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.

Heart Failure Clinical Trial

— QUILAM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02865525
• Other study ID #: 38RC14.084
• Status: Completed
• Start date: March 2013
• Est. completion date: August 2020

Study information

• Verified date: October 2020
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 282
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
France	Grenoble University Hospital	Grenoble cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

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