Clinical trial NCT02865525: 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.
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-08-12
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: targeted pathologies: type 2 diabetes heart failure Chronic obstructive pulmonary disease

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Persons referred to in articles L1121-5 and L1121-8 in the french public health code
* Patient who do not speak french

Primary outcomes:
measure: Number of events 'hospitalization and death' for 2 patient groups defined through the questionnaire QUILAM score
timeFrame: 12 month
Secondary outcomes:
measure: Feasibility and acceptability of the questionnaire (duration / missing data)
timeFrame: 12 month
measure: Reliability over time of the questionnaire (test-retest J0 - J15)
timeFrame: 12 month
measure: External construct validity (Girerd, SatMedQ, BMQ)
timeFrame: 12 month
measure: Number of clinical events for 2 patient groups
timeFrame: 12 month
measure: Number of events 'hospitalization and death' for 2 patient groups separate with different cut off
timeFrame: 12 month
Other outcomes:
Locations:
city: Grenoble cedex 9
country: France
facility: Grenoble University Hospital
Study officials:
affiliation: TIMC-IMAG UMR 5525 / ThEMAS, University Grenoble-Alpes/ Grenoble University Hospital, Grenoble, France/
name: Benoît ALLENET, PharmD, PHD
role: STUDY_DIRECTOR
affiliation: Inter-University Laboratory of Psychology (LIP), University Grenoble-Alpes, Grenoble, France
name: Aurelie Gauchet, PHD
role: STUDY_DIRECTOR
References: