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Safer Use of Medication in Pediatric Patients at Home

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04598139
Recruitment Status : Enrolling by invitation
First Posted : October 22, 2020
Last Update Posted : October 18, 2021
Sponsor:
Information provided by (Responsible Party):
Mercedes Guilabert Mora, Universidad Miguel Hernandez de Elche

Study Description
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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


Condition or disease Intervention/treatment
Medication Errors and Other Product Use Errors and Issues Other: Study group

Study Design
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Study Type : Observational
Estimated Enrollment : 62 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Safer Use of Medication in Pediatric Patients at Home: Error Reporting Website
Actual Study Start Date : May 5, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Study group Other: Study group
The study group uses a web-based medication error notification system


Outcome Measures
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Primary Outcome Measures :
  1. Satisfaction with the web-based medication error notification system [ Time Frame: At one month after use of the website ]
    Overall satisfaction with the web-based medication error notification system by an ad hoc questionnaire


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Parents or caregivers of children aged from 0 to 14 years.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04598139


Locations
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Spain
Mercedes Gilabert
Elche, Alicante, Spain, 03202
Sponsors and Collaborators
Universidad Miguel Hernandez de Elche
More Information
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Responsible Party: Mercedes Guilabert Mora, Principal investigator, Universidad Miguel Hernandez de Elche
ClinicalTrials.gov Identifier: NCT04598139    
Other Study ID Numbers: PI18/00739
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: October 18, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No