NCT02865525

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
282

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 12, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

October 26, 2020

Status Verified

October 1, 2020

Enrollment Period

7.4 years

First QC Date

August 4, 2016

Last Update Submit

October 23, 2020

Conditions

Patient Education as TopicSurveys and QuestionnairesMedication AdherencePulmonary Disease, Chronic ObstructiveDiabetes Mellitus, Type 2Heart Failure

Keywords

Surveys and QuestionnairesPatient Education as TopicMedication AdherencePulmonary Disease, Chronic ObstructiveDiabetes Mellitus, Type 2Heart failure

Outcome Measures

Primary Outcomes (1)

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

    12 month

Secondary Outcomes (5)

  • 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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Persons referred to in articles L1121-5 and L1121-8 in the french public health code
  • Patient who do not speak french

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grenoble University Hospital

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Medication AdherencePulmonary Disease, Chronic ObstructiveDiabetes Mellitus, Type 2Heart Failure

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • 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 DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2016

First Posted

August 12, 2016

Study Start

March 1, 2013

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

October 26, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)