Iatrogenic Drug Risk in People Over 75, With or Without C... | NCT03686943

Studies
Iatrogenic Drug Risk in People Over 75, With or Without Cognitive Disorders, From an Inventory of Their Family Pharmacy

NCT03686943

Sponsor

University Hospital, Tours

Status

Withdrawn

Last Update Posted

Sep 26, 2019Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Elderly
Iatrogenic Drug Risk

Interventions

Family pharmacy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2018-A02122-53	Other Identifier	IdRCB

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Abandoned project

Expanded Access Info

Start Date

Jun 28, 2019Estimated

Primary Completion Date

Jun 28, 2019Actual

Completion Date

Jun 28, 2019Actual

First Submitted Date

Sep 21, 2018

First Submission Date that Met QC Criteria

Sep 25, 2018

First Posted Date

Sep 27, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 25, 2019

Last Update Posted Date

Sep 26, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Elderly		Patient over 75 years seen with the mobile extra hospital geriatric team	Other: Family pharmacy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Family pharmacy	Other	Observation of the family pharmacy in elderly group	Elderly

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	At the inclusion (baseline)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient over 75 years with or without cognitive disorders

Exclusion Criteria:

Refusal to participate

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

75 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Patient over 75 years seen with the mobile extra hospital geriatric team

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Julie BOURGUEIL, MD	University Hospital, Tours	Principal Investigator

Locations

Not provided