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

Frail Elderly Syndrome Clinical Trial

— DOSAGE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03309228
• Other study ID #: DOSAGE
• Status: Recruiting
• Start date: November 16, 2016
• Est. completion date: November 2022

Study information

• Verified date: October 2017
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Régis Pr AUBRY
• Phone: 03 81 66 85 18
• Email: raubry[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 2022
• Est. primary completion date: November 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frail Elderly Syndrome

Intervention

Other:
• individual interviews
Semi-structured individual interviews with patients, relatives and general practitioners.

Locations

Country	Name	City	State
France	CHU de Besançon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	60 semi-structured interviews	Qualitative data analysis - Theorical saturation	9 months