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

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.

Study Overview

• Status: Unknown
• Conditions: Frail Elderly Syndrome
• Intervention / Treatment: Other: individual interviews

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• France
  • Besançon, France
    • Recruiting
    • CHU de Besançon
    • Contact: Stéphanie Servagui, MD; Phone Number: 0033370632323

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Men and women aged 75 and over, fulfilling the conditions of major polymedication: (10 different simultaneous drugs)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
60 semi-structured interviews	Qualitative data analysis - Theorical saturation	9 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besançon

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 16, 2016
• Primary Completion (ANTICIPATED): November 1, 2019
• Study Completion (ANTICIPATED): November 1, 2022

Study Registration Dates

• First Submitted: October 10, 2017
• First Submitted That Met QC Criteria: October 12, 2017
• First Posted (ACTUAL): October 13, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 18, 2018
• Last Update Submitted That Met QC Criteria: July 16, 2018
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: qualitative research; ethics; elderly people; polymedication,
• Other Study ID Numbers: DOSAGE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No