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)

October 23, 2020 updated by: University Hospital, Grenoble

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

282

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble cedex 9, France, 38043
        • Grenoble University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

targeted pathologies: type 2 diabetes heart failure Chronic obstructive pulmonary disease

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2013

Primary Completion (Actual)

August 1, 2020

Study Completion (Actual)

August 1, 2020

Study Registration Dates

First Submitted

August 4, 2016

First Submitted That Met QC Criteria

August 9, 2016

First Posted (Estimate)

August 12, 2016

Study Record Updates

Last Update Posted (Actual)

October 26, 2020

Last Update Submitted That Met QC Criteria

October 23, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC14.084

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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