 12 month
Number of events 'hospitalization and death' for 2 patient groups separate with different cut off
Time frame: 12 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 26 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Benoît ALLENET, PharmD, PHD study director
TIMC-IMAG UMR 5525 / ThEMAS, University Grenoble-Alpes/ Grenoble University Hospital, Grenoble, France/
Aurelie Gauchet, PHD study director
Inter-University Laboratory of Psychology (LIP), University Grenoble-Alpes, Grenoble, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Education as Topic and Surveys and Questionnaires, run by University Hospital, Grenoble 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 3 inclusion and 2 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 26 Oct 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?
Number of events 'hospitalization and death' for 2 patient groups defined through the questionnaire QUILAM score (time frame: 12 month). 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 26 Oct 2020; AzTrials last refreshed its copy on 1 Nov 2026.