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.

Completed

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

• Registration Number: NCT02865525
• Lead Sponsor: University Hospital, Grenoble

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2016-08-04
• Study First Submitted QC: 2016-08-09
• Study First Posted: 2016-08-12
• Primary Completion: 2020-08
• Study Completion: 2020-08
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-23
• Last Update Posted: 2020-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 282

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Grenoble University Hospital; 🇫🇷 Grenoble cedex 9, France