An interventional study of Digital Transformation of Continuity of Care for Peripherally Inserted Central Catheters in Infusions, Intravenous, Administration, Intravenous and Home Infusion Therapy, sponsored by Fundacion Miguel Servet. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-12.
Sponsored by Fundacion Miguel Servet · Not applicable, Interventional, and Treatment
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Among 10 studies in Catheter-Related Infections with a site in Spain — 2 open to participants now, 2 under way, none of them phase 3. Catheter-Related Infections · Spain.
Among the 10 studies in Catheter-Related Infections with a site in Spain, this one is the only one that started in 2023, is one of 7 with no phase, and was the 9th registered.
112 studies on the registry are indexed under Catheter-Related Infections; 18 are open to participants now.
Browse Catheter-Related Infections studies →2 of the 10 studies in Catheter-Related Infections with a site in Spain are open now. Recruiting first, the newest first:
University of Barcelona · Sites in Spain
Ages 18+
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 10 Catheter-Related Infections studies recruiting now, 9 (90%) set no upper age limit and 1 (10%) stops at 75 or younger; 1 takes children under 18; 1 takes healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 1 started in 2023.
This study's planned enrollment of 201 is above the median of 149 across 84 interventional studies indexed under Catheter-Related Infections.
Median enrollment 232 across the 8 interventional studies, 275 across the 2 observational. Of the 7 that completed or were terminated, 1 (14%) have results posted.
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None of the 10 has an industry lead sponsor. The 9 most frequent:
Fundacion Miguel Servet is the lead sponsor of 48 studies on the registry; 21 are open to participants now.
Fundacion Miguel Servet has 1 study filed under Catheter-Related Infections — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Catheter-Related Infections with a site in Spain, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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] )
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]
112 studies on the registry are indexed under Catheter-Related Infections; 18 are open to participants now.
This study's planned enrollment of 201 is above the median of 149 across 84 interventional studies indexed under Catheter-Related Infections.
Browse Catheter-Related Infections studies →Fundacion Miguel Servet is the lead sponsor of 48 studies on the registry; 21 are open to participants now.
Compared within Catheter-Related Infections, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Patient Participation. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
Also known as: SpadCare Experience
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.
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.
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.
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.
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
Time frame: 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
Time frame: 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
Time frame: At the end of intervention: Time from PICC placement to removal.
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.
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.
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.
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2023 to primary completion in Apr 2025, 22 months.
Of 28 non-industry interventional studies with no phase under Catheter-Related Infections, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 36. This study's 22 months is close to that.
Counting every sponsor, half of 31 studies reached it within 22 months; a quarter within 13 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
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Fundacion Miguel Servet