Infusions, IntravenousSpadCareNCT06905119
Digital Transformation of Continuity of Care for Peripherally Inserted Central Catheters: SpadCare Experience
A study testing Digital Transformation of Continuity of Care for Peripherally Inserted Central Catheters in people with Infusions, Intravenous and Administration, Intravenous, run by Fundacion Miguel Servet at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infusions, Intravenous, Administration, Intravenous, Home Infusion Therapy
- What is being tested?
- Digital Transformation of Continuity of Care for Peripherally Inserted Central Catheters
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteSpain
- Study dates
- 4 May 2023to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
María Inés Corcuera Martínez MI Corcuera Martínez, RN-PhD(c) contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario de Navarra
Pamplona, Navarre, 31003
María Inés Corcuera Martínez MI Corcuera Martínez, RN-PhD(c), +34 687609658, mi.corcuera.martinez@navarrra.es
About this study
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] )
Read the 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]
- Conditions
- Infusions, Intravenous, Administration, Intravenous, Home Infusion Therapy, Parenteral Nutrition, Home, Central Venous Catheters, Catheterization, Central Venous
- Being tested
- Digital Transformation of Continuity of Care for Peripherally Inserted Central Catheters
- Keywords
- Catheterization, Peripheral, Vascular Access Devices, Patient Education as Topic, Telemedicine, Mobile Applications
- Medical subject headings
- Hyperphagia, Patient Participation, Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Transformation of Continuity of Care for Peripherally Inserted Central CathetersOther
Also called SpadCare Experience
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.
| Study group | Role | What they receive |
|---|---|---|
| Smart phone APP | Experimental | 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. Receives: Other: Digital Transformation of Continuity of Care for Peripherally Inserted Central Catheters |
| Control arm | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
1. Patients who use computerized applications are more involved in their care and have fewer complications with the PICC
Number of phlebitis episodes
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At the end of intervention: Time from PICC placement to removal.
Secondary outcomes (3)
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).
Measured: 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).
Measured: 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?
Measured: At the end of using the application: Time from PICC placement to removal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start4 May 2023
- Primary completion1 Apr 2025
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infusions, IntravenousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 201 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Miguel Servet
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Pública de Navarra
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905119
- Sponsor's protocol ID
- 38_NAV2
- Acronym
- SpadCare
- Status last verified
- Sep 2025
- First submitted
- 19 Feb 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Transformation of Continuity of Care for Peripherally Inserted Central Catheters: SpadCare Experience
- ClinicalTrials.gov ID
- NCT06905119
- Acronym / sponsor ID
- SpadCare / 38_NAV2
- Conditions
- Infusions, Intravenous, Administration, Intravenous, Home Infusion Therapy, Parenteral Nutrition, Home, Central Venous Catheters, Catheterization, Central Venous
- Keywords
- Catheterization, Peripheral, Vascular Access Devices, Patient Education as Topic, Telemedicine, Mobile Applications
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 201 participants (estimated)
- Lead sponsor
- Fundacion Miguel ServetUniversity, hospital or other
- Collaborators
- Universidad Pública de Navarra
- Study start
- 4 May 2023 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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] )
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smart phone APP | Experimental | Other: Digital Transformation of Continuity of Care for Peripherally Inserted Central CathetersPatients 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. |
| Control arm | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Transformation of Continuity of Care for Peripherally Inserted Central CathetersAlso: SpadCare ExperienceThe 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 | Smart phone APP |
Primary outcome
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
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
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
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
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
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
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
3 secondary outcomes
Patient experience
Time frame: At the end of using the application: Time from PICC placement to removal.
Patient experience
Time frame: At the end of using the application: Time from PICC placement to removal.
Patient Satisfaction
Time frame: At the end of using the application: Time from PICC placement to removal.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
María Inés Corcuera Martínez MI Corcuera Martínez, RN-PhD(c) contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Transformation of Continuity of Care for Peripherally Inserted Central Catheters in people with Infusions, Intravenous and Administration, Intravenous, run by Fundacion Miguel Servet at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact María Inés Corcuera Martínez MI Corcuera Martínez, RN-PhD(c) (+34 687609658, mi.corcuera.martinez@navarra.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.