NCT03309228

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 16, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 13, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

July 18, 2018

Status Verified

October 1, 2017

Enrollment Period

3 years

First QC Date

October 10, 2017

Last Update Submit

July 16, 2018

Conditions

Keywords

elderly peoplepolymedication,ethicsqualitative research

Outcome Measures

Primary Outcomes (1)

  • 60 semi-structured interviews

    Qualitative data analysis - Theorical saturation

    9 months

Study Arms (1)

Qualitative Research

Semi-structured interviews with patients, relatives and general practitioners.

Other: individual interviews

Interventions

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

Qualitative Research

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Besançon

Besançon, France

RECRUITING

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2017

First Posted

October 13, 2017

Study Start

November 16, 2016

Primary Completion

November 1, 2019

Study Completion

November 1, 2022

Last Updated

July 18, 2018

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations