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NCT Number: NCT06905119

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

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] )

Recruiting

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Key information

Conditions

Infusions, Intravenous Administration, Intravenous Adverse Effects Behavior Care Givers Catheter-Related Infections Catheterization, Central Venous Catheterization, Peripheral Central Venous Catheters Computers, Handheld Delivery of Health Care Digital Health Health Behavior Home Infusion Therapy Home Nursing Hyperphagia Infections Mobile Applications Nursing Parenteral Nutrition, Home Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Education as Topic Patient Participation Self Administration Signs and Symptoms Signs and Symptoms, Digestive Smartphone Telemedicine Treatment Adherence and Compliance User-Computer Interface Vascular Access Devices

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario de Navarra

Pamplona, Navarre, 31003, Spain

Location status: Recruiting

Location contact

María Inés Corcuera Martínez MI Corcuera Martínez, RN-PhD(c)

CONTACT

[email protected]

+34 687609658

About this study

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]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Digital Transformation of Continuity of Care for Peripherally Inserted Central Catheters

Other

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

Primary outcomes

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

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

    Number of phlebitis episodes

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

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

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

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

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

    Number of infection episodes

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

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

    Number of episodes of withdrawal reason due to accidental exit

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

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

    Number of episodes of skin lesions

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

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

    Number of thrombosis episodes

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

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

    Number of episodes of catheter breakage as a reason for removal

Secondary outcomes

  1. Patient experience

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

    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).

  2. Patient experience

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

    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).

  3. Patient Satisfaction

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

    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?

Study contacts

Contact information is provided by the study sponsor or research team.

María Inés Corcuera Martínez MI Corcuera Martínez, RN-PhD(c)

CONTACT

[email protected]

+34 687609658

Sponsors and collaborators

Lead sponsor

Fundacion Miguel Servet

Other

Collaborators

  • Universidad Pública de Navarra

Registry information

Acronym: SpadCare

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Apr 1, 2025
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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