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NCT Number: NCT02865525

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.

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Key information

Conditions

Patient Education as Topic Behavior Cardiovascular Diseases Chronic Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Disease Attributes Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Heart Diseases Heart Failure Lung Diseases Lung Diseases, Obstructive Medication Adherence Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Surveys and Questionnaires Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Grenoble University Hospital

Grenoble, 38043, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of events 'hospitalization and death' for 2 patient groups defined through the questionnaire QUILAM score

    Time frame: 12 month

Secondary outcomes

  1. Feasibility and acceptability of the questionnaire (duration / missing data)

    Time frame: 12 month

  2. Reliability over time of the questionnaire (test-retest J0 - J15)

    Time frame: 12 month

  3. External construct validity (Girerd, SatMedQ, BMQ)

    Time frame: 12 month

  4. Number of clinical events for 2 patient groups

    Time frame: 12 month

  5. Number of events 'hospitalization and death' for 2 patient groups separate with different cut off

    Time frame: 12 month

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study 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

Acronym: QUILAM

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
Aug 12, 2016
Registry last updated
Oct 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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