Safer Use of Medication in Pediatric Patients at Home | NCT04598139

Studies
Safer Use of Medication in Pediatric Patients at Home

NCT04598139

Sponsor

Universidad Miguel Hernandez de Elche

Status

Unknown status

Last Update Posted

May 18, 2022Actual

Enrollment

62Estimated

Phase

Not provided

Conditions

Medication Errors and Other Product Use Errors and Issues

Interventions

Study group

Countries

Spain

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

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 5, 2021Actual

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Oct 8, 2020

First Submission Date that Met QC Criteria

Oct 15, 2020

First Posted Date

Oct 22, 2020Actual

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

May 17, 2022

Last Update Posted Date

May 18, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mercedes Guilabert Mora, Principal investigator, Universidad Miguel Hernandez de ElchePrincipal Investigator

Lead Sponsor

Universidad Miguel Hernandez de ElcheOTHER

Collaborators

Not provided

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

This study aims:

to develop a web-based notification system for caregivers of pediatric patients that allows to report medication errors and, based on this notification, and to share experiences and alerts about common errors of patients.
to assess de user satisfaction and perceived usefulness of the system.

Participants:

Parents with children who have required drug treatment in the last two months, who have an Internet connection and who agree to participate in the study.

Sample size: 62 participants

Main outcome variable: overall satisfaction

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

62Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group			Other: Study group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Study group	Other	The study group uses a web-based medication error notification system	Study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Satisfaction with the web-based medication error notification system	Overall satisfaction with the web-based medication error notification system by an ad hoc questionnaire	At one month after use of the website

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

To care children aged under 14 years who have required drug treatment in the last two months
To have an Internet connection
To agree to participate in the study.
To be registered in the study web-based notification system
Age > 17 years

Exclusion Criteria:

To be health provider
To care children in residence for minors.
To care children with a life expectancy of less than 2 years.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Parents or caregivers of children aged from 0 to 14 years.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mercedes Gilabert		Elche	Alicante	03202	Spain

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided