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Digital Transformation of Continuity of Care for Peripherally Inserted Central Catheters: SpadCare Experience

ConditionsInfusions, IntravenousAdministration, IntravenousHome Infusion TherapyParenteral Nutrition, HomeCentral Venous CathetersCatheterization, Central VenousCatheterization, PeripheralVascular Access DevicesPatient Education as TopicPatient ParticipationUser-Computer InterfaceSmartphoneMobile ApplicationsComputers, HandheldDigital HealthNursingCare GiversDelivery of Health CareHome NursingSelf AdministrationAdverse EffectsCatheter-Related InfectionsTelemedicine
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundacion Miguel Servet

About this trial

The study focuses on patients who require outpatient infusion of therapy ("Infusions, Intravenous"\[Mesh\]) "Administration, Intravenous"\[Mesh\] ("Home Infusion Therapy"\[Mesh\]) "Parenteral Nutrition, Home"\[Mesh\] via a peripherally inserted central catheter (PICC) ("Central Venous Catheters"\[MeSH\] "Catheterization, Central Venous"\[MeSH\] "Catheterization, Peripheral" \[MeSH\] "Vascular Access Devices"\[Mesh\] )

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients >18 years.

Sign the informed consent form.

Have a Smartphone and accept the use of the APP.

Patient with a PICC inserted by the Infusion and Vascular Access Team of the University Hospital of Navarra and with a planned use of at least one month.

Disqualifiers

Patients with limitations in the use of digital resources or lack of Smartphone.

Patients who do not want to install the APP on their Smartphone

Patients who do not authorize access to their Computerized Medical Record (HCI).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Digital Transformation of Continuity of Care for Peripherally Inserted Central Catheters

    Other intervention

    The application is offered to all patients at the time of PICC placement. If they accept, they go to the intervention group. If they do not accept, they go to the control group.

Treatment groups

201 Participants
are divided into 2 treatment groups
Group A: Smart phone APPExperimental treatment 1 intervention
Group B: Control armNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

1. Patients who use computerized applications are more involved in their care and have fewer complications with the PICC

Number of phlebitis episodes

Time frame
At the end of intervention: Time from PICC placement to removal.
2

1. Patients who use computerized applications are more involved in their care and have fewer complications with the PICC.

Number of episodes of catheter removal by reason for removal: pain

Time frame
At the end of intervention: Time from PICC placement to removal.
3

1. Patients who use computerized applications are more involved in their care and have fewer complications with the PICC.

Number of infection episodes

Time frame
At the end of intervention: Time from PICC placement to removal.
4

1. Patients who use computerized applications are more involved in their care and have fewer complications with the PICC.

Number of episodes of withdrawal reason due to accidental exit

Time frame
At the end of the intervention: Time from PICC placement to removal.

Secondary outcomes

1

Patient experience

Patient satisfaction with the use of the app, through the questionnaire CSUQ: Computer System Usability Questionnaire. The CSUQ scale, or System Usability Satisfaction Questionnaire, is a tool used to assess user satisfaction with a specific system. It is a Likert-type measurement scale, where participants evaluate their level of satisfaction with various aspects of a system, generally on a scale ranging from 1 (totally disagree) to 7 (totally agree).

Time frame
At the end of using the application: Time from PICC placement to removal.
2

Patient experience

Patient satisfaction with the use of the app, through the questionnaire eHEALS. The eHealth Literacy Scale (eHEALS) is a tool that measures eHealth literacy by assessing individuals' subjective perception of their skills and knowledge in using online health resources. The questionnaire consists of eight questions that are answered on a Likert scale, where scores range from 1 (Strongly disagree) to 5 (Strongly agree).

Time frame
At the end of using the application: Time from PICC placement to removal.
3

Patient Satisfaction

Overall satisfaction questionnaire with SpadCare, generated by the research team. SpadCare Questionnaire: 1 the worst value to 10 the best value How would you rate the SpadCare application you have just tested? From 1 to 10, where 1 means 'very dissatisfied' and 10 means 'very satisfied' How likely are you to recommend it to other patients?

Time frame
At the end of using the application: Time from PICC placement to removal.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundacion Miguel Servet

Lead sponsor

Universidad Pública de Navarra

Collaborator

Source ClinicalTrials.gov
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