Frail Elderly SyndromeDOSAGENCT03309228
Subjective Factors of Polymedication in the Elderly: a Qualitative Study of the Perceptions of Patients, Relatives and Referent Physicians.(DOSAGE)
An observational study of Frail Elderly Syndrome, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frail Elderly Syndrome
- What is being tested?
- individual interviews
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 16 Nov 2016to Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Men and women aged 75 and over, fulfilling the conditions of major polymedication: (10 different simultaneous drugs)
Who may be able to join
- 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
Show all 11Show fewer
- Informed consent
- Regularly participating in helping the patient's daily life
- For Physicians :
- Identified as the patient's physician or family physician.
- Informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Besançon
Besançon
Stéphanie Servagui, MD, 0033370632323
About this study
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.
- Conditions
- Frail Elderly Syndrome
- Being tested
- individual interviews
- Keywords
- elderly people, polymedication,, ethics, qualitative research
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individual interviewsOther
Semi-structured individual interviews with patients, relatives and general practitioners.
| Study group | Role | What they receive |
|---|---|---|
| Qualitative Research | Semi-structured interviews with patients, relatives and general practitioners. Receives: Other: individual interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
60 semi-structured interviews
Qualitative data analysis - Theorical saturation
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2017
- Study start16 Nov 2016
- Primary completionNov 2019 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail Elderly SyndromeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03309228
- Sponsor's protocol ID
- DOSAGE
- Acronym
- DOSAGE
- Status last verified
- Oct 2017
- First submitted
- 10 Oct 2017
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subjective Factors of Polymedication in the Elderly: a Qualitative Study of the Perceptions of Patients, Relatives and Referent Physicians.(DOSAGE)
- ClinicalTrials.gov ID
- NCT03309228
- Acronym / sponsor ID
- DOSAGE / DOSAGE
- Conditions
- Frail Elderly Syndrome
- Keywords
- elderly people, polymedication,, ethics, qualitative research
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 16 Nov 2016 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 13 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Qualitative Research | – | Other: individual interviewsSemi-structured interviews with patients, relatives and general practitioners. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Men and women aged 75 and over, fulfilling the conditions of major polymedication: (10 different simultaneous drugs)
Key inclusion criteria (11 listed)
- For patients:
- For the relatives:
- For Physicians :
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| individual interviewsSemi-structured individual interviews with patients, relatives and general practitioners. | Other | Qualitative Research |
Primary outcome
60 semi-structured interviews
Time frame: 9 months
Qualitative data analysis - Theorical saturation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frail Elderly Syndrome, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Régis Pr AUBRY (03 81 66 85 18, raubry@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
60 semi-structured interviews (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2018.