Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Subjective Factors of Polymedication in the Elderly: a Qualitative Study of the Perceptions of Patients, Relatives and Referent Physicians.(DOSAGE) (DOSAGE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03309228
Recruitment Status : Recruiting
First Posted : October 13, 2017
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Brief Summary:
The DOSAGE Study is a qualitative transversal study aiming to describe and understand the subjective factors of polymedication in the elderly population (75 years old and more), defined as 10 simultaneous drugs. Semi-structured interviews will be conducted with patients, relatives and general practitioners in one French region. 20 situations will be included. After analysing the data of the individual interviews, focus groups will be conducted with health professionals.

Condition or disease Intervention/treatment
Frail Elderly Syndrome Other: individual interviews

Layout table for study information
Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Subjective Factors of Polymedication in the Elderly: a Qualitative Study of the Perceptions of Patients, Relatives and Referent Physicians.(DOSAGE)
Actual Study Start Date : November 16, 2016
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2022

Group/Cohort Intervention/treatment
Qualitative Research
Semi-structured interviews with patients, relatives and general practitioners.
Other: individual interviews
Semi-structured individual interviews with patients, relatives and general practitioners.




Primary Outcome Measures :
  1. 60 semi-structured interviews [ Time Frame: 9 months ]
    Qualitative data analysis - Theorical saturation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Men and women aged 75 and over, fulfilling the conditions of major polymedication: (10 different simultaneous drugs)
Criteria

Inclusion Criteria:

  • For patients:

    • Men and women aged 75 and over
    • Beneficiary of a prescription of medicinal products fulfilling the conditions of major polymedication: to include 10 different drugs whatever the way of use (per os, subcutaneous, intravenous, intra muscular, cutaneous, instillation)
    • Informed consent stating that the subject understood the purpose and methodology of the study and agrees to participate in the study.
  • For the relatives:

    • Men and women 18 years of age or older
    • Informed consent
    • Regularly participating in helping the patient's daily life
  • For Physicians :

    • Identified as the patient's physician or family physician.
    • Informed consent

Exclusion Criteria:

  • Persons with proven and significant cognitive impairment preventing the completion of semi-strutured interviews
  • Person who does not speak French easily
  • Generally, any person unlikely to cooperate in the study
  • Adults under guardianship
  • Refusal of relatives and/or general practitioner to participate to the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309228


Contacts
Layout table for location contacts
Contact: Régis Pr AUBRY 03 81 66 85 18 raubry@chu-besancon.fr
Contact: Elodie CRETIN 03 81 21 86 80 ecretin@chu-besancon.fr

Locations
Layout table for location information
France
CHU de Besançon Recruiting
Besançon, France
Contact: Stéphanie Servagui, MD    0033370632323      
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03309228    
Other Study ID Numbers: DOSAGE
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Besancon:
elderly people
polymedication,
ethics
qualitative research