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.

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02865525

Acronym

QUILAM

Enrollment

282

Registered

2016-08-12

Start date

2013-03-31

Completion date

2020-08-31

Last updated

2020-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2, Heart Failure, Medication Adherence, Patient Education as Topic, Pulmonary Disease, Chronic Obstructive, Surveys and Questionnaires

Keywords

Surveys and Questionnaires, Patient Education as Topic, Medication Adherence, Pulmonary Disease, Chronic Obstructive, Diabetes Mellitus, Type 2, Heart failure

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Number of events 'hospitalization and death' for 2 patient groups defined through the questionnaire QUILAM score	12 month

Secondary

Measure	Time frame
Feasibility and acceptability of the questionnaire (duration / missing data)	12 month
Reliability over time of the questionnaire (test-retest J0 - J15)	12 month
External construct validity (Girerd, SatMedQ, BMQ)	12 month
Number of clinical events for 2 patient groups	12 month
Number of events 'hospitalization and death' for 2 patient groups separate with different cut off	12 month

Countries

France

Outcome results