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.

Sponsor

University Hospital, Grenoble (Other)

Overall Status

Completed

CT.gov ID

NCT02865525

Collaborator

(none)

282

Enrollment

Location

Actual Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Patient Education as Topic Surveys and Questionnaires Medication Adherence Pulmonary Disease, Chronic Obstructive Diabetes Mellitus, Type 2 Heart Failure

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

282 participants

Observational Model:

Other

Time Perspective:

Prospective

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

Actual Study Start Date :

Mar 1, 2013

Actual Primary Completion Date :

Aug 1, 2020

Actual Study Completion Date :

Aug 1, 2020

Outcome Measures

Primary Outcome Measures

Number of events 'hospitalization and death' for 2 patient groups defined through the questionnaire QUILAM score [12 month]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Grenoble University Hospital	Grenoble cedex 9		France	38043

Sponsors and Collaborators

University Hospital, Grenoble

Investigators

Study Director: Benoît ALLENET, PharmD, PHD, TIMC-IMAG UMR 5525 / ThEMAS, University Grenoble-Alpes/ Grenoble University Hospital, Grenoble, France/
Study Director: Aurelie Gauchet, PHD, Inter-University Laboratory of Psychology (LIP), University Grenoble-Alpes, Grenoble, France