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

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] )

Study Overview

• Status: Recruiting
• Conditions: Telemedicine; Patient Participation; Mobile Applications; Catheter-Related Infections; Adverse Effects; User-Computer Interface; Delivery of Health Care; Catheterization, Peripheral; Nursing; Digital Health; Patient Education as Topic; Vascular Access Devices; Smartphone; Catheterization, Central Venous; Home Nursing; Self Administration; Parenteral Nutrition, Home; Central Venous Catheters; Home Infusion Therapy; Infusions, Intravenous; Computers, Handheld; Administration, Intravenous; Care Givers
• Intervention / Treatment: Other: Digital Transformation of Continuity of Care for Peripherally Inserted Central Catheters

Detailed Description

The patients, who receive training ("Patient Education as Topic"[Mesh] "patient participation"[MeSH Terms] ) via an app on their personal mobile phone ("User-Computer Interface"[Mesh] "Smartphone"[MeSH] "Mobile Applications"[MeSH] "Computers, Handheld"[Mesh] "Digital Health"[Mesh] are able to perform specialized care ("Nursing"[Mesh]) Care"[MeSH] "Delivery of Health Care"[Mesh:NoExp] "Home Nursing"[MeSH] "Self Administration"[Mesh] to reduce complications ("adverse effects"[MeSH Subheading] "Catheter-Related Infections"[Mesh] ) so that they are monitored in real time by those responsible for the catheter. ("Telemedicine"[Mesh]

• Study Type: Interventional
• Enrollment (Estimated): 201
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: María Inés Corcuera Martínez MI Corcuera Martínez, RN-PhD(c); Phone Number: +34 687609658; Email: mi.corcuera.martinez@navarra.es

Study Locations

• Spain
  • Navarre
    • Pamplona, Navarre, Spain, 31003
      • Recruiting
      • Hospital Universitario de Navarra
      • Contact: María Inés Corcuera Martínez MI Corcuera Martínez, RN-PhD(c); Phone Number: +34 687609658; Email: mi.corcuera.martinez@navarrra.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smart phone APP; Patients who agree to participate in the study, once the PICC is placed, download the app to their personal Smartphone or that of a family member. The app contains all the information about the catheter, including the insertion date, gauge, number of lumens, batch number, and more. The weekly catheter care is performed at home, at the health center, or in the hospital and can be performed by nursing professionals or properly trained family members or caregivers of the patient. The patient reports any incidents that may occur each week. If an incident occurs, the responsible professional contacts the patient by phone and, if necessary, makes an appointment for an in-person consultation to review the catheter. The patient records the care performed in the app and a reminder is automatically recorded in the phone calendar. The app has documentation prepared by expert personnel along with video procedures for the care, and the "step-by-step" feature that allows the care to be performed.	Other: Digital Transformation of Continuity of Care for Peripherally Inserted Central Catheters; 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.; Other Names: SpadCare Experience
No Intervention: Control arm; Usual care description: Patients in the intervention group only have information about their catheter (placement date, catheter reference and batch) on a paper card; they do not have documentary or audiovisual resources. The treatment is carried out exclusively by nursing professionals at the hospital or health centre, and the latter are the ones who contact the hospital professionals who placed it in the event of an incident. The professionals who inserted the catheter are aware of the information about the catheter removal and whether there has been any significant complication when reviewing the catheters they have inserted at the end of the year, and are not aware of the incidents until the annual review. The under-registration in computer applications means that information on a high number of inserted catheters is not available.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Patients who use computerized applications are more involved in their care and have fewer complications with the PICC	Number of phlebitis episodes	At the end of intervention: Time from PICC placement to removal.
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	At the end of intervention: Time from PICC placement to removal.
1. Patients who use computerized applications are more involved in their care and have fewer complications with the PICC.	Number of infection episodes	At the end of intervention: Time from PICC placement to removal.
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	At the end of the intervention: Time from PICC placement to removal.
1. Patients who use computerized applications are more involved in their care and have fewer complications with the PICC.	Number of episodes of skin lesions	At the end of intervention: Time from PICC placement to removal.
1. Patients who use computerized applications are more involved in their care and have fewer complications with the PICC.	Number of thrombosis episodes	At the end of intervention: Time from PICC placement to removal.
1. Patients who use computerized applications are more involved in their care and have fewer complications with the PICC.	Number of episodes of catheter breakage as a reason for removal	At the end of intervention: Time from PICC placement to removal.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	At the end of using the application: Time from PICC placement to removal.
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).	At the end of using the application: Time from PICC placement to removal.
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?	At the end of using the application: Time from PICC placement to removal.

Collaborators and Investigators

• Sponsor: Fundacion Miguel Servet
• Collaborators: Universidad Pública de Navarra

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2023
• Primary Completion (Actual): April 1, 2025
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: February 19, 2025
• First Submitted That Met QC Criteria: March 25, 2025
• First Posted (Actual): April 1, 2025

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Telemedicine; Patient Education as Topic; Mobile Applications; Vascular Access Devices; Catheterization, Peripheral
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Infections; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Patient Acceptance of Health Care; Hyperphagia; Catheter-Related Infections; Patient Participation
• Other Study ID Numbers: 38_NAV2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No