ElderlyRIMPAPNCT03686943
Iatrogenic Drug Risk in People Over 75, With or Without Cognitive Disorders, From an Inventory of Their Family Pharmacy
An observational study of Elderly and Iatrogenic Drug Risk, run by University Hospital, Tours.
Trial summary
Many hospitalizations or emergency room visits are due to problems of iatrogenic medication, especially in elderly patients who are very often polymedicated. Moreover, they are more at risk because of fragility. This has an important socio-economic impact. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elderly, Iatrogenic Drug Risk
- What is being tested?
- Family pharmacy
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 28 Jun 2019to 28 Jun 2019
- 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: Patient over 75 years seen with the mobile extra hospital geriatric team
Who may be able to join
- Patient over 75 years with or without cognitive disorders
Who cannot join
- Refusal to participate
About this study
Many hospitalizations or emergency room visits are due to problems of iatrogenic medication, especially in elderly patients who are very often polymedicated. Moreover, they are more at risk because of fragility. This has an important socio-economic impact. It therefore seems important to act upstream of these adverse events and a review of the drugs available in the homes of elderly patients seems a good starting point.
- Conditions
- Elderly, Iatrogenic Drug Risk
- Being tested
- Family pharmacy
- Keywords
- Elderly, Iatrogenic drug risk, Family pharmacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family pharmacyOther
Observation of the family pharmacy in elderly group
| Study group | Role | What they receive |
|---|---|---|
| Elderly | Patient over 75 years seen with the mobile extra hospital geriatric team Receives: Other: Family pharmacy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iatrogenic drug risk in patients' homes
Description of potential drug contraindications and potential unadvisable drug interactions highlighted from the analysis of the family pharmacy by Theriaque databased
Measured: At the inclusion (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start28 Jun 2019 (estimated)
- Primary completion28 Jun 2019
- Study completion28 Jun 2019
Why it stopped: Abandoned project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie BOURGUEIL, MD, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03686943
- Sponsor's protocol ID
- RIPH3-RNI18 / RIMPAP
- Other IDs
- 2018-A02122-53
- Acronym
- RIMPAP
- Status last verified
- Sep 2019
- First submitted
- 21 Sep 2018
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iatrogenic Drug Risk in People Over 75, With or Without Cognitive Disorders, From an Inventory of Their Family Pharmacy
- ClinicalTrials.gov ID
- NCT03686943
- Acronym / sponsor ID
- RIMPAP / RIPH3-RNI18 / RIMPAP
- Conditions
- Elderly, Iatrogenic Drug Risk
- Keywords
- Elderly, Iatrogenic drug risk, Family pharmacy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Abandoned project
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 28 Jun 2019 (estimated)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 27 Sep 2018 (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.
Many hospitalizations or emergency room visits are due to problems of iatrogenic medication, especially in elderly patients who are very often polymedicated. Moreover, they are more at risk because of fragility. This has an important socio-economic impact. It therefore seems important to act upstream of these adverse events and a review of the drugs available in the homes of elderly patients seems a good starting point.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly | – | Other: Family pharmacyPatient over 75 years seen with the mobile extra hospital geriatric team |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Patient over 75 years seen with the mobile extra hospital geriatric team
Key inclusion criteria (1 listed)
- Patient over 75 years with or without cognitive disorders
Key exclusion criteria (1 listed)
- Refusal to participate
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 |
|---|---|---|
| Family pharmacyObservation of the family pharmacy in elderly group | Other | Elderly |
Primary outcome
Iatrogenic drug risk in patients' homes
Time frame: At the inclusion (baseline)
Description of potential drug contraindications and potential unadvisable drug interactions highlighted from the analysis of the family pharmacy by Theriaque databased
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
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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.
Julie BOURGUEIL, MD principal investigator
University Hospital, Tours
Questions about this trial
What is this clinical trial studying?
An observational study of Elderly and Iatrogenic Drug Risk, run by University Hospital, Tours.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Iatrogenic drug risk in patients' homes (time frame: At the inclusion (baseline)). 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 26 Sep 2019.